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Biotech catalyst, news and analysis PDUFA tracker
Merlintrader Trading Pub
Biotech catalyst, news and analysis PDUFA tracker
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Biotech Catalyst Calendar 2026: PDUFA & FDA Dates
FDA decisions, PDUFA dates, advisory committees and clinical-trial readouts for publicly traded biotech stocks.
Tables updated: October 22, 2026; glossary reviewed: September 19, 2026This is Merlintrader’s dedicated biotech catalyst calendar. It tracks upcoming FDA decisions, PDUFA target dates, advisory committee meetings, NDA and BLA milestones, regulatory submissions and major clinical-trial readouts for publicly traded biotech and healthcare companies, including selected non-U.S. listings with FDA milestones.
Each entry is designed to show the expected timing, event type, company context and available source trail. The tables separate confirmed dates, conference ranges, estimated company windows and recent history. Each entry links to its sources; the embedded calendar provides a wider archive.
Catalyst dates can change, FDA decisions can arrive early or late and clinical readouts can be postponed. Always confirm each event against company filings, official press releases and regulatory sources before making any trading or investment decision.
Calendar: upcoming catalysts and history
These tables are an editorial selection of events supported by primary sources. Regulatory dates, confirmed presentations and company windows are separated; passed or completed events appear only in history, with their verified status stated. A PDUFA date is a review goal, not a promise of approval.
Confirmed regulatory deadlines: 59 events
| Date / window | Ticker | Company | Event | Status | Sources |
|---|---|---|---|---|---|
| 2026-10-30 | $INO | Inovio Pharmaceuticals, Inc. | INO-3107, DNA immunotherapy — recurrent respiratory papillomatosis in adults. | Confirmed date | Primary source |
| 2026-11-01 | $AGIO | Agios Pharmaceuticals, Inc. | Pyrukynd (mitapivat) — sickle cell disease, accelerated approval pathway. Program detail: PYRUKYND (mitapivat); NDA. | Confirmed date | Primary source |
| 2026-11-10 | $NRXP | NRx Pharmaceuticals, Inc. | FDA goal date (GDUFA) for the Abbreviated New Drug Application (ANDA) of NRx's preservative-free intravenous ketamine. The FDA reclassified the pending amendment from major to minor and revised the goal date to November 10, 2026 (announced September 15, 2026). On October 15, 2026 the company reported a labeling discipline review letter requesting only minor changes. A goal date is not a decision. | Confirmed date | SEC filing Supporting source |
| 2026-11-14 | $BTAI | BioXcel Therapeutics, Inc. | CHAPTER 11 / NASDAQ SUSPENSION — BioXcel filed Chapter 11 on August 27, 2026. Its September 1 filing announced Nasdaq trading suspension effective September 8, with no appeal planned. Igalmi at-home-use sNDA: November 14, 2026 PDUFA retained as a drug regulatory milestone. A favorable FDA decision does not establish recovery for common shareholders. Proposed asset sale is not treated here as a completed transaction. | WARNING: CHAPTER 11 / NASDAQ SUSPENSIONConfirmed date | Primary source Supporting source Supporting source |
| 2026-11-14 | $CYTK | CYTOKINETICS INC | MYQORZO (aficamten) — obstructive hypertrophic cardiomyopathy; extension based on the MAPLE-HCM trial. | Confirmed date | Primary source |
| 2026-11-14 | $SMMT | Summit Therapeutics Inc. | ivonescimab (SMT112) — EGFR-mutated non-squamous NSCLC, after TKI, in combination with chemotherapy | Confirmed date | Primary source |
| 2026-11-22 | $CAPR | CAPRICOR THERAPEUTICS, INC. | deramiocel (CAP-1002), cell therapy — Duchenne muscular dystrophy; refined proposed indication focused on upper limb function. FDA review of the BLA major amendment includes 24-month HOPE-3 open-label extension data and robustness analyses. On 24 August 2026 Capricor announced a three-month extension from 22 August to 22 November 2026. The target date is not an approval. | Confirmed date | Primary source |
| 2026-11-22 | $SVRA | Savara Inc. | Molbreevi (molgramostim), inhalation solution — autoimmune pulmonary alveolar proteinosis. FDA review date extended by three months for a major amendment. | Confirmed date | Primary source |
| 2026-11-25 | $SNY | Sanofi | venglustat, oral glucosylceramide synthase inhibitor — Gaucher disease type 3, neurological manifestations. | Confirmed date | Primary source |
| 2026-11-27 | $BBIO | BridgeBio Pharma, Inc. | BBP-418 — limb-girdle muscular dystrophy LGMD2I/R9. | Confirmed date | Primary source |
| 2026-11-27 | $GSK | GSK | neladalkib (NVL-655) — advanced ALK-positive NSCLC, previously treated with TKI. Formerly a Nuvalent asset, acquired by GSK on July 15, 2026. | Confirmed date | Primary source Supporting source |
| 2026-11-27 | $RPRX | Royalty Pharma plc | neladalkib — ALK-positive non-small cell lung cancer; royalty interest. FDA target action date: November 27, 2026. | Confirmed date | Primary source |
| 2026-11-28 | $PYPD | PolyPid Ltd. | D-PLEX100, local prolonged-release doxycycline depot — prevention of surgical site infections in colorectal surgery | Confirmed date | Primary source |
| 2026-11-30 | $COGT | Cogent Biosciences, Inc. | bezuclastinib, with sunitinib — gastrointestinal stromal tumours previously treated with imatinib. Merlintrader stock hub: COGT. | Confirmed date | Primary source COGT stock hub |
| 2026-11-30 | $RHHBY | F. Hoffmann-La Roche Ltd | giredestrant — adjuvant treatment of ER-positive, HER2-negative early breast cancer, lidERA trial. | Confirmed date | Primary source |
| 2026-11-30 | $VRTX | VERTEX PHARMACEUTICALS INCORPORATED | povetacicept, dual BAFF and APRIL inhibitor — IgA nephropathy, accelerated approval pathway. | Confirmed date | Primary source |
| 2026-11-30 | $ZLAB | Zai Lab Limited | povetacicept — IgA nephropathy; Vertex partner. FDA target action date: November 30, 2026. | Confirmed date | Primary source ZLAB stock hub |
| 2026-12-12 | $ANAB | ANAPTYSBIO, INC | imsidolimab — generalized pustular psoriasis; Vanda partner. FDA target action date: December 12, 2026. | Confirmed date | Primary source ANAB stock hub |
| 2026-12-12 | $VNDA | Vanda Pharmaceuticals Inc. | imsidolimab, IL-36R antagonist — generalized pustular psoriasis. Molecule originated by AnaptysBio; BLA held by Vanda. | Confirmed date | Primary source |
| 2026-12-17 | $CORT | Corcept Therapeutics Incorporated | relacorilant, selective glucocorticoid receptor antagonist — Cushing's syndrome. NDA resubmitted on June 17, 2026 after a CRL on this indication. | Confirmed date | Primary source |
| 2026-12-18 | $CAMX | Camurus AB | CAM2029 (Oclaiz), acromegaly NDA resubmission: FDA target action date confirmed for December 18, 2026. A review target is not an approval. Nasdaq Stockholm ticker CAMX. | Confirmed date | Primary source |
| 2026-12-18 | $RHHBY | F. Hoffmann-La Roche Ltd | giredestrant + everolimus — ER+/HER2− advanced or metastatic breast cancer with an ESR1 mutation, following progression on or after prior endocrine therapy. | Confirmed date | Primary source |
| 2026-12-22 | $MLYS | Mineralys Therapeutics, Inc. | lorundrostat — hypertension in adults, in combination with other antihypertensives. Program detail: lorundrostat; NDA. Merlintrader stock hub: MLYS. | Confirmed date | Primary source MLYS stock hub |
| 2026-12-23 | $GILD | GILEAD SCIENCES, INC. | anito-cel (anitocabtagene autoleucel), anti-BCMA CAR-T — relapsed or refractory multiple myeloma, fourth line. BLA filed by Arcellx, acquired by Gilead on April 28, 2026. | Confirmed date | Primary source |
| 2026-12-27 | $PRAX | Praxis Precision Medicines, Inc. | relutrigine — SCN2A and SCN8A developmental and epileptic encephalopathies (NDA). Date extended from September 27, 2026 for a major amendment. | Confirmed date | Primary source |
| 2026-12-27 | $VTRS | Viatris Inc. | fast-acting meloxicam — moderate to severe acute pain, non-opioid analgesic. Merlintrader stock hub: VTRS. | Confirmed date | Primary source VTRS stock hub |
| 2026-12-30 | $COGT | Cogent Biosciences, Inc. | bezuclastinib monotherapy — non-advanced systemic mastocytosis. Merlintrader stock hub: COGT. | Confirmed date | Primary source COGT stock hub |
| 4 January 2027 | $NUVB | NUVATION BIO INC | PDUFA: IBTROZI (taletrectinib) · advanced ROS1-positive non-small cell lung cancer (NSCLC). Company timing: January 4, 2027. FDA target action date; approval is not assured. | Confirmed date | Primary source |
| 2027-01-21 | $DYN | Dyne Therapeutics, Inc. | z-rostudirsen (DYNE-251) — Duchenne muscular dystrophy amenable to exon 51 skipping. FDA target action date: January 21, 2027. | Confirmed date | Primary source |
| 2027-01-29 | $PRAX | Praxis Precision Medicines, Inc. | ulixacaltamide — essential tremor. FDA target action date: January 29, 2027. | Confirmed date | Primary source |
| 2027-02-04 | $BBIO | BridgeBio Pharma, Inc. | FDA accepted the NDA with Priority Review and assigned a February 4, 2027 PDUFA target, per the October 6 company announcement. Review acceptance is not approval. | Confirmed date | Primary source |
| 2027-02-12 | $BLTE | BELITE BIO, INC | tinlarebant — Stargardt disease type 1. FDA target action date: February 12, 2027. | Confirmed date | Primary source |
| 2027-02-23 | $ARQT | Arcutis Biotherapeutics, Inc. | Zoryve cream 0.05% — atopic dermatitis, infants aged 3 to 24 months. FDA target action date: February 23, 2027. | Confirmed date | Primary source |
| 2027-02-27 | $CGEM | Cullinan Therapeutics, Inc. | zipalertinib — EGFR exon 20 insertion non-small cell lung cancer. FDA target action date: February 27, 2027. | Confirmed date | Primary source |
| 2027-02-28 | $APMD | Apnimed, Inc. | AD109 — obstructive sleep apnea. FDA target action date: February 28, 2027. | Confirmed date | Primary source |
| 2027-02-28 | $BMRN | BioMarin Pharmaceutical Inc. | Voxzogo (vosoritide) — full approval in children with achondroplasia. FDA target action date: February 28, 2027. | Confirmed date | Primary source |
| 2027-02-28 | $SRPT | Sarepta Therapeutics, Inc. | AMONDYS 45 and VYONDYS 53 — Duchenne muscular dystrophy; traditional approval conversion. FDA target action date: February 28, 2027. | Confirmed date | Primary source |
| 2027-03-03 | $EXEL | EXELIXIS, INC. | zanzalintinib + atezolizumab — previously treated metastatic colorectal cancer, STELLAR-303. New target March 3, 2027; December 3, 2026 is no longer an active deadline. FDA notified the company on September 10 that new safety and efficacy data constituted a major amendment; filing dated September 11. | Confirmed date | Primary source |
| 2027-03-10 | $NTLA | Intellia Therapeutics, Inc. | Lonvoguran ziclumeran (lonvo-z/NTLA-2002) for hereditary angioedema: BLA accepted with Priority Review, FDA PDUFA target March 10, 2027. Approval is not assured. One application, one event. | Confirmed date | Primary source Supporting source |
| 2027-03-11 | $BMY | BRISTOL MYERS SQUIBB | Reblozyl (luspatercept) — myelofibrosis-associated anemia. FDA target action date: March 11, 2027. | Confirmed date | Primary source |
| 2027-03-16 | $AQST | Aquestive Therapeutics, Inc. | FDA goal date (PDUFA) for the resubmitted NDA of Anaphylm (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis. The FDA accepted the resubmission, filed on September 16, 2026, as complete and classified it as a Class 2 response (announced October 15, 2026). | Confirmed date | SEC filing |
| 2027-03-22 | $MRK | Merck & Co., Inc. | Enflonsia (clesrovimab-cfor) — children entering a second RSV season at increased risk. FDA target action date: March 22, 2027. | Confirmed date | Primary source |
| 2027-03-25 | $UNCY | Unicycive Therapeutics, Inc. | PDUFA target action date for the resubmitted NDA of oxylanthanum carbonate (OLC), oral phosphate binder for hyperphosphatemia in patients with chronic kidney disease on dialysis. The FDA accepted the resubmission, filed after a Complete Response Letter in June 2026, as a Class II resubmission with a six-month review period from the resubmission date. The resubmission includes CMC data from a new third-party drug product manufacturing vendor; the company does not know whether the FDA will conduct a pre-approval inspection of that vendor. | Confirmed date | Finviz (news) |
| 2027-03-29 | $AQST | Aquestive Therapeutics, Inc. | FDA goal date (PDUFA) for the LIBERVANT (diazepam) buccal film application for patients aged 6 to 11 with seizure clusters, as cited in the October 14, 2026 Eton/Aquestive license announcement. Eton holds the exclusive U.S. commercial rights; Aquestive is the exclusive manufacturer and receives milestones and royalties. | Confirmed date | Primary source |
| 2027-03-29 | $ETON | ETON PHARMACEUTICALS INC | FDA goal date (PDUFA) for the LIBERVANT (diazepam) buccal film application for patients aged 6 to 11 with seizure clusters. Eton licensed exclusive U.S. rights from Aquestive on October 13, 2026 ($10.0 million upfront, up to $47.5 million in milestones, mid-teens royalties). | Confirmed date | Primary source SEC filing |
| 2027-03-31 | $ATRA | Atara Biotherapeutics, Inc. | FDA accepted the Class 2 resubmission of the tabelecleucel (tab-cel) Biologics License Application for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD), announced October 14, 2026 by partner Pierre Fabre Pharmaceuticals. New PDUFA goal date: March 31, 2027. | Confirmed date | Primary source |
| 2027-04-01 | $HRMY | Harmony Biosciences Holdings, Inc. | pitolisant GR — narcolepsy. FDA target action date: April 1, 2027. | Confirmed date | Primary source |
| 14 April 2027 | $INBX | INHIBRX BIOSCIENCES INC | PDUFA: ozekibart (INBRX-109) · Conventional chondrosarcoma. Company timing: April 14, 2027. FDA target action date; approval is not assured. | Confirmed date | Primary source |
| 2027-04-23 | $PHVS | Pharvaris N.V. | deucrictibant IR — on-demand treatment of hereditary angioedema attacks. FDA target action date: April 23, 2027. | Confirmed date | Primary source |
| 2027-04-23 | $RPRX | Royalty Pharma plc | deucrictibant IR — hereditary angioedema; royalty interest. FDA target action date: April 23, 2027. | Confirmed date | Primary source |
| 2027-04-24 | $ORGO | Organogenesis Holdings Inc. | ReNu — symptomatic knee osteoarthritis. FDA target action date: April 24, 2027. | Confirmed date | Primary source |
| 2027-04-28 | $IMNM | IMMUNOME, INC. | varegacestat — desmoid tumors in adults. FDA target action date: April 28, 2027. | Confirmed date | Primary source |
| 2027-05-01 | $AXSM | Axsome Therapeutics, Inc. | AXS-12 (reboxetine) — narcolepsy. FDA target action date: May 1, 2027. | Confirmed date | Primary source |
| 2027-05-08 | $BBIO | BridgeBio Pharma, Inc. | encaleret — autosomal dominant hypocalcemia type 1. FDA target action date: May 8, 2027. | Confirmed date | Primary source |
| 2027-05-13 | $BMY | BRISTOL MYERS SQUIBB | mezigdomide with carfilzomib and dexamethasone — relapsed/refractory multiple myeloma. FDA target action date: May 13, 2027. | Confirmed date | Primary source |
| 2027-05-27 | $ZBIO | Zenas BioPharma, Inc. | obexelimab — IgG4-related disease. FDA target action date: May 27, 2027. | Confirmed date | Primary source |
| 2027-06-14 | $URGN | UROGEN PHARMA LTD | PDUFA: UGN-103 (mitomycin) for intravesical solution · recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). UroGen announced on October 19, 2026 that the FDA accepted the NDA, with a PDUFA target action date of June 14, 2027. Supported by the Phase 3 UTOPIA trial. | Confirmed date | Primary source |
| 2027-06-24 | $UTHR | UNITED THERAPEUTICS CORPORATION | ralinepag — pulmonary arterial hypertension. FDA target action date: June 24, 2027. | Confirmed date | Primary source |
| 2027-06-29 | $COGT | Cogent Biosciences | Bezuclastinib NDA in advanced systemic mastocytosis (AdvSM): FDA target action date June 29, 2027, announced September 15. Separate from GIST November 30 and nonadvanced SM December 30, 2026. Approval is not assured. | Confirmed date | Primary source COGT stock hub |
Full calendar
Want to see the rest of the catalysts?
Below: the remaining confirmed regulatory deadlines, clinical and corporate events with a confirmed day, conferences, company windows and recent history, every entry with its primary source, plus the full event calendar, the Catalyst Lookup and the glossary.
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Clinical and corporate events with a confirmed day: 143 events
| Date / window | Ticker | Company | Event | Status | Sources |
|---|---|---|---|---|---|
| October 22, 2026 | $ABCL | AbCellera Biologics Inc. | ABCL635 TMS poster P-92, October 22 at 6:15-7:15 p.m. PDT: new multiple-ascending-dose Phase 1 safety and Phase 2 patient-reported outcomes in menopausal vasomotor symptoms. This is a presentation of additional data, not the already announced initial Phase 2 topline. | Confirmed date | Primary source |
| October 22, 2026 | $HUMA | Humacyte, Inc. | ASN Kidney Week late-breaking oral TH-OR113 presents V012 Phase 3 interim findings in women needing hemodialysis access on October 22, 4:40–4:50 p.m. Mountain Time. ATEV is compared with autogenous arteriovenous fistula. | Confirmed date | Company release |
| 2026-10-22 | $ICU | SeaStar Medical | ASN late-breaking poster TH-PO1291: postapproval SAVE pediatric sepsis-associated AKI registry compared with a historical cohort, 10 a.m.–noon Mountain Time. Distinct from the adult pivotal trial. | Confirmed date | Primary source |
| 2026-10-22 | $IMUX | Immunic, Inc. | MSToronto2026 (10th Joint ACTRIMS-ECTRIMS Meeting), Poster Session 2, Thursday, October 22, 2026, 4:30–6:30 p.m. ET: paper poster P1273 with preclinical data on Nurr1-dependent neuronal survival and neuroprotective effects of vidofludimus calcium in murine MS models. Preclinical data, not a clinical readout. | Confirmed date | Primary source |
| 2026-10-22 | $KPTI | Karyopharm Therapeutics Inc. | End of the lender forbearance period at 11:59 p.m. Eastern on October 22, 2026, after the parties moved it on October 13 from October 15 (8-K filed October 14). The forbearance follows the missed principal installment of approximately $15.8 million due September 10 under the term loan; the defaults are not waived and the period can end earlier if specified termination events occur. | Confirmed date | SEC filing SEC filing |
| 2026-10-22 | $LBRX | LB Pharmaceuticals Inc. | Craig-Hallum Biotech Catalyst Conference: virtual fireside chat at 10:00 a.m. ET and virtual one-on-one investor meetings on Thursday, October 22, 2026. Webcast on the company investor website. An investor conference appearance, not a data release. | Confirmed date | Primary source |
| October 22, 2026 | $MAZE | Maze Therapeutics, Inc. | ASN poster TH-PO0213 on preclinical SLC6A19 inhibition and a protective proximal-tubule metabolic state relevant to MZE782, October 22, 10:00 am-noon MT. Not clinical efficacy data. | Confirmed date | Primary source |
| 2026-10-22 | $PYPD | PolyPid Ltd. | IDWeek 2026 (Washington, D.C.), Late Breaking Abstracts: Antimicrobials, oral presentation on Thursday, October 22, 2026 (session 10:30–11:45 a.m. ET): exploratory pooled microbiology analysis of SHIELD I, SHIELD II and the Phase 2 trial of D-PLEX100 (2,185 patients). Exploratory analysis of completed trials, not a new primary-endpoint result. | Confirmed date | Finviz (news) |
| 2026-10-22 | $VERA | Vera Therapeutics, Inc. | Investor webcast on Thursday, October 22, 2026, at 4:30 p.m. ET to discuss the ORIGIN 3 final efficacy analysis of TRUTAKNA (atacicept-vymj) in IgA nephropathy, presented as a late-breaking oral in the ASN Kidney Week 2026 opening plenary. With Jonathan Barratt, PhD, FRCP (University of Leicester); live Q&A follows. | Confirmed date | Primary source |
| 2026-10-22 | $ZBIO | Zenas BioPharma, Inc. | MSToronto MoonStone Phase 2 posters P1417, P1411 and P1455, 4:30–6:30 p.m. ET: 24-week relapsing-MS clinical results, serum biomarkers and PK/PD analyses, grouped as one same-program session. | Confirmed date | Primary source Supporting source |
| October 22, 2026 | $ZBIO | ZENAS BIOPHARMA INC | MSToronto poster P1446, October 22, 4:30–6:30 p.m. ET: 24-week efficacy and safety of orelabrutinib 80 mg in the randomized Phase 2 RRMS study. Not a Phase 3 readout. | Confirmed date | Primary source Supporting source |
| 2026-10-23 | $ALNY | Alnylam Pharmaceuticals, Inc. | ALN-HTT02 Phase 1 initial results at EHDN; presentation date October 23, 2026 announced in Q2 results. | Confirmed date | Primary source |
| 2026-10-23 | $ARDX | Ardelyx, Inc. | ASN posters on hyperphosphatemia management: real-world tenapanor/phosphate-binder use, patient perspectives and cumulative morbidity/mortality; not a pivotal interventional readout. | Confirmed date | Company release |
| 2026-10-23 | $CELC | Celcuity Inc. | ESMO poster 2237P: Phase 1b subgroup analyses in metastatic castration-resistant prostate cancer. Separate from the Phase 2 Q4 2026 readout. | Confirmed date | Primary source |
| 2026-10-23 | $EIKN | Eikon Therapeutics, Inc. | ESMO Congress 2026 (Madrid) posters on Friday, October 23, 2026, 15:15 – 16:00: 1048P, Phase 1/2 study of the PARP1-selective inhibitor EIK1003 as monotherapy and with paclitaxel in advanced solid tumors; 1049P, Phase 1/2 study of EIK1003 with abiraterone in metastatic prostate cancer; 1060P, first-in-human Phase 1/2 study of the CNS-penetrant PARP1-selective inhibitor EIK1004 in advanced solid tumors with HRR mutations; 1010P, safety, tolerability and PK of the WRN inhibitor EIK1005. Full-text abstracts published October 18. | Confirmed date | Primary source |
| 2026-10-23 | $GSK | GSK plc | ESMO Congress 2026 (Madrid, October 23-27), Friday, October 23, 15:15-16:00 CET, Poster Session: 1071P (S. Goel), EMBOLD PanTumor-101 safety and efficacy of risvutatug rezetecan (Ris-Rez), GSK's investigational B7-H3-targeted antibody-drug conjugate, as monotherapy during dose escalation in a global population with advanced/metastatic solid tumours; 1068P (J. Zugazagoitia), pooled analysis of interstitial lung disease cases among patients with advanced solid tumours who received Ris-Rez monotherapy. | Confirmed date | Primary source |
| 2026-10-23 | $INCY | INCYTE | ESMO Congress 2026 (Madrid) rapid oral 1241RO, Friday, October 23, 10:15-11:45 a.m. ET (4:15-5:45 p.m. CET): preliminary efficacy of INCB123667 (CDK2 inhibition) with bevacizumab in recurrent epithelial ovarian cancer. | Confirmed date | Primary source |
| 2026-10-23 | $IOVA | Iovance Biotherapeutics, Inc. | ESMO Congress 2026: proffered-paper oral presentation (abstract 2072O) of final results from the IOV-COM-202 study of lifileucel plus pembrolizumab in immune checkpoint inhibitor-naive advanced melanoma, Friday, October 23, 2026, 16:15–17:45 CEST; same day, poster 4359P on enrichment of putative tumor-reactive clones in NSCLC patients responding to lifileucel (single-cell analysis), 15:15–16:00 CEST. | Confirmed date | Primary source |
| 2026-10-23 | $KYTX | Kyverna Therapeutics, Inc. | MSToronto oral presentation, 11:05–11:15 a.m. ET: updated safety and preliminary efficacy from an investigator-initiated Phase 1 study of miv-cel in progressive multiple sclerosis. | Confirmed date | Primary source Supporting source |
| October 23, 2026 | $MAZE | Maze Therapeutics, Inc. | ASN poster FR-PO0215 on preclinical SLC6A19 inhibition and reduced nephrotoxin uptake relevant to MZE782, October 23, 10:00 am-noon MT. Separate poster; not clinical efficacy data. | Confirmed date | Primary source |
| 2026-10-23 | $PROK | ProKidney Corp. | ASN poster FR-PO0498: pooled Phase 2 safety/efficacy in CKD with diabetes among participants meeting key Phase 3 eligibility criteria, 10 a.m.–noon MDT; not Phase 3 efficacy results. | Confirmed date | Primary source |
| 2026-10-23 | $SCYX | SCYNEXIS, Inc. | SCY-247, the company's second-generation triterpenoid antifungal candidate, featured in an oral company pipeline presentation at IDWeek 2026 in Washington, D.C.: "SCY-247, a novel phase 2 IV/oral triterpenoid antifungal", session New Antimicrobials in the Pipeline, Friday, October 23, 2026 at 8:00 a.m. ET. | Confirmed date | Primary source |
| October 23, 2026 | $TGTX | TG THERAPEUTICS INC | First Phase 1 azer-cel data in primary progressive multiple sclerosis: MSToronto late-breaking oral presentation O135, October 23, 10:45–10:55 a.m. ET. Abstract release October 21. | Confirmed date | Primary source |
| 2026-10-23 | $TNGX | Tango Therapeutics, Inc. | PDAC-focused investor webcast and conference call on Friday, October 23, 2026, at 7:30 am ET to discuss the vopimetostat plus RAS(ON) inhibitor combination data that the company will present at ESMO 2026 (poster 3149P, October 25). Live webcast under Events & Presentations on the company website, replay for at least 30 days. | Confirmed date | Primary source |
| 23 October 2026 | $ZLAB | ZAI LAB LTD | Zai Lab investor webcast on zocilurtatug pelitecan (zoci) at ESMO: October 23, 2026 at 08:00 ET / 20:00 HKT. Separate from the October 26 poster presentation; no results are inferred in advance. Calendar uses an all-day reminder with the announced start time in this description because no end time is published. | Confirmed date | Primary source ZLAB stock hub |
| 2026-10-23 | $ZNTL | Zentalis Pharmaceuticals, Inc. | ESMO Congress 2026 (Madrid) rapid oral presentation 1242RO (Rapid Oral Presentation — Gynecological Cancers: Ovarian), Friday, October 23, 2026, 4:15 p.m. – 5:45 p.m. CEST: overall survival from an interim analysis of DENALI Part 1b (GOG-3066) with azenosertib in platinum-resistant ovarian cancer. The published abstract reports, as of the September 2, 2025 data cutoff, median OS of 15.8 months (95% CI, 8.7–17.8) in the Cyclin E1-positive subgroup (n=48) and 7.5 months (95% CI, 5.8–12.3) in the Cyclin E1-negative subgroup (n=46), with no new safety signals; OS is a secondary endpoint and Cyclin E1 status was determined retrospectively. Distinct from the DENALI Part 2 readout. | Confirmed date | Primary source |
| 2026-10-24 | $AMGN | AMGEN INC | Webcast call for the investment community in conjunction with ESMO 2026 on Saturday, October 24, 2026, at 11:30 a.m. PT, on Amgen's oncology portfolio and selected data presented at the congress. An investor event, not a new data release. | Confirmed date | Primary source |
| 2026-10-24 | $CELC | Celcuity Inc. | ESMO oral presentation of VIKTORIA-1 subgroup analyses in advanced breast cancer. Abstract release scheduled October 19. | Confirmed date | Primary source |
| 2026-10-24 | $CLYM | Climb Bio Inc | ASN oral presentation of preliminary PrisMN Phase 2 safety and efficacy data in primary membranous nephropathy, 5:30–5:40 p.m. Mountain Time. | Confirmed date | Primary source |
| 2026-10-24 | $CMPX | Compass Therapeutics, Inc. | COMPANION-002 tovecimig oral presentation at ESMO 2026. Confirmed date: session on October 24, 2026, 10:15–11:45 a.m. CET; individual presentation time not stated. Compass Therapeutics will present results of the randomized Phase 2/3 COMPANION-002 trial of tovecimig plus paclitaxel in advanced biliary tract cancer at ESMO on October 24, 2026. | Confirmed date | Primary source |
| 2026-10-24 | $GSK | GSK plc | ESMO Congress 2026 (Madrid), Saturday, October 24, 8:30-10:00 CET, Rapid Oral Session: late-breaking LBA41 (V. Salutari), updated results with longer follow-up from the global Phase I BEHOLD-1 study of mocertatug rezetecan (Mo-Rez), GSK's investigational B7-H4-targeted antibody-drug conjugate, in platinum-resistant ovarian cancer; 1248RO (S. Lheureux), BEHOLD-1 exploratory analysis of biomarkers associated with Mo-Rez response in platinum-resistant ovarian cancer. | Confirmed date | Primary source |
| 2026-10-24 | $INCY | INCYTE | ESMO Congress 2026 (Madrid) rapid oral 1954RO, Saturday, October 24, 2:30-4:00 a.m. ET (8:30-10:00 a.m. CET): INCA33890, a TGFβR2xPD-1 bispecific antibody, with standard-of-care anticancer therapies in microsatellite stable colorectal cancer. | Confirmed date | Primary source |
| 2026-10-24 | $IOVA | Iovance Biotherapeutics, Inc. | ESMO Congress 2026: two posters on Saturday, October 24, 2026, 12:00–12:45 CEST, in anti-PD-1-resistant advanced melanoma: 2117P, indirect comparison of overall survival between lifileucel and standard of care in US real-world settings; 2125P, matching-adjusted indirect comparison of lifileucel versus nivolumab plus relatlimab. | Confirmed date | Primary source |
| 2026-10-24 | $LLY | Eli Lilly and Company | ESMO Congress 2026 (Madrid, October 23–27), Saturday, October 24: rapid oral 1246RO (Rapid oral 2: Gynecological cancers, 8:30-10:00 CET) with first Phase 1 data for sofetabart mipitecan (Sofe-M), Lilly's investigational FRα-targeting ADC, plus bevacizumab in recurrent platinum-sensitive ovarian cancer; rapid oral 1RO (Rapid oral 1: Breast cancer, advanced stage, 10:15-11:45 CET) with overall survival from the Phase 3 postMONARCH trial of Verzenio (abemaciclib) plus fulvestrant vs placebo plus fulvestrant in HR+, HER2– advanced breast cancer after progression on a prior CDK4/6 inhibitor and endocrine therapy. | Confirmed date | Primary source |
| October 24, 2026 | $MAZE | Maze Therapeutics, Inc. | ASN Kidney Week oral presentation of updated detail from previously reported Phase 2 HORIZON MZE829 data in APOL1-mediated kidney disease, October 24 at 5:40-5:50 pm MT. This is a presentation of earlier-reported results, not a new topline readout. | Confirmed date | Primary source |
| 24 October 2026 | $PBLS | PARABILIS MEDICINES INC | Conference presentation: zolucatetide · desmoid tumor (Phase 1/2). Company timing: October 24, 2026. Congress: ESMO Congress. | Confirmed date | Primary source Supporting source |
| 2026-10-24 | $REGN | Regeneron Pharmaceuticals, Inc. | ESMO poster 2490P: final Phase 2 analysis of neoadjuvant cemiplimab in resectable stage II–IV cutaneous squamous cell carcinoma. | Confirmed date | Primary source |
| 2026-10-24 | $REGN | Regeneron Pharmaceuticals, Inc. | ESMO poster 2091P: long-term overall survival follow-up from Phase 1 in advanced melanoma. | Confirmed date | Primary source |
| 2026-10-24 | $VERA | VERA THERAPEUTICS INC | ASN oral presentation of interim Phase 2 PIONEER results in adult IgA nephropathy and primary membranous nephropathy, 5:30–5:40 p.m. MDT. Narrows the prior Q4 window. | Confirmed date | Primary source |
| 25 October 2026 | $ANAB | ANAPTYSBIO INC | Conference presentation: Jemperli (dostarlimab) · Untreated stage II/III dMMR/MSI-H locally advanced rectal cancer AZUR-1 (pivotal Phase 2). Company timing: October 25, 2026. Congress: ESMO Congress. | Confirmed date | Primary source Supporting source ANAB stock hub |
| 2026-10-25 | $GRAL | GRAIL, Inc. | ESMO poster 1164P on diagnostic workups after positive MCED blood tests in clinical practice is scheduled October 25, 12:00–12:45 conference local time. | Confirmed date | Primary source |
| 2026-10-25 | $GSK | GSK / AnaptysBio | ESMO Congress 2026 (Madrid), Sunday, October 25, 10:15-11:45 CET, Proffered Paper Session: LBA87 (A. Cercek), "Clinical complete response with dostarlimab monotherapy in dMMR/MSI-H locally advanced rectal cancer (LARC): First results from the global registrational AZUR-1 trial" (Jemperli). This conference presentation is separate from the FDA review of Jemperli in rectal cancer. Sources: https://www.gsk.com/en-gb/media/press-releases/gsk-showcases-pipeline-momentum-across-lung-gynaecological-and-gastrointestinal-cancers-at-esmo-2026/ | https://www.sec.gov/Archives/edgar/data/1370053/000119312526396690/anab-ex99_1.htm | Confirmed date | Primary source SEC filing |
| 2026-10-25 | $INBX | INHIBRX BIOSCIENCES INC | ESMO Congress 2026 (Madrid), Sunday, October 25, 2026, 8:30-10:00 AM CET: oral presentation (lead author Jong Chul Park) of the phase 2 primary analysis of HexAgon-HN, a phase 2/3 study of the hexavalent OX40 agonist ordastobart (INBRX-106) in combination with pembrolizumab as first-line treatment of PD-L1-high recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). | Confirmed date | Primary source |
| 2026-10-25 | $INCY | INCYTE | ESMO Congress 2026 (Madrid) rapid oral 1007RO, Sunday, October 25, 3:30-5:00 a.m. ET (8:30-10:00 a.m. CET): safety and efficacy of the oral KRAS G12D inhibitor INCB161734 as monotherapy or with cetuximab in advanced/metastatic colorectal cancer. | Confirmed date | Primary source |
| 2026-10-25 | $LLY | Eli Lilly and Company | ESMO Congress 2026 (Madrid), Sunday, October 25, 8:30-10:00 CET: rapid oral 2652RO (Rapid oral 2: NSCLC, metastatic) with updated integrated results from the Phase 1/2 LOXO-RAS-20001 trial and the safety lead-in of the Phase 3 SUNRAY-01 trial of olomorasib, Lilly's investigational KRAS G12C inhibitor, with chemoimmunotherapy (pembrolizumab, pemetrexed and platinum) as first-line treatment of advanced/metastatic KRAS G12C-mutant NSCLC. | Confirmed date | Primary source |
| 2026-10-25 | $MYGN | Myriad Genetics, Inc. | ESMO Congress 2026, Sunday, October 25, 2026: MONSTAR-SCREEN-3 data on the whole-genome-sequencing-based Precise MRD assay. Proffered paper on ultrasensitive ctDNA detection for molecular residual disease assessment in resectable colorectal cancer (Proffered Paper 1: Basic Science and Translational Research, Burgos Auditorium – Hall 3, 2:45-4:15 p.m.) and poster 3138P on MRD detection in resectable pancreatic cancer (12:00-12:45 p.m.). | Confirmed date | Primary source |
| 2026-10-25 | $REGN | Regeneron Pharmaceuticals, Inc. | ESMO late-breaking Phase 3 C-POST overall survival update at approximately 3.5 years in adjuvant high-risk cutaneous squamous cell carcinoma. | Confirmed date | Primary source |
| 2026-10-25 | $SMMT | Summit Therapeutics Inc. | ESMO 2026 (Madrid) oral presentation, Proffered Paper 2 Session: Genitourinary Tumours, Renal and Urothelial, October 25, 9:32-9:42 a.m. CET, Abstract #3592O: efficacy and safety of ivonescimab (AK112) as first-line treatment for IMDC favorable-risk advanced renal cell carcinoma, results from a Phase Ib/II investigator-sponsored study. | Confirmed date | Primary source |
| 2026-10-25 | $SMMT | Summit Therapeutics / Akeso | HARMONi-GI1 Phase 3 biliary-tract cancer presentation, ESMO Presidential Symposium II, Abstract LBA8, October 25, 5:42-5:54 p.m. CET (session 16:30-18:15 CET / 11:30-13:15 EDT). The company describes positive overall survival findings; Akeso-sponsored study conducted in China, with all relevant data generated, managed and analyzed by Akeso. Separate from the November 14 NSCLC PDUFA. | Confirmed date | Primary source Supporting source |
| 2026-10-25 | $TNGX | TANGO THERAPEUTICS INC | ESMO Congress 2026 (Madrid, October 23-27), Sunday, October 25, 12:00-12:45 pm CEST: poster 3149P (presenter Alexander I. Spira, MD, PhD, FACP, NEXT Oncology) with updated data from the Phase 1/2 study of vopimetostat in combination with daraxonrasib or zoldonrasib in patients with MTAP-deleted, RAS-mutant (MTAPdel/RASmut) metastatic pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). The abstract data cutoff is April 3, 2026; the poster will include updated data. | Confirmed date | Primary source |
| 2026-10-26 | $EIKN | Eikon Therapeutics, Inc. | ESMO Congress 2026 (Madrid) posters on Monday, October 26, 2026, 12:00 – 12:45: 2664P, TeLuRide-005 Phase 2 study of the TLR7/8 dual agonist EIK1001 plus pembrolizumab and chemotherapy in stage IV NSCLC, with results from the squamous cohort and updated pooled results; 2724TiP, design of the Phase 2/3 TeLuRide-008 trial of EIK1001 with pembrolizumab and chemotherapy in stage 4 NSCLC. Full-text abstracts published October 18. | Confirmed date | Primary source |
| 2026-10-26 | $GRAL | GRAIL, Inc. | PATHFINDER 2 cancer-signal-origin-guided diagnostic workups, abstract 1151, scheduled within the October 26 ESMO rapid-oral session 14:45–16:15. This is a session window, not a confirmed individual talk time. | Confirmed date | Primary source |
| 2026-10-26 | $GSK | GSK plc | ESMO Congress 2026 (Madrid), Monday, October 26: Rapid Oral Session 8:35-10:00 CET, 3718RO (S. Bauer), molecular response in KIT circulating tumour DNA from StrateGIST 1, Phase 1/1b study of velzatinib (IDRX-42) in advanced gastrointestinal stromal tumours; Poster Session 12:00-12:45 CET, 3841P (H. R. Kim), EMBOLD PanTumor-101 Ris-Rez dose optimisation in extensive-stage small cell lung cancer; Presidential Symposium 16:30-18:15 CET, LBA9 (L. Xie), late-breaking data presented by GSK's licensor Hansoh Pharma: primary results from the Phase 3 ARTEMIS-011 study of Ris-Rez versus gemcitabine and docetaxel in heavily pretreated relapsed or refractory osteosarcoma. | Confirmed date | Primary source |
| 2026-10-26 | $INCY | INCYTE | ESMO Congress 2026 (Madrid) rapid oral 3137RO, Monday, October 26, 9:45-11:15 a.m. ET (2:45-4:15 p.m. CET): safety and efficacy of INCB161734, an oral KRAS G12D inhibitor, with chemotherapy in advanced/metastatic pancreatic ductal adenocarcinoma. The same day, from 2:30 to 4:00 p.m. ET, Incyte hosts an investor event and webcast to discuss key data presented at ESMO and provide portfolio updates. | Confirmed date | Primary source |
| 2026-10-26 | $IOVA | IOVANCE BIOTHERAPEUTICS INC | ESMO Congress 2026: rapid oral presentation (abstract 3725RO) of lifileucel in previously treated undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS), Monday, October 26, 2026, 08:30–10:00 CEST. Data from a pilot trial led by Memorial Sloan Kettering Cancer Center and supported by Iovance; the registrational SARATOGA trial in UPS and DDLPS is ongoing. | Confirmed date | Primary source SEC filing |
| 2026-10-26 | $LLY | Eli Lilly and Company | ESMO Congress 2026 (Madrid), Monday, October 26, 10:15-11:45 CET: proffered paper 4208O (NETs and endocrine tumors) with updated results of the randomized Phase 3 LIBRETTO-531 study of Retevmo (selpercatinib) vs cabozantinib or vandetanib in advanced, kinase inhibitor-naïve, RET-mutant medullary thyroid cancer. The same day, 12:00-12:45, posters 1288P (Sofe-M in patients aged 65 or older with platinum-resistant and -sensitive ovarian cancer) and 2683P (first-line olomorasib plus pembrolizumab in KRAS G12C-mutant NSCLC). | Confirmed date | Primary source |
| 2026-10-26 | $REGN | Regeneron Pharmaceuticals, Inc. | ESMO Phase 2 ROXI-CATH subanalysis of catheter-related venous thromboembolism in patients with active cancer. | Confirmed date | Primary source |
| 2026-10-26 | $SMMT | Summit Therapeutics Inc. | ESMO 2026 (Madrid) rapid oral presentation, Rapid Oral Session: Non-metastatic NSCLC and Other Thoracic Malignancies, October 26, 11:07-11:12 a.m. CET, Abstract #4156RO: ivonescimab plus chemotherapy as first-line treatment in recurrent/metastatic thymic carcinoma, results from the iTHYM Phase II investigator-sponsored study. | Confirmed date | Primary source |
| 26 October 2026 | $ZLAB | ZAI LAB LTD | ESMO poster 3817P (abstract 1569): zocilurtatug pelitecan (zoci), ZL1310-001 phase 1 parts 1b/1c, with atezolizumab with or without carboplatin in first-line extensive-stage SCLC. Poster date: October 26, 2026. Company release lists 12:00–12:45 CEST; timezone label is reproduced as published, not converted. ESMO congress runs October 23–27 in Madrid. | Confirmed date | Primary source ZLAB stock hub |
| 2026-10-27 | $NAUT | Nautilus Biotechnology, Inc. | Third-quarter 2026 financial results before market open on Tuesday, October 27, 2026, followed by a webcast conference call at 8:30 a.m. ET (5:30 a.m. PT). | Confirmed date | Primary source |
| 2026-10-27 | $PHAR | Pharming Group N.V. | Full preliminary third-quarter 2026 financial results and business update on October 27, 2026, brought forward from November 5, followed by a conference call and webcast at 13:30 CET / 8:30 a.m. EDT. Preliminary figures released October 22: total revenues of approximately $117.6 million, up about 21% year over year. | Confirmed date | Primary source |
| 2026-10-27 | $PROK | ProKidney Corp. | Virtual key opinion leader event on Tuesday, October 27, 2026, at 10:30 a.m. ET: new insights into rilparencel's mechanism of action from research presented at ASN Kidney Week 2026, the potential role of rilparencel in advanced stage 3b/4 CKD with type 2 diabetes, a corporate update and a live Q&A. | Confirmed date | Primary source |
| 2026-10-28 | $AMRN | Amarin Corporation plc | Third-quarter 2026 financial results released in the pre-market hours of Wednesday, October 28, 2026, followed by a conference call with senior management at 8:00 a.m. ET. | Confirmed date | Finviz (news) |
| 2026-10-28 | $BEAM | Beam Therapeutics Inc. | ESGCT 33rd Annual Congress (Hamburg): poster with initial Phase 1/2 data for BEAM-301 in glycogen storage disease type Ia on October 28, 2026 (Poster Session I, P0219). Beam will review the data on an investor webcast on October 27 at 8:00 a.m. ET. | Confirmed date | Primary source |
| 2026-10-28 | $PYPD | PolyPid Ltd. | Virtual Investor Day "PolyPid 2030" on Wednesday, October 28, 2026, at 11:30 a.m. ET: management to outline its long-term growth and pipeline strategy, provide an update on D-PLEX (NDA under FDA Priority Review, PDUFA goal date November 28, 2026) and introduce PD01B, a new product candidate based on the Kynatrix delivery technology being developed for the treatment of diabetic foot infections. | Confirmed date | Primary source |
| 2026-10-28 | $REPL | Replimune Group, Inc. | Conference call on Wednesday, October 28, 2026, at 8:00 a.m. ET to discuss financial results and provide a corporate update for the fiscal second quarter ended September 30, 2026. | Confirmed date | Primary source |
| 2026-10-28 | $VKTX | Viking Therapeutics, Inc. | Third-quarter 2026 financial results released after the market close on Wednesday, October 28, 2026, followed by a conference call on financial results and general corporate updates at 4:30 p.m. ET. | Confirmed date | Primary source |
| 2026-10-28 | $VNDA | Vanda Pharmaceuticals Inc. | Third-quarter 2026 financial results to be released after the market close on Wednesday, October 28, 2026, followed by a conference call at 4:30 p.m. ET. | Confirmed date | Primary source |
| 2026-10-29 | $BBIO | BridgeBio Pharma, Inc. | Third-quarter 2026 financial results and business update released after the market closes on Thursday, October 29, 2026, followed by a conference call on financial results and program updates at 4:30 p.m. ET the same day. | Confirmed date | Primary source |
| 2026-10-29 | $INBX | INHIBRX BIOSCIENCES INC | 2026 Musculoskeletal Tumor Society (MSTS) Annual Meeting (Miami, Florida), Thursday, October 29, 2026, 2:50-3:40 PM EST: oral presentation (lead author Robin Jones) of secondary efficacy endpoints from the randomized, registrational, Phase 2 ChonDRAgon study of the tetravalent death receptor 5 (DR5) agonist ozekibart (INBRX-109) in conventional chondrosarcoma. | Confirmed date | Primary source |
| 2026-10-29 | $LENZ | LENZ Therapeutics, Inc. | Webcast on Thursday, October 29, 2026, at 8:30 a.m. EDT to report third-quarter 2026 financial results. | Confirmed date | Primary source |
| 2026-10-29 | $STOK | Stoke Therapeutics, Inc. | Webcast and conference call for analysts and investors on Thursday, October 29, 2026, at 4:30 p.m. ET to discuss third-quarter 2026 business and financial updates. | Confirmed date | Finviz (news) |
| 2026-11-02 | $KRYS | KRYSTAL BIOTECH INC | Third-quarter 2026 financial results on Monday, November 2, 2026, before the U.S. market opens, followed by a conference call and webcast at 8:30 a.m. ET with a business update. | Confirmed date | Primary source |
| 2 November 2026 | $RXRX | RECURSION PHARMACEUTICALS INC | Conference presentation: REC-4881 · Familial adenomatous polyposis. Company timing: 2 November 2026. Congress: CGA-IGC Annual Meeting. | Confirmed date | Primary source Supporting source |
| 2026-11-03 | $ALKS | ALKERMES PLC | Third-quarter 2026 financial results discussed on a conference call and webcast at 8:00 a.m. ET (1:00 p.m. GMT) on Tuesday, November 3, 2026. | Confirmed date | Finviz (news) |
| 2026-11-03 | $ARDX | Ardelyx, Inc. | Third-quarter 2026 financial results and business update on a webcast and conference call on Tuesday, November 3, 2026, at 4:30 p.m. ET. | Confirmed date | Primary source |
| 2026-11-03 | $MDGL | Madrigal Pharmaceuticals, Inc. | Third-quarter 2026 financial results before the open of the U.S. financial markets on Tuesday, November 3, 2026, followed by a live webcast at 8:00 a.m. ET. | Confirmed date | Primary source |
| 2026-11-03 | $ZVRA | Zevra Therapeutics, Inc. | Third-quarter 2026 corporate and financial results via news release after the market close on Tuesday, November 3, 2026, followed by a conference call and audio webcast at 4:30 p.m. ET. | Confirmed date | Primary source |
| 2026-11-04 | $ARQT | Arcutis Biotherapeutics, Inc. | Third-quarter 2026 financial results and business update released after the U.S. financial markets close on Wednesday, November 4, 2026, followed by a conference call and webcast at 4:30 p.m. ET. | Confirmed date | Finviz (news) |
| 2026-11-04 | $BCRX | BioCryst Pharmaceuticals, Inc. | Third-quarter 2026 financial results reported on Wednesday, November 4, 2026, with a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update. | Confirmed date | Primary source |
| 2026-11-04 | $BLLN | BillionToOne, Inc. | Third-quarter 2026 financial results after the market close on Wednesday, November 4, 2026, followed by a conference call at 1:30 p.m. PT / 4:30 p.m. ET the same day, with a live and archived webcast. | Confirmed date | Primary source Supporting source |
| 2026-11-04 | $CYTK | CYTOKINETICS INC | Third-quarter 2026 results reported on Wednesday, November 4, 2026 at 4:00 p.m. ET, followed by a conference call by senior management at 4:30 p.m. ET to discuss financial results and provide business updates. | Confirmed date | Primary source |
| 2026-11-04 | $GERN | Geron Corporation | Third-quarter 2026 financial results and business highlights before the market opens on Wednesday, November 4, 2026, followed by a conference call and webcast at 8:00 a.m. ET. | Confirmed date | Finviz (news) |
| 2026-11-04 | $GRAL | GRAIL, Inc. | Third-quarter 2026 financial results released following the close of market on Wednesday, November 4, 2026, followed by a webcast and conference call at 1:30 p.m. PT / 4:30 p.m. ET on results and business progress. | Confirmed date | Primary source |
| 2026-11-04 | $OCGN | Ocugen, Inc. | Conference call and live webcast on Wednesday, November 4, 2026 at 8:30 a.m. ET to provide a business update and report third-quarter 2026 financial results. | Confirmed date | Primary source |
| 2026-11-04 | $SMMT | Summit Therapeutics Inc. | Virtual special meeting of stockholders on Wednesday, November 4, 2026, at 11:00 a.m. ET, to vote on an amendment to the Restated Certificate of Incorporation increasing authorized common stock by 1,000,000,000 shares (from 1,000,000,000 to 2,000,000,000). Record date: close of business October 1, 2026. | Confirmed date | SEC filing |
| 2026-11-04 | $STIM | Neuronetics, Inc. | Third-quarter 2026 financial and operating results released prior to market open on Wednesday, November 4, 2026, followed by a conference call and webcast at 8:30 a.m. ET. | Confirmed date | Finviz (news) |
| 2026-11-04 | $VIR | Vir Biotechnology, Inc. | Conference call at 4:30 p.m. ET / 1:30 p.m. PT on Wednesday, November 4, 2026 to provide a corporate update and discuss financial results for the third quarter ended September 30, 2026. | Confirmed date | Primary source |
| 2026-11-04 | $VRDN | VIRIDIAN THERAPEUTICS INC | Third-quarter 2026 financial results before the market opens on Wednesday, November 4, 2026, followed by a live conference call at 8:00 a.m. ET with a business update. | Confirmed date | Finviz (news) |
| 2026-11-05 | $AGIO | Agios Pharmaceuticals, Inc. | Third-quarter 2026 financial results and business highlights on a conference call and live webcast on Thursday, November 5, 2026, at 8:00 a.m. ET. | Confirmed date | Primary source |
| 2026-11-05 | $CATX | Perspective Therapeutics, Inc. | NANETS oral abstract 36595: cohort 1–3 safety and efficacy in advanced SSTR2-positive neuroendocrine tumors. Issuer lists November 5 within the 4:10–5:25 p.m. PST session; no individual talk time is supplied. | Confirmed date | Primary source Supporting source Trial registry Supporting source |
| 2026-11-05 | $IVA | Inventiva S.A. | AASLD poster 1052: plasma cell-free DNA methylation across PPAR isoforms in MASLD. Mechanistic/translational research; not the NATiV3 Phase 3 topline. | Confirmed date | Primary source |
| 2026-11-05 | $NYXH | Nyxoah SA | Third-quarter 2026 financial results on November 5, 2026, with a webcast, as listed in the company investor events calendar. | Confirmed date | Primary source |
| 2026-11-05 | $RNXT | RenovoRx | Third-quarter 2026 financial results and business highlights released after market close on Thursday, November 5, 2026, followed by a conference call and webcast at 4:30 p.m. ET. | Confirmed date | Primary source |
| 2026-11-05 | $SRPT | Sarepta Therapeutics, Inc. | Third-quarter 2026 financial results reported after the Nasdaq Global Market closes on Thursday, November 5, 2026, followed by a conference call at 4:30 p.m. ET to discuss the results. | Confirmed date | Primary source |
| 2026-11-05 | $VCEL | Vericel Corporation | Third-quarter 2026 financial results on Thursday, November 5, 2026, with a conference call and webcast at 8:30 a.m. ET on financial results and business highlights. | Confirmed date | Primary source |
| 2026-11-05 | $VERA | Vera Therapeutics, Inc. | Third-quarter 2026 financial results and business updates on a live investor webcast on Thursday, November 5, 2026, at 4:30 p.m. ET. | Confirmed date | Primary source |
| 2026-11-05 | $VSTM | Verastem, Inc. | Conference call and webcast on Thursday, November 5, 2026, at 4:30 p.m. ET to discuss third-quarter 2026 financial results and business updates. | Confirmed date | Primary source |
| 2026-11-05 | $XERS | XERIS BIOPHARMA HOLDINGS INC | Financial results and business highlights for the third quarter ended September 30, 2026 released before the open of the U.S. financial markets on Thursday, November 5, 2026, followed by a conference call and webcast at 8:30 a.m. ET that day. | Confirmed date | Primary source |
| 2026-11-05 | $ZLAB | Zai Lab Limited | Third-quarter 2026 financial results and recent corporate updates on November 5, 2026, before the opening of U.S. equity markets, followed by a conference call and webcast at 8:00 a.m. ET (9:00 p.m. HKT). | Confirmed date | Primary source |
| 2026-11-06 | $CADL | Candel Therapeutics, Inc. | SITC poster 603: multi-omics and immune-activation analyses with aglatimagene plus valacyclovir in NSCLC progressing despite checkpoint inhibitors. | Confirmed date | Primary source |
| 2026-11-06 | $CATX | Perspective Therapeutics, Inc. | SITC poster 571: VMT01 mono- and combination therapy with nivolumab in previously treated unresectable or metastatic melanoma. Abstract details due November 3. | Confirmed date | Primary source Trial registry |
| 2026-11-06 | $MRNA | Moderna, Inc. | Moderna reports third-quarter 2026 financial results and provides a corporate update on Friday, November 6, 2026, with a webcast at 8:00 a.m. ET. | Confirmed date | Primary source |
| 2026-11-07 | $AGEN | Agenus Inc. | SITC clinical poster 472: characteristics of long-term survivors with refractory MSS metastatic colorectal cancer treated with BOT+BAL. | Confirmed date | Primary source |
| 2026-11-07 | $CADL | Candel Therapeutics, Inc. | SITC poster 468: Phase 1b clinical and mechanistic findings for linoserpaturev combined with VEGF blockade in recurrent glioblastoma. | Confirmed date | Primary source |
| 2026-11-07 | $IVA | Inventiva S.A. | AASLD posters 3552 and 3570: liver endothelial/vascular findings spanning preclinical models and Phase 2b analyses, plus preclinical hepatic-cell fibrosis mechanisms. Grouped same-day presentations; not NATiV3 results. | Confirmed date | Primary source |
| November 8, 2026 | $CGEM | Cullinan Therapeutics, Inc. | Velinotamig: multidose data from the Genrix Bio Phase 1 dose-escalation study in systemic lupus erythematosus, poster presentation at ACR Convergence on November 8, 2026, 10:30 a.m.–12:30 p.m. Eastern. | Confirmed date | Primary source |
| 2026-11-08 | $CRSP | CRISPR Therapeutics AG | ACR poster 0225: Phase 1 safety and efficacy in refractory systemic sclerosis, November 8 at 10:30 a.m. ET. Specific subset presentation; broader H2 autoimmune/oncology guidance remains separate. | Confirmed date | Primary source |
| 2026-11-08 | $EDIT | Editas Medicine, Inc. | AHA Scientific Sessions, November 8, 3:30–4:45 p.m. CT: preclinical durability of LDL-C reduction with EDIT-401 in non-human primates. Not human clinical data. | Confirmed date | Primary source |
| 2026-11-08 | $GILD | GILEAD SCIENCES, INC. | The Liver Meeting 2026 (AASLD, Denver, November 5-9): late-breaking oral presentation of Phase 3 IDEAL results on seladelpar for alkaline phosphatase normalization in primary biliary cholangitis (abstract #5007) on November 8, 2026. Gilead's program includes 21 accepted abstracts, among them a late-breaking fatigue poster on seladelpar (#5040, November 8), up-to-five-year seladelpar data and long-term and real-world Hepcludex (bulevirtide-gmod) data in chronic hepatitis delta. | Confirmed date | Finviz (news) |
| 8 November 2026 | $MLYS | MINERALYS THERAPEUTICS INC | Transform-HTN open-label extension: long-term efficacy and safety of lorundrostat in uncontrolled hypertension. Late-breaking AHA Scientific Sessions presentation on November 8 at 3:30 p.m. CT, Chicago. This is a clinical presentation, separate from the December PDUFA target. Company timing: November 8, 2026. Congress: AHA Scientific Sessions. | Confirmed date | Primary source Supporting source MLYS stock hub |
| 2026-11-09 | $ANTX | AN2 Therapeutics, Inc. | Guggenheim 3rd Annual Healthcare Innovation Conference (November 9–11, 2026): fireside chat with the CEO on Monday, November 9, 2026, at 9:30 a.m. ET, with a webcast. An investor conference appearance, not a data release. | Confirmed date | Finviz (news) |
| November 9, 2026 | $ARTV | Artiva Biotherapeutics, Inc. | AlloNK (AB-101) plus rituximab updated Phase 2a basket data in refractory RA, Sjögren disease and systemic sclerosis at ACR 2026. Oral session November 9, 3:00-4:30 pm EST; investor webcast 8:15 am EST. | Confirmed date | Primary source |
| November 9, 2026 | $CRSP | CRISPR Therapeutics AG | CTX310 Phase 1b results in severe hypertriglyceridemia: AHA late-breaking oral presentation November 9, 2026 at 8:00 a.m. CST. Data remain embargoed until presentation. Specifies the previously guided H2 2026 Phase 1b update; separate from Phase 1a ESC durability results. | Confirmed date | Primary source Supporting source |
| 2026-11-09 | $GENB | GENERATE BIOMEDICINES INC | Presentation at the Guggenheim 3rd Annual Healthcare Innovation Conference in Boston on Monday, November 9, 2026, at 1:00 p.m. ET, with live webcast. An investor conference appearance, not a data release. | Confirmed date | Primary source |
| 2026-11-09 | $IMVT | IMMUNOVANT INC | Financial results for the second fiscal quarter ended September 30, 2026 reported on Monday, November 9, 2026 before the market opens. Roivant Sciences, Immunovant's majority stockholder, hosts a live conference call and webcast at 8:00 a.m. ET that day, including a business update for Immunovant. | Confirmed date | Primary source |
| 2026-11-09 | $LBRX | LB Pharmaceuticals Inc. | Guggenheim Securities 3rd Annual Healthcare Innovation Conference (Boston, MA): fireside chat at 1:00 p.m. ET and one-on-one investor meetings on Monday, November 9, 2026. Webcast on the company investor website. An investor conference appearance, not a data release. | Confirmed date | Primary source |
| 2026-11-09 | $SENS | Senseonics Holdings, Inc. | Third-quarter 2026 financial results released after market close on Monday, November 9, 2026, followed by a conference call and webcast at 4:30 p.m. ET. | Confirmed date | Finviz (news) |
| 2026-11-09 | $ZYME | Zymeworks Inc. | Third-quarter 2026 financial results, after market close on November 9, 2026. No conference call or webcast planned. | Confirmed date | Primary source |
| 2026-11-10 | $ANTX | AN2 Therapeutics, Inc. | Stifel 2026 Healthcare Conference (November 10–12, 2026): corporate overview by the CEO on Tuesday, November 10, 2026, at 8:40 a.m. ET, with a webcast. An investor conference appearance, not a data release. | Confirmed date | Finviz (news) |
| November 10, 2026 | $ARTV | Artiva Biotherapeutics, Inc. | AlloNK (AB-101) plus rituximab safety and B-cell depletion data from a 60-patient rheumatology cohort, ACR poster 2384 November 10, 10:30 am-12:30 pm EST. Separate poster from the November 9 oral efficacy update; overlapping patients are possible. | Confirmed date | Primary source |
| 2026-11-10 | $EPRX | Eupraxia Pharmaceuticals Inc. | Eupraxia fireside chat at the Stifel 2026 Healthcare Conference (New York, November 10-12, 2026) on November 10, 2026, at 4:40 p.m. ET, with webcast and one-on-one meetings. An investor conference appearance, not a data release. | Confirmed date | Primary source |
| 2026-11-10 | $IPHA | Innate Pharma S.A. | Innate Pharma will participate in a fireside chat at the Stifel Healthcare Conference (New York, November 10-12, 2026) on Tuesday, November 10, 2026, at 2:00 p.m. ET (8:00 p.m. CET), with a live webcast and a replay to follow. Members of the executive team will represent the company; an investor conference appearance, not a data release. | Confirmed date | Primary source |
| 2026-11-10 | $SENS | Senseonics Holdings, Inc. | Senseonics fireside chat at the Stifel 2026 Healthcare Conference (New York, November 10-12, 2026) on Tuesday, November 10, 2026, at 3:20 p.m. ET, with live webcast and one-on-one meetings. An investor conference appearance, not a data release. | Confirmed date | Primary source |
| 2026-11-10 | $SRRK | Scholar Rock Holding Corporation | Third-quarter 2026 financial results before the market open on Tuesday, November 10, 2026, followed by a conference call and webcast at 8:00 a.m. ET. | Confirmed date | Finviz (news) |
| 2026-11-10 | $TLSI | TriSalus Life Sciences, Inc. | Third-quarter 2026 financial results: conference call and webcast on Tuesday, November 10, 2026, at 8:30 a.m. ET; a press release with the results will be issued before the call. | Confirmed date | Finviz (news) |
| 2026-11-11 | $SENS | Senseonics Holdings, Inc. | Senseonics presentation at the 20th Annual Canaccord Genuity MedTech, Diagnostics & Digital Health Forum (New York) on Wednesday, November 11, 2026, at 10:30 a.m. ET, with live webcast and one-on-one meetings. An investor conference appearance, not a data release. | Confirmed date | Primary source |
| 2026-11-11 | $TEVA | Teva Pharmaceutical Industries Ltd. | Teva R&D Day in New York on November 11, 2026, 8:30 a.m. to 12:30 p.m. ET: leadership to discuss the R&D pipeline and near-term value-creation potential over the next five years. Live webcast on the investor relations site. | Confirmed date | Primary source Supporting source |
| 2026-11-12 | $LBRX | LB Pharmaceuticals Inc. | Stifel Healthcare Conference (New York, NY): fireside chat at 9:20 a.m. ET and one-on-one investor meetings on Thursday, November 12, 2026. Webcast on the company investor website. An investor conference appearance, not a data release. | Confirmed date | Primary source |
| 2026-11-13 | $DRTS | Alpha Tau Medical LTD. | Society for Neuro-Oncology (SNO) 2026 Annual Meeting (Philadelphia), Friday, November 13, 2026, 7:30–9:30 p.m. ET: presentation of the safety interim analysis of REGAIN (NCT06910306), the U.S. study of Alpha DaRT in recurrent glioblastoma, including new trial data that build on the interim results announced on May 11, 2026 from the first three treated patients. | Confirmed date | SEC filing Supporting source |
| 2026-11-13 | $EPRX | Eupraxia Pharmaceuticals Inc. | Virtual Analyst Day to discuss EP-104GI for eosinophilic esophagitis on November 13, 2026, at 8:30 a.m. ET, with webcast. | Confirmed date | Primary source |
| 2026-11-13 | $ZLAB | Zai Lab Limited | ACAAI 2026 (Phoenix): first clinical data for ZL-1503, an IL-13/IL-31R bispecific antibody, from the healthy-volunteer study NCT07235384 as ePoster R376 on November 13, 2026 at 2:50 p.m. MT (4:50 p.m. ET); Zai Lab conference call the same day at 8:00 a.m. ET. Healthy-volunteer pharmacokinetics, biomarkers and initial safety, not patient efficacy. | Confirmed date | Primary source |
| 2026-11-15 | $AMLX | Amylyx Pharmaceuticals, Inc. | ObesityWeek presentation of Phase 3 LUCIDITY in post-bariatric hypoglycemia, 08:30–08:45 ET. Topline was previously announced in August; this is the scientific presentation. | Confirmed date | Primary source |
| 2026-11-15 | $CRBP | Corbus Pharmaceuticals Holdings, Inc. | Late-breaking poster at ObesityWeek 2026 (National Harbor, MD, November 14-17): efficacy, safety and tolerability of CRB-913 in the Phase 1b CANYON-1 study, November 15, 2026, 2:30-3:30 p.m. ET, Gaylord National Resort & Convention Center, Exhibit Hall BCD. | Confirmed date | Primary source |
| 2026-11-15 | $GPCR | Structure Therapeutics Inc. | Conference presentation: aleniglipron (oral small-molecule GLP-1 receptor agonist) · overweight and obesity. Two posters at ObesityWeek 2026 (National Harbor, MD, November 14-17): ACCESS trial open-label extension, and dose-ranging effects across the ACCESS trials. Both on November 15, 2026, 2:30-3:30 p.m. ET. Congress: ObesityWeek 2026. | Confirmed date | Primary source |
| 2026-11-16 | $EPRX | Eupraxia Pharmaceuticals Inc. | Eupraxia presentation at the 2026 Jefferies Global Healthcare Conference in London (November 16-19, 2026) on November 16, 2026, at 1:30 p.m. GMT, with webcast and one-on-one meetings. An investor conference appearance, not a data release. | Confirmed date | Primary source |
| 2026-11-16 | $GENB | GENERATE BIOMEDICINES INC | Presentation at the Jefferies Global Healthcare Conference in London on Monday, November 16, 2026, at 10:30 a.m. ET, with live webcast. An investor conference appearance, not a data release. | Confirmed date | Primary source |
| 2026-11-19 | $ANVS | Annovis Bio, Inc. | CTAD 2026 (Boston, November 16-19): oral communication on buntanetap in Alzheimer's disease, Biotech Showcase 7, November 19, 2026, 3:52 p.m. ET. Two posters are on display November 16, 2:00 p.m. to November 17, 5:30 p.m. ET: P025 on the trial design and baseline characteristics of the pivotal Phase 3 study in early Alzheimer's disease, and P121 on AI-based prediction of blood-brain barrier permeability. The company expects the pivotal data readout in early 2027. | Confirmed date | Primary source |
| 2026-11-19 | $INBX | INHIBRX BIOSCIENCES INC | 2026 Connective Tissue Oncology Society (CTOS) Annual Meeting (Seoul, South Korea), Thursday, November 19, 2026, 5:30-6:30 PM KST: poster presentation (lead author Varun Monga) of the Phase 1/2 study of the tetravalent death receptor 5 (DR5) agonist ozekibart (INBRX-109) combined with irinotecan and temozolomide in adolescents and adults with Ewing sarcoma. | Confirmed date | Primary source |
| 2026-11-20 | $INBX | INHIBRX BIOSCIENCES INC | 2026 Connective Tissue Oncology Society (CTOS) Annual Meeting (Seoul, South Korea), Friday, November 20, 2026, 11:00 AM-12:30 PM KST: oral presentation (lead author Sant Chawla) of subgroup analysis and updated progression-free survival (PFS) from the randomized, Phase 2 ChonDRAgon study of the tetravalent death receptor 5 agonist ozekibart (INBRX-109) in conventional chondrosarcoma. | Confirmed date | Primary source |
| 2026-12-08 | $OCS | Oculis Holding AG | Oculis R&D Day on December 8, 2026, with updates on the late-stage pipeline, including privosegtor and licaminlimab. | Confirmed date | Primary source |
| 2026-12-14 | $MBOT | Microbot Medical Inc. | 2026 annual meeting of stockholders on Monday, December 14, 2026, set by the Board of Directors on October 14, 2026. Record date: October 15, 2026. The exact time and location will be specified in the proxy statement for the meeting. | Confirmed date | SEC filing |
| 2026-12-22 | $OCGN | Ocugen, Inc. | Postponed special meeting of stockholders on the proposal to increase authorized common stock by 250,000,000 shares: Tuesday, December 22, 2026, 8:00 a.m. ET, virtual. Record date: close of business October 30, 2026. The meeting had previously been adjourned to October 26, 2026; the board postponed it on October 14, 2026. | Confirmed date | SEC filing |
Conferences with a confirmed range: 20 events
The range refers to the conference dates. Any confirmed individual presentation day is stated in the row; other presentation days are not inferred from the conference start.
| Date / window | Ticker | Company | Event | Status | Sources |
|---|---|---|---|---|---|
| October 22–23, 2026 | $CLYM | Climb Bio, Inc. | ASN CLYM116 Phase 1 poster October 22 and MIL116 preliminary Phase 1 healthy-volunteer poster October 23. Refines the prior Q4 clinical-data package. | Conference range | Primary source |
| October 21–23, 2026; ePoster day unspecified | $ZBIO | Zenas BioPharma, Inc. | MSToronto ePoster EP2593: pharmacokinetic analysis from the Phase 2 RRMS study. Distinct from the October 22 efficacy poster; no exact ePoster day is disclosed. | Conference range | Primary source Supporting source |
| October 21–25, 2026 | $MLYS | Mineralys Therapeutics, Inc. | ASN Launch-HTN analysis of blood pressure and albuminuria in CKD stages 1–3. Conference window October 21–25; individual presentation day not provided in the company release. | Conference range | Primary source MLYS stock hub |
| October 21–25, 2026 | $TVTX | Travere Therapeutics, Inc. | ASN Kidney Week package includes SPARTAN two-year IgAN data, post hoc DUPLEX FSGS analysis and PROTECT biomarker analyses. Conference dates are a package window, not the time of one session; results described in the October 2 release. | Conference range | Primary source |
| ESMO Congress 2026-10-23–2026-10-27 | $BHVN | BIOHAVEN LTD | Conference presentation: BHV-1530 · Advanced solid tumors (Phase 1). Company timing: ESMO Congress, October 23–27, 2026. Congress: ESMO Congress. The conference range does not establish the individual presentation day. | Conference range | Primary source Supporting source |
| ESMO Congress 2026-10-23–2026-10-27 | $GENB | GENERATE BIOMEDICINES INC | Conference presentation: GB-4362 · locally advanced or metastatic urothelial cancer (Phase 1). Company timing: ESMO Congress, October 23–27, 2026. Congress: ESMO Congress. The conference range does not establish the individual presentation day. | Conference range | Primary source Supporting source |
| ESMO Congress 2026-10-23–2026-10-27 | $HCM | HUTCHMED (CHINA) LTD | Conference presentation: ORPATHYS (savolitinib) plus TAGRISSO (osimertinib). Company timing: ESMO Congress, October 23–27, 2026. Congress: ESMO Congress. The conference range does not establish the individual presentation day. | Conference range | Primary source Supporting source |
| ESMO Congress 2026-10-23–2026-10-27 | $HCM | HUTCHMED (CHINA) LTD | SANOVO Phase III savolitinib plus osimertinib results selected for an oral Proffered Paper presentation at ESMO. Separate from the SAFFRON Presidential Symposium presentation. Company timing: ESMO Congress, October 23–27, 2026. The congress dates do not establish the individual presentation day. | Conference range | Primary source Supporting source |
| ESMO Congress 2026-10-23–2026-10-27 | $IDYA | IDEAYA BIOSCIENCES INC | Conference presentation: IDE849 (DLL3 TOP1i ADC) · small-cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC) (Phase 1). Company timing: ESMO Congress, October 23–27, 2026. Congress: ESMO Congress. The conference range does not establish the individual presentation day. | Conference range | Primary source Supporting source |
| ESMO Congress 2026-10-23–2026-10-27 | $IDYA | IDEAYA BIOSCIENCES INC | Conference presentation: darovasertib combination (Phase 2). Company timing: ESMO Congress, October 23–27, 2026. Congress: ESMO Congress. The conference range does not establish the individual presentation day. | Conference range | Primary source Supporting source |
| ESMO Congress 2026-10-23–2026-10-27 | $IDYA | IDEAYA BIOSCIENCES INC | Conference presentation: darovasertib · Primary uveal melanoma; Metastatic uveal melanoma. Company timing: ESMO Congress, October 23–27, 2026. Congress: ESMO Congress. The conference range does not establish the individual presentation day. | Conference range | Primary source Supporting source |
| ESMO Congress 2026-10-23–2026-10-27 | $ONCY | Oncolytics Biotech Inc. | ESMO Congress 2026 (October 23–27, 2026): trial-in-progress e-poster (presentation number 994eTiP) on REO 033, a randomized Phase 2 study of pelareorep plus FOLFIRI and bevacizumab versus FOLFIRI and bevacizumab alone as second-line treatment for RAS-mutated, microsatellite-stable metastatic colorectal cancer (30 patients per arm; primary endpoint objective response rate). The company has not announced the day of the e-poster within the congress dates. | Conference range | SEC filing SEC filing Supporting source |
| ESMO Congress 2026-10-23–2026-10-27 | $ORIC | ORIC PHARMACEUTICALS INC | Conference presentation: enozertinib · 1L NSCLC with EGFR atypical mutations. Company timing: ESMO Congress, October 23–27, 2026. The congress dates do not establish the individual presentation day. | Conference range | Primary source Supporting source |
| ESMO Congress 2026-10-23–2026-10-27 | $XNCR | XENCOR INC | Conference presentation: XmAb819 · Clear cell renal cell carcinoma (RCC) (Phase 1). Company timing: ESMO Congress, October 23–27, 2026. Congress: ESMO Congress. The conference range does not establish the individual presentation day. | Conference range | Primary source Supporting source |
| CTAD 2026, Nov 16-17, 2026 | $ABOS | Acumen Pharmaceuticals, Inc. | Three posters at the 19th Clinical Trials on Alzheimer's Disease (CTAD) conference in Boston (November 16-19, 2026), Poster Session 1, Monday, November 16, 2:00 p.m. to Tuesday, November 17, 5:30 p.m. EST: P015 on baseline characteristics of participants randomized in the Phase 2 ALTITUDE-AD trial of sabirnetug in early Alzheimer's disease, and P023 and P024 on treatment expectations, trial participation and care-partner experiences. No new efficacy results are announced. | Conference range | Primary source |
| November 16-19, 2026 conference; presentation day unspecified | $ACAD | Acadia Pharmaceuticals Inc. | RADIANT Phase 2 remlifanserin detailed safety and efficacy oral presentation at CTAD, confirmed for the November 16–19, 2026 conference; the presentation day has not been specified. The primary endpoint was not statistically met. | Conference range | Primary source Supporting source |
| Nov 16-19, 2026 | $IPHA | Innate Pharma S.A. | Innate Pharma will participate in the Jefferies Global Healthcare Conference (London, November 16-19, 2026); the company's press release does not specify the day, time, or format of its appearance. An investor conference appearance, not a data release. | Conference range | Primary source |
| Signed Oct 19, 2026; closing expected by Feb 19, 2027 (HSR clearance pending) | $MYGN | Myriad Genetics, Inc. | Myriad Genetics signed an Asset Purchase Agreement, dated October 19, 2026, to sell its prenatal health business — the Foresight Carrier Screen, Prequel Prenatal Screen, FirstGene 4-in-1 Prenatal Screen (an LDT), and the SneakPeek Early Gender Test — to Laboratory Corporation of America Holdings (LabCorp), for $210 million in cash plus the value of the business's inventory at closing. LabCorp owes a $10.5 million termination fee under specified circumstances tied to regulatory approvals. The agreement's outside date is February 19, 2027, automatically extended to October 19, 2027 if only regulatory clearances (including under the Hart-Scott-Rodino Act) remain outstanding. Closing is also expected to include a patent license agreement with a LabCorp affiliate and a transition services agreement; LabCorp will offer employment to affected employees on comparable terms. | Conference range | SEC filing |
| Q1 2027 | $BHVN | Biohaven Ltd. | FDA accepted for review the resubmitted NDA for VYGLXIA (troriluzole) for spinocerebellar ataxia (SCA); the resubmission included new positive supportive analyses. The FDA considers it a complete response to the November 4, 2025 action letter and assigned a user fee goal date in the first quarter of 2027. The FDA plans to convene a meeting of the Peripheral and Central Nervous System Advisory Committee; the meeting date has not yet been announced. The PDUFA target action date is a goal and does not assure approval. | Conference range | SEC filing |
| Q1 2027 | $CRMD | CorMedix Therapeutics | FDA accepts for Priority Review the supplemental NDA for REZZAYO (rezafungin for injection) for prophylaxis of invasive fungal disease in adults undergoing allogeneic hematopoietic stem cell transplantation, based on the Phase 3 ReSPECT trial. PDUFA target action date in Q1 2027. Partner: Mundipharma. | Conference range | SEC filing SEC filing |
Company windows and explicit estimates: 544 events
Quarters, half-years and other windows are company guidance, not exact dates. Estimates derived from a regulatory review duration are labeled as calculated. A window-end marker is not an announced readout day. Filings, study starts and results are different milestones.
| Date / window | Ticker | Company | Event | Status | Sources |
|---|---|---|---|---|---|
| October 2026 | $IVVD | Invivyd, Inc. | VYD2311 DECLARATION placebo-controlled safety and neutralizing-antiviral-titer topline expected in October 2026. Clinical efficacy events remain blinded and a BLA is only planned, subject to supportive data. | Estimated window | Primary source |
| October 2026 | $MIRM | Mirum Pharmaceuticals / Incyte | Atebrioz US commercial launch expected October 2026; exact day not announced. Estimated window: October 2026. | Estimated window | Primary source |
| October 2026 | $TLSA | Tiziana Life Sciences Ltd. | INFORM-MS foralumab 12-week topline. Estimated window: October 2026. Exact event day is not announced. | Estimated window | Primary source |
| Around November 1, 2026 (calculated) | $QURE | uniQure N.V. | AMT-130 BLA filing-review decision window. Estimated: around November 1, 2026 (calculated). November 1 is calculated from 60 calendar days after the September 2 submission; the issuer did not announce an exact decision day. Priority review was requested, not granted. This is not a PDUFA deadline. | Estimated window | Primary source |
| ACAAI Annual Scientific Meeting 2026-11-12–2026-11-16 | $ADMA | ADMA BIOLOGICS INC | ASCENIV real-world outcomes abstract submitted to ACAAI. Acceptance and an individual presentation date are not confirmed by the cited release. Company timing: ACAAI Annual Scientific Meeting, November 12–16, 2026. Exact event day is not announced. Congress: ACAAI Annual Scientific Meeting. The conference range does not establish the individual presentation day. | Estimated window | Primary source Supporting source |
| 17 October–16 November 2026 | $RARE | Ultragenyx Pharmaceutical Inc. | FAYUVI commercial product expected available to ship to qualified treatment centers within 30-60 days of September 17 approval: October 17-November 16, 2026. | Estimated window | Primary source |
| September–November 2026 | $ACAD | ACADIA PHARMACEUTICALS INC | Topline data: DAYBUE (trofinetide) · Rett syndrome (RTT). Company timing: September–November 2026. Exact event day is not announced. | Estimated window | Primary source |
| November 2026 | $CRVO | CervoMed Inc. | CervoMed plans to present 24-week nfvPPA biomarker data at CTAD in November 2026. The October 12 release does not specify the presentation day. | Estimated window | Primary source |
| November 2026 | $IBRX | IMMUNITYBIO, INC. | QUILT-2.005 cohort A, registrational trial of ANKTIVA plus BCG versus BCG alone in BCG-naive non-muscle-invasive bladder cancer (366 patients randomized): database lock announced October 21, 2026; final analysis of the primary endpoint and key secondary endpoints underway, topline results expected in November 2026. Exact day not announced. | Estimated window | Primary source |
| November 2026 | $PHAR | Pharming Group N.V. | Leniolisib: topline Phase II results from the trial in CVID patients with immune dysregulation, with or without an identified genetic cause, expected in November 2026 according to the company. Pharming is working towards a single registrational Phase III trial in the broader CVID indication. Exact day not announced. | Estimated window | Primary source |
| November 2026 | $RHHBY | Roche Holding AG | Gazyva/Gazyvaro (obinutuzumab): FDA decision window in primary membranous nephropathy. Estimated window: November 2026. Priority Review is confirmed, but the issuer states November, not a specific day. | Estimated window | Primary source |
| Late November 2026 | $SLGL | Sol-Gel Technologies Ltd. | SGT-610 (patidegib gel 2%), pivotal Phase 3 in Gorlin syndrome. September 17 company update reports last patient last visit and expects topline results in late November 2026. Registry completion is a separate milestone. | Estimated window | Primary source |
| Early November 2026 | $SXTP | 60 Degrees Pharmaceuticals, Inc. | Additional screening data from expanded access in refractory babesiosis expected early November 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| 2026 | $AAPG | ASCENTAGE PHARMA GROUP INTERNATIONAL | Initial data: APG-3288 (Phase 1). Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $ABCL | ABCELLERA BIOLOGICS INC | Topline data: ABCL575 (Phase 1). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $ABOS | Acumen Pharmaceuticals, Inc. | Topline results from ALTITUDE-AD (NCT06335173), the Phase 2 trial of sabirnetug administered every four weeks in early Alzheimer's disease, which enrolled 542 participants, expected in late 2026 according to the company. Exact day not announced. | Estimated window | Primary source |
| H2 2026 | $ABSI | ABSCI CORP | Interim data: ABS-201 · PHL. Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $ABVX | ABIVAX SA | NDA/BLA submission: obefazimod · Ulcerative colitis (UC) (Phase 3). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| By year-end 2026 | $ADMA | ADMA BIOLOGICS INC | FDA meeting: SG-001 · Streptococcus pneumoniae infection. Company timing: By year-end 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $AGIO | AGIOS PHARMACEUTICALS INC | Topline data: tebapivat · sickle cell disease (SCD) (Phase 2). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $AGIO | AGIOS PHARMACEUTICALS INC | Initial data: AG-181 · Phenylketonuria (PKU) (Phase 1b). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $ALKS | ALKERMES PLC | NDA/BLA submission: LUMRYZ (sodium oxybate) · Idiopathic hypersomnia (Phase 3). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $ALKS | ALKERMES PLC | Topline data: alixorexton · Idiopathic hypersomnia (phase 2). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $ALMS | Alumis Inc. | Envudeucitinib NDA for moderate-to-severe plaque psoriasis planned for Q4 2026. Company guidance; not yet a submitted or accepted filing. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $ALNY | Alnylam Pharmaceuticals, Inc. | ALN-6400 Phase 1/2 and ALN-2232 Phase 1 readouts expected H2 2026; October 1 is an indicative placement, not an announced clinical date. | Estimated window | Primary source |
| Late 2026 | $ALVO | ALVOTECH | Potential regulatory decision (company forecast): Biologics License Applications. Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $ALVO | ALVOTECH | Regulatory decision: relevant BLAs. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $AMLX | AMYLYX PHARMACEUTICALS INC | NDA/BLA submission: avexitide · Post-bariatric hypoglycemia. Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| By year-end 2026 | $ARCT | Arcturus Therapeutics Holdings Inc. | ARCT-2601 integration into the ongoing OTC-deficiency Phase 2 study. Estimated: by year-end 2026. Company plan following the September 23 ARCT-810 interim announcement; regulatory and operational execution remain prospective. | Estimated window | Primary source |
| Q4 2026 | $ARQT | ARCUTIS BIOTHERAPEUTICS INC | Clinical data readout: ZORYVE foam 0.3% · Vitiligo (Phase 2). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| By year-end 2026 | $ARWR | ARROWHEAD PHARMACEUTICALS INC | Plozasiran sNDA for severe hypertriglyceridemia targeted by year-end 2026. Entry into the FDA STAR pilot was announced on October 7; this does not imply a completed submission, an acceptance or an FDA decision date. Exact event day is not announced. | Estimated window | Primary source Supporting source |
| Q4 2026 | $ATAI | ATAIBECKLEY INC | Initial data: BPL-003 · treatment-resistant depression (TRD) (Phase 2a). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $ATAI | ATAIBECKLEY INC | Topline data: VLS-01 · TRD (Phase 2). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $AVBP | ARRIVENT BIOPHARMA INC | ARR-217 Phase 1 dose-escalation completion and transition to dose optimization. No interim-results publication is promised by this milestone. Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $AXSM | AXSOME THERAPEUTICS INC | Topline data: solriamfetol · Binge eating disorder ENGAGE (Phase 3). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $BBIO | BridgeBio Pharma, Inc. | Submission of the achondroplasia marketing authorization application to EMA planned Q4 2026; company guidance, not an EMA decision date. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $BCAX | BICARA THERAPEUTICS INC | Initial data: ficerafusp alfa · 3L+ mCRC (RAS/BRAF wild type MSS); mCRC (RAS/BRAF wild type MSS) (Phase 1b). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| by end of 2026 | $BCRX | BioCryst Pharmaceuticals, Inc. | BCX17725 Phase 1 Part 4 data in Netherton syndrome. Estimated: by end of 2026. Up to 12 patients followed for three months; no exact release day. | Estimated window | Primary source |
| 2026 | $BEAM | BEAM THERAPEUTICS INC | Full data: BEAM-302 · Alpha-1 antitrypsin deficiency (AATD). Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $BEAM | BEAM THERAPEUTICS INC | Clinical data readout: ristoglogene autogetemcel (risto-cel) · sickle cell disease (SCD), BEACON (Phase 1/2). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $BHVN | BIOHAVEN LTD | Topline data: opakalim · Focal epilepsy (pivotal). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $BHVN | BIOHAVEN LTD | Topline data: taldefgrobep alfa · Obesity (Phase 2). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $BIOA | BioAge Labs, Inc. | QUELL-CV BGE-102 Phase 2 topline in cardiovascular risk. Estimated: H2 2026. Enrollment completed; timing guidance reaffirmed September 8. Exact event day is not announced. | Estimated window | Primary source Supporting source |
| Q4 2026 | $CELC | CELCUITY INC | Clinical data readout: REVTORPYK (gedatolisib) · Metastatic castration-resistant prostate cancer (Phase 2). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| December 2026 | $CGEM | Cullinan Therapeutics, Inc. | CLN-049: updated Phase 1 dose-escalation data with longer follow-up in relapsed/refractory acute myeloid leukemia, expected in December 2026. Exact event day is not announced. | Estimated window | Primary source |
| By year-end 2026 | $CGEM | Cullinan Therapeutics, Inc. | Completion of first-line zipalertinib-plus-chemotherapy RTOR NDA submission expected by year-end 2026; filing completion, not FDA acceptance or approval. Exact event day is not announced. | Estimated window | Primary source |
| December 2026 | $CGEM | Cullinan Therapeutics, Inc. | CLN-978: concurrent multidose and single-target-dose clinical data in systemic lupus erythematosus, rheumatoid arthritis and Sjögren's disease, expected in December 2026. One planned package across three indications. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $CGON | CG ONCOLOGY INC | BOND-003 Cohort P durability data in high-risk BCG-unresponsive Ta/T1 non-muscle-invasive bladder cancer without carcinoma in situ. Cohort C and CORE-008 Cohort A data are represented separately. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $CGON | CG ONCOLOGY INC | NDA/BLA submission: cretostimogene · HR BCG-unresponsive NMIBC. Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $CLDX | CELLDEX THERAPEUTICS INC | Topline data: barzolvolimab · Atopic dermatitis (AtD) (Phase 2). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $COGT | COGENT BIOSCIENCES INC | IND submission: CGT1145. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source COGT stock hub |
| 2026 | $COGT | COGENT BIOSCIENCES INC | Initial data: CGT4859 (Phase 1). Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source COGT stock hub |
| 2026 | $COGT | COGENT BIOSCIENCES INC | IND submission: CGT1815 · Cancer. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source COGT stock hub |
| Late 2026 | $COGT | COGENT BIOSCIENCES INC | Preliminary results from the SUMMIT extension cohort switching patients from avapritinib to bezuclastinib. Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source COGT stock hub |
| H2 2026 | $CRSP | CRISPR THERAPEUTICS AG | Clinical data readout: CTX611 (SRSD107) · Thromboembolic and clotting-related indications (Phase 2). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $CRSP | CRISPR THERAPEUTICS AG | Clinical data readout: zugocabtagene geleucel (zugo-cel; formerly CTX112™) · B-cell malignancies; systemic lupus erythematosus (SLE), systemic sclerosis, inflammatory myositis, immune thrombocytopenic purpura, and warm autoimmune hemolytic anemia (Phase 1/2). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $CRSP | CRISPR THERAPEUTICS AG | Preclinical program update: CTX321™ · elevated lipoprotein(a) [Lp(a)]. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $CRVO | CervoMed Inc. | First dosing with neflamapimod in EXPERTS-ALS Phase 2a is expected in Q4 2026. Company guidance; dosing has not been confirmed by this announcement. | Estimated window | Primary source |
| Q4 2026 | $CYTK | CYTOKINETICS INC | NDA/BLA submission: MYQORZO (aficamten) · symptomatic nHCM (Phase 3). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $DFTX | DEFINIUM THERAPEUTICS INC | Initial data: MM402 (R(-)-MDMA) · Autism Spectrum Disorder (Phase 2a). Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $DFTX | Definium Therapeutics | DT120 ODT — pre-NDA meeting scheduled in Q4 2026. December 31 is the conventional end of the October–December window, not the exact meeting date. | Estimated window | Primary source |
| H2 2026 | $DMRA | DAMORA THERAPEUTICS INC | IND submission: DMR-002. Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $DMRA | DAMORA THERAPEUTICS INC | Regulatory submissions to expand the Phase 1/1b DMR-001 trial globally in essential thrombocythemia and myelofibrosis. These are trial authorizations, not marketing applications. Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| December 2026 | $DNTH | DIANTHUS THERAPEUTICS INC | Topline data: claseprubart · Multifocal motor neuropathy (Phase 2). Company timing: December 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $DNTH | DIANTHUS THERAPEUTICS INC | Initial data: DNTH212 · systemic lupus erythematosus (SLE) (Phase 1). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $DRTS | ALPHA TAU MEDICAL LTD | PMA submission: Alpha DaRT · cutaneous squamous cell carcinoma ReSTART. Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Late 2026 | $DRTS | ALPHA TAU MEDICAL LTD | Interim data: Alpha DaRT · REGAIN, recurrent glioblastoma. Company timing: Late 2026 (last stated August 10, 2026: additional data expected around the end of 2026). On October 19, 2026 the company announced that the FDA approved an expansion of REGAIN from 10 to 20 patients and a protocol provision for an additional interim analysis six months after the fifth patient's treatment, which occurred in July 2026; no release date for that analysis was given. Exact event day is not announced. | Estimated window | SEC filing SEC filing |
| By year-end 2026 | $EDIT | Editas Medicine, Inc. | Editas expects to begin dosing EDIT-401 in the Phase 1/2 Strive HeFH trial by year-end 2026. Company guidance; no exact event day announced. | Estimated window | Primary source |
| Q4 2026 | $ELDN | Eledon Pharmaceuticals, Inc. | LEGACY Phase 3 kidney-transplant trial initiation. Estimated window: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| By year-end 2026 | $ELVN | Enliven Therapeutics, Inc. | Enliven says ENABLE-2 Phase 3 of relcobatinib (ELVN-001) in previously treated CML remains on track to initiate before year-end 2026 after FDA alignment on the trial design. Exact start day is not announced. | Estimated window | Primary source |
| December 2026 | $EPRX | Eupraxia Pharmaceuticals Inc. | RESOLVE Phase 2b interim data for EP-104GI in eosinophilic esophagitis expected in December 2026. Company guidance; no exact day announced. Separate from open-label Phase 1b/2a data being presented in October. | Estimated window | Primary source |
| H2 2026 | $ERAS | ERASCA INC | Initial data: ERAS-4001 · RAS-mutant solid tumors (Phase 1). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $ETON | ETON PHARMACEUTICALS INC | Topline data: ET-700 · Wilson disease. Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $ETON | ETON PHARMACEUTICALS INC | NDA/BLA submission: AMGLIDIA®. Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $EWTX | EDGEWISE THERAPEUTICS INC | GRAND CANYON pivotal cohort topline results in Becker muscular dystrophy. Servier acquired sevasemten and the muscular-dystrophy business in July 2026; Edgewise retains exposure through contingent milestone payments. Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| later in 2026 | $GOSS | Gossamer Bio, Inc. | FDA filing-acceptance review of seralutinib NDA. Estimated: later in 2026. The company expects this could occur later this year. No PDUFA date has been announced, and the timing is not guaranteed for Q4. | Estimated window | Primary source |
| Q4 2026 | $GPCR | STRUCTURE THERAPEUTICS INC | Results from the Phase 2 aleniglipron study in adults with type 2 diabetes and obesity or overweight. Separate from the 44-week body-composition study. Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Q4 2026 | $GPCR | STRUCTURE THERAPEUTICS INC | Results from the 44-week Phase 2 body-composition trial of aleniglipron, evaluating body fat and overall body composition. This is separate from the Phase 2 diabetes study. Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Q4 2026 | $GRFS | GRIFOLS SA | Topline data: alpha-1 antitrypsin · Emphysema SPARTA (Phase 3). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $HCM | HUTCHMED (CHINA) LTD | Clinical trial initiation: HMPL-A830 · Solid tumors. Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $HCM | HUTCHMED (CHINA) LTD | IND submission: ATTC candidates. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $HELP | Cybin Inc. doing business as Helus Pharma | HLP003 APPROACH Phase 3 pivotal study (adjunctive treatment of major depressive disorder, 223 participants enrolled): topline data readout on track for Q4 2026, as reiterated at the October 21, 2026 investor presentation. Exact day not announced. | Estimated window | Primary source |
| Q4 2026 | $HRMY | HARMONY BIOSCIENCES HOLDINGS INC | Topline data: BP-205 (Phase 1). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $HROW | HARROW INC | Topline data: NATACYN · fungal keratitis. Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $HROW | HARROW INC | Topline data: IHEEZO · patients undergoing intravitreal injections QUELL (Phase 4). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $HUMA | Humacyte, Inc. | Humacyte targets an FDA supplemental BLA for arteriovenous access for hemodialysis in Q4 2026. This is a planned submission, separate from the existing vascular-trauma approval. | Estimated window | Company release |
| Q4 2026 | $IBRX | IMMUNITYBIO, INC. | Planned sBLA submission to the FDA for ANKTIVA plus BCG in BCG-naive non-muscle-invasive bladder cancer, based on QUILT-2.005; the company said on October 21, 2026 that it remains on track for the fourth quarter of 2026. Exact day not announced. | Estimated window | Primary source |
| H2 2026 | $IDYA | IDEAYA BIOSCIENCES INC | NDA/BLA submission: darovasertib in combination with crizotinib · Metastatic uveal melanoma (registrational). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $IDYA | IDEAYA BIOSCIENCES INC | Conference presentation: IDE397 · MTAP-deleted urothelial cancer (UC) (Phase 1/2). Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $IMCR | IMMUNOCORE HOLDINGS PLC | Topline data: KIMMTRAK (tebentafusp) · previously treated advanced melanoma. Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $IMCR | IMMUNOCORE HOLDINGS PLC | IND submission: IMC-U120AI · atopic dermatitis (AtD); autoimmune candidate. Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $IMCR | IMMUNOCORE HOLDINGS PLC | Conference presentation: IMC-P115C · solid tumors; Multiple solid tumors (Phase 1). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $IMCR | IMMUNOCORE HOLDINGS PLC | Conference presentation: brenetafusp · solid tumors; ovarian and lung cancer (Phase 1/2). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $IMNM | IMMUNOME INC | IND submission: IM-1335. Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $IMNM | IMMUNOME INC | IND submission: solid tumor-targeted ADC programs · Solid tumors. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $IMNM | IMMUNOME INC | Initial data: IM-1021 · B-cell lymphoma (Phase 1). Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $IMNM | IMMUNOME INC | Marketing authorization application: varegacestat (formerly AL102). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $IMTX | IMMATICS NV | Initial data: IMA402 · melanoma and gynecologic cancers (Phase 1). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $IMTX | IMMATICS NV | Clinical data readout: IMA203CD8 · Gynecologic cancers (Phase 1). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Later in 2026 | $IMUX | Immunic, Inc. | Planned initiation of the Phase 3 program of vidofludimus calcium in progressive multiple sclerosis, which the company expects to initiate later this year (stated October 21, 2026). Exact day not announced. | Estimated window | Primary source |
| By year-end 2026 | $IMUX | Immunic, Inc. | Top-line results from the fully enrolled Phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis, expected by year-end 2026 (stated October 21, 2026). Exact day not announced. | Estimated window | Primary source |
| H2 2026 | $IMVT | IMMUNOVANT INC | Clinical program update: imeroprubart (IMVT-1402) · difficult-to-treat rheumatoid arthritis (RA) (potentially registrational). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| H2 2026 | $IMVT | IMMUNOVANT INC | Topline data: imeroprubart (IMVT-1402) · Cutaneous lupus erythematosus; rheumatoid arthritis (RA). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Q4 2026 | $INBX | INHIBRX BIOSCIENCES INC | FDA meeting: ozekibart (INBRX-109) · colorectal cancer (CRC) (Phase 1). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $IOVA | IOVANCE BIOTHERAPEUTICS INC | Conference presentation: Amtagvi (lifileucel) · metastatic non-squamous NSCLC. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $IOVA | IOVANCE BIOTHERAPEUTICS INC | Regulatory decision: Amtagvi (lifileucel) · Advanced melanoma. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $IPHA | Innate Pharma S.A. | PACIFIC-9 Phase 3 monalizumab readout. Estimated window: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $IRD | Opus Genetics, Inc. | Planned initiation of a Phase 1/2 trial of OPGx-RDH12, AAV gene therapy for RDH12-associated Leber congenital amaurosis, after FDA clearance of the IND announced October 21, 2026; the company plans to initiate the trial this quarter (Q4 2026). Exact day not announced. | Estimated window | Primary source |
| Late 2026 | $IRON | DISC MEDICINE INC | Initial data: DISC-3405 · sickle cell disease (SCD) (Phase 1b). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| By end of 2026 | $IRON | Disc Medicine, Inc. | Planned resubmission of the New Drug Application for bitopertin in erythropoietic protoporphyria (EPP) to the U.S. FDA by the end of 2026, based on the positive APOLLO Phase 3 results; the company anticipates an FDA decision by mid-2027. Company plan; no date announced. | Estimated window | Primary source SEC filing |
| Late 2026 | $IRON | DISC MEDICINE INC | FDA meeting: selcodebart (DISC-0974) · anemia of MF (Phase 2). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $IVA | Inventiva S.A. | NATiV3 Phase 3 lanifibranor topline in MASH. Estimated: Q4 2026. Last patient visit completed; exact readout day unannounced. | Estimated window | Primary source |
| 2026 | $JANX | JANUX THERAPEUTICS INC | Full data: JANX008 · Solid tumors (Phase 1). Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $JANX | Janux Therapeutics, Inc. | JANX011 Phase 1 initial clinical data in healthy volunteers. Estimated window: H2 2026. Exact event day is not announced. Healthy-volunteer data are not efficacy data in autoimmune patients. | Estimated window | Primary source |
| Q4 2026 | $KOD | Kodiak Sciences | Zenkuda multi-indication BLA submission planned. Estimated window: Q4 2026. Five positive Phase 3 studies across wet AMD, diabetic retinopathy and retinal vein occlusion. This is a planned submission, not an accepted filing, approval or PDUFA date. | Estimated window | Primary source |
| December 2026 | $KOD | Kodiak Sciences | KSI-101 PEAK Phase 3 Pivotal Analysis 1 topline in macular edema secondary to inflammation, first 300-patient cohort. Estimated window: December 2026. No exact release day; separate from registry primary completion and Pivotal Analysis 2. | Estimated window | Primary source Supporting source |
| Late 2026 | $KRYS | KRYSTAL BIOTECH INC | Interim data: KB407 · cystic fibrosis (CF) (Phase 1). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| H2 2026 | $KRYS | KRYSTAL BIOTECH INC | NDA/BLA submission: VYJUVEK (beremagene geperpavec) · Dystrophic Epidermolysis Bullosa. Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $KRYS | KRYSTAL BIOTECH INC | Topline data: beremagene geperpavec-svdt (KB803) · corneal abrasions in DEB patients (registrational). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Late 2026 | $KRYS | KRYSTAL BIOTECH INC | Topline data: KB801 · Neurotrophic keratitis (registrational). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Q4 2026 | $KRYS | KRYSTAL BIOTECH INC | FDA meeting: KB407 · cystic fibrosis (CF) (registrational). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Late 2026 | $KRYS | KRYSTAL BIOTECH INC | FDA meeting: KB111 · Hailey-Hailey disease (HHD). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $KRYS | KRYSTAL BIOTECH INC | Interim data: KB111 · Hailey-Hailey Disease. Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Late 2026 | $KYMR | KYMERA THERAPEUTICS INC | Topline data: KT-621 · Atopic dermatitis (AtD) (Phase 2b). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $KYMR | KYMERA THERAPEUTICS INC | Clinical data readout: KT-579 (Phase 1). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $KYTX | Kyverna Therapeutics, Inc. | miv-cel rolling BLA submission completion in SPS. Estimated window: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $LEGN | LEGEND BIOTECH CORP | Initial data: dual CD20/CD19-targeted cell therapy. Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $LGND | LIGAND PHARMACEUTICALS INC | NDA/BLA submission: Qtorin 3.9% rapamycin anhydrous gel (Qtorin rapamycin) · microcystic lymphatic malformations (microcystic LMs). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $LGND | LIGAND PHARMACEUTICALS INC | Topline data: ersodetug · Tumor hyperinsulinism (Phase 3). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| By year-end 2026 | $LPCN | Lipocine Inc. | Partner Verity plans Canadian TLANDO launch by year-end 2026 following Health Canada approval. Company guidance; no exact event day. | Estimated window | Primary source |
| 2026 | $LQDA | LIQUIDIA CORP | Planned completion of the ASCENT open-label study assessing 52 weeks of YUTREPIA treatment in pulmonary hypertension associated with interstitial lung disease. Completion is not an announced public data-release date. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| By year-end 2026 | $MAIA | MAIA Biotechnology, Inc. | THIO-104 Phase 3 in third-line NSCLC targets 100 patients enrolled and dosed by year-end 2026, versus 65 enrolled as disclosed October 7. This is an interim recruitment target, not full trial enrollment or results. Company guidance; no exact event day announced. | Estimated window | Primary source Trial registry |
| Later in 2026 | $MANE | VERADERMICS INC | Longer-term data from Part B of Phase 2/3 Study '302' of VDPHL01 in male pattern hair loss, extending the safety findings in men through 12 months, anticipated later in 2026. Company timing; no date announced. | Estimated window | Primary source SEC filing |
| Q4 2026 | $MBX | MBX BIOSCIENCES INC | First-cohort results from the 12-week multiple-ascending-dose portion of the Phase 1 MBX 4291 obesity trial. Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $MBX | MBX BIOSCIENCES INC | Conference presentation: MBX 6180. Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $MGTX | MEIRAGTX HOLDINGS PLC | IND submission: native human leptin (Ribo-Leptin) · Metabolic disease. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $MGTX | MEIRAGTX HOLDINGS PLC | NDA/BLA submission: botaretigene sparoparvovec · X-linked retinitis pigmentosa. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $MIRM | Mirum Pharmaceuticals, Inc. | Brelovitug AZURE-4, the second pivotal chronic hepatitis delta study, topline expected in Q4 2026. AZURE-1 results released on 28 September are a distinct study. | Estimated window | Primary source |
| By year-end 2026 | $MNKD | MANNKIND CORP | IND submission: Ralinepag DPI (MNKD-1501). Company timing: By year-end 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $NAMS | NEWAMSTERDAM PHARMA CO NV | Topline data: obicetrapib · type 2 diabetes (T2D) or metabolic syndrome (Phase 3). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $NBTX | NANOBIOTIX SA | Full data: NBTXR3 · NSCLC (Phase 2). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $NKTR | NEKTAR THERAPEUTICS | Conference presentation: NKTR-0165 (preclinical). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $NRIX | NURIX THERAPEUTICS INC | Conference presentation: bexobrutideg · Relapsed or refractory B-cell malignancies (Phase 1a/1b). Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| 2026 | $NRIX | NURIX THERAPEUTICS INC | IND submission: bexobrutideg · Autoimmune and inflammatory diseases (Phase 1). Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Late 2026 | $NUVB | NUVATION BIO INC | Preclinical drug-drug-conjugate platform update as Nuvation explores new candidates. No clinical patient-data release is specified. Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $NVCR | NOVOCURE LTD | Regulatory decision: TTFields therapy · brain metastases from non-small cell lung cancer (NSCLC). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| Around year-end 2026 | $OCS | Oculis Holding AG | PREDICT-1 registrational symptoms trial in genotype-selected TNFR1-mediated dry eye disease remains on track for topline around year-end. The October 8 Eyecelerator showcase is not this readout. Company guidance; exact event day is not announced. | Estimated window | Primary source Supporting source |
| Q4 2026 | $OCUL | Ocular Therapeutix, Inc. | AXPAXLI wet AMD NDA submission with interim SOL-R safety analysis. Estimated window: Q4 2026. Guidance reaffirmed after completed pre-NDA meeting. Submission is neither FDA acceptance nor approval. | Estimated window | Primary source |
| Q4 2026 | $ONCY | Oncolytics Biotech Inc. | GOBLET Cohort 4: final results of pelareorep with atezolizumab in second-line and later squamous cell anal carcinoma, expected in Q4 2026. Company guidance; no date announced. | Estimated window | SEC filing |
| Late 2026 | $OPK | OPKO HEALTH INC | IND submission: long-acting PTH tablet · Hypoparathyroidism. Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $ORIC | ORIC PHARMACEUTICALS INC | Initial data: enozertinib · 1L EGFR exon 20 insertion non-small cell lung cancer (NSCLC). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $ORIC | ORIC PHARMACEUTICALS INC | Rinzimetostat program update. The source does not specify an interim clinical-data release. Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $ORKA | Oruka Therapeutics, Inc. | ORKA-004: planned entry into clinical development of the extended-half-life anti-TL1A antibody in Q4 2026. Phase 2 combination studies are a separate future milestone. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $ORKA | Oruka Therapeutics, Inc. | EVERLAST-B ORKA-001 Week 16 data. Estimated window: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| December 2026 | $ORKA | Oruka Therapeutics, Inc. | EVERLAST-A ORKA-001 Week 52 data. Estimated window: December 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $OSTX | OS Therapies Incorporated | Company targets completion of BLA and conditional marketing authorization application submissions in Q4 2026. Phase 3 development remains necessary; filing targets do not establish approval. Exact event day is not announced. | Estimated window | Primary source |
| Around mid-Q4 2026 | $OSTX | OS Therapies Incorporated | OST-HER2 confirmatory Phase 3 initiation. Estimated window: around mid-Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $PBLS | PARABILIS MEDICINES INC | FDA meeting: zolucatetide · Desmoid tumors (Phase 3). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| By year-end 2026 | $PCRX | Pacira BioSciences, Inc. | Viatris/Pacira acquisition closing expected by year-end 2026, subject to tender of a majority of shares, expiration of the applicable regulatory waiting period and other customary conditions. Company guidance; no exact event day announced. | Estimated window | Primary source |
| Late 2026 | $PCRX | PACIRA BIOSCIENCES INC | Topline data: ZILRETTA · Osteoarthritis pain of the shoulder (Phase 3). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $PCRX | PACIRA BIOSCIENCES INC | Topline data: enekinragene inzadenovec (PCRX-201) · Osteoarthritis of the knee (Phase 2). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $PCRX | PACIRA BIOSCIENCES INC | NDA/BLA submission: EXPAREL. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $PCSA | Processa Pharmaceuticals, Inc. | VT7208 phase 2 initiation in peanut allergy planned for H2 2026. Company guidance in the October 5 SEC disclosure; the disclosure date is not necessarily the first announcement of this plan. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $PCSA | Processa Pharmaceuticals, Inc. | VT7208 phase 2 initiation in chronic spontaneous urticaria planned for H2 2026. Company guidance in the October 5 SEC disclosure; the disclosure date is not necessarily the first announcement of this plan. Exact event day is not announced. | Estimated window | Primary source |
| By year-end 2026 | $PGEN | PRECIGEN INC | PRGN-2009 pipeline update in HPV-driven cancers; the quoted guidance does not specify a clinical-data release. Company timing: By year-end 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $PRAX | Praxis Precision Medicines | Relutrigine EMERALD Phase 3 topline in broad developmental and epileptic encephalopathies. Estimated window: Q4 2026. Separate from the December 27 SCN2A/SCN8A PDUFA and registry completion dates. | Estimated window | Primary source |
| Q4 2026 | $PTCT | PTC THERAPEUTICS INC | Rolling NDA/BLA submission: ST-920 · Fabry disease (BLA-stage). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $PTCT | PTC THERAPEUTICS INC | FDA meeting: votoplam · Huntington's disease (HD) (Phase 3). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $PVLA | PALVELLA THERAPEUTICS INC | Palvella anticipates starting a Phase 2 trial of QTORIN pitavastatin in disseminated superficial actinic porokeratosis (DSAP) in Q4 2026. Company guidance; the October 12 release does not confirm initiation. | Estimated window | Company release |
| Q4 2026 | $QNCX | IRulya Therapeutics Inc. (formerly Quince Therapeutics) | LAM-001 Phase 2 study in sarcoidosis-associated pulmonary hypertension planned to initiate Q4 2026. Company guidance, not a confirmed day. IRulya is the current company name; QNCX changes to IRLA on October 12, 2026. | Estimated window | Primary source |
| Q4 2026 | $RAPP | RAPPORT THERAPEUTICS INC | Initial data: RAP-219 · focal onset seizures, long-term open-label extension of the Phase 2a trial (safety). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | SEC filing |
| Q4 2026 | $RARE | ULTRAGENYX PHARMACEUTICAL INC | Clinical data readout: rivunatpagene miziparvovec · Wilson disease Cyprus2+ (pivotal). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $REPL | REPLIMUNE GROUP INC | Full data: TUDRIQEV (vusolimogene oderparepvec-wtpg) · skin cancers, including cutaneous squamous cell carcinoma (CSCC), ARTACUS (Phase 1b/2). Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $REPL | REPLIMUNE GROUP INC | Initial data: RP2 (sturlimgene erparepvec) · hepatocellular carcinoma (HCC). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $RGNX | REGENXBIO Inc. | ATMOSPHERE and ASCENT pivotal surabgene lomparvovec topline in wet AMD. Estimated window: Q4 2026. Distinct from registry primary-completion dates. Exact release day is not announced. | Estimated window | Primary source |
| H2 2026 | $RHHBY | Roche Holding AG | Phase 2 petrelintide plus enicepatide (CT-388) combination trial planned to start H2 2026. Distinct from the already initiated petrelintide monotherapy Phase 3 program. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $RLAY | RELAY THERAPEUTICS INC | Zovegalisib: regulatory feedback to confirm the planned Phase 3 design in first-line endocrine-sensitive breast cancer, expected by year-end 2026. This is not a marketing-approval decision. Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $RLAY | RELAY THERAPEUTICS INC | Zovegalisib: clinical data and regulatory update for the vascular-anomalies program, expected by year-end 2026. Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $RXRX | RECURSION PHARMACEUTICALS INC | FDA meeting: REC-4881 · FAP. Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $RXRX | RECURSION PHARMACEUTICALS INC | Interim data: REC-1245 (Phase 1). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Mid-December 2026 | $RZLT | Rezolute, Inc. | Topline data from the open-label Phase 3 upLIFT study of ersodetug in tumor hyperinsulinism, expected mid-December 2026. The study is fully enrolled with 16 participants (announced October 14, 2026); 7 of the 8 participants in the first half met the primary endpoint responder criterion. Company guidance; no exact date announced. | Estimated window | SEC filing |
| 2026 | $SANA | Sana Biotechnology, Inc. | SC451 IND filing and Phase 1/2 trial start goal. Estimated window: 2026. Company goal, conditional on nonclinical, manufacturing and regulatory execution. This event does not set a date for SG293 data. | Estimated window | Primary source |
| Q4 2026 | $SCYX | SCYNEXIS, Inc. | SCY-770 Phase 2 proof-of-concept initiation. Estimated window: Q4 2026. Exact event day is not announced. | Estimated window | Primary source Supporting source |
| H2 2026 | $SENS | Senseonics Holdings, Inc. | Expected U.S. launch of the next-generation Eversense 365 mobile app developed with Welldoc during the second half of 2026, with availability in European markets early the following year. Exact day not announced. | Estimated window | Primary source |
| Q4 2026 | $SENS | Senseonics Holdings, Inc. | Planned commercial launch of the integrated Eversense 365 and iLet Bionic Pancreas system (Beta Bionics) following completion of integration activities in the fourth quarter of 2026, subject to required testing, validation activities and applicable regulatory requirements. Exact day not announced. | Estimated window | Primary source |
| Q4 2026 | $SLS | SELLAS LIFE SCIENCES GROUP INC | Topline data: tambiciclib · AML (Phase 2). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Q4 2026 | $SMMT | Summit Therapeutics Inc. | EA2251 (NCT07765433), registration-enabling open-label Phase II/III study sponsored and conducted by the ECOG-ACRIN Cancer Research Group: ivonescimab plus gemcitabine and cisplatin versus pembrolizumab or durvalumab plus gemcitabine and cisplatin in first-line advanced biliary tract cancer, primary endpoint overall survival. Activation of U.S. clinical trial sites is expected to begin in the fourth quarter of 2026. Exact day not announced. | Estimated window | Primary source |
| Late 2026 | $SNDX | SYNDAX PHARMACEUTICALS INC | IND submission: SNDX-4321 · non-small cell lung cancer (NSCLC). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $SNDX | SYNDAX PHARMACEUTICALS INC | Full data: Revuforj (revumenib) · NUP98r acute leukemia. Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $SNDX | SYNDAX PHARMACEUTICALS INC | Conference presentation: Revuforj (revumenib). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $SNDX | Syndax Pharmaceuticals, Inc. | Axatilimab plus ruxolitinib Phase 2 topline in newly diagnosed chronic GVHD. Estimated: Q4 2026. Distinct from the Phase 3 corticosteroid combination. Exact event day is not announced. | Estimated window | Primary source Supporting source |
| H2 2026 | $SRPT | SAREPTA THERAPEUTICS INC | SRP-1001: further multiple-ascending-dose data from the ongoing Phase 1/2 trial in facioscapulohumeral muscular dystrophy (FSHD), expected in H2 2026. These are early clinical results, with no precise release day announced. Company timing: H2 2026. | Estimated window | Primary source Supporting source |
| H2 2026 | $SRPT | SAREPTA THERAPEUTICS INC | SRP-1003: further multiple-ascending-dose data from the ongoing Phase 1/2 trial in myotonic dystrophy type 1 (DM1), expected in H2 2026. These are early clinical results, with no precise release day announced. | Estimated window | Primary source Supporting source |
| Late 2026 | $SRRK | SCHOLAR ROCK HOLDING CORP | Topline data: SRK-439 (Phase 1). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $SRZN | Surrozen | First patient dosing in DUET Phase 1b/2a for diabetic macular edema expected Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| By year-end 2026 | $STOK | Stoke Therapeutics, Inc. | Dosing of the third OSPREY cohort is expected to complete by year-end 2026. Dosing of the first two cohorts is complete; this is not the future clinical readout. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $SYRE | SPYRE THERAPEUTICS INC | Topline data: SPY072 · psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $TCRX | TScan Therapeutics, Inc. | ALLOHA Phase 1 Cohort C updated TSC-101 clinical data. Estimated window: Q4 2026. Data guidance maintained despite a pause in further Phase 3 ALLOHA-2 enrollment; this is not Phase 3 topline. | Estimated window | Primary source |
| H2 2026 | $TGTX | TG THERAPEUTICS INC | NDA/BLA submission: BRIUMVI (ublituximab-xiiy). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $TNGX | TANGO THERAPEUTICS INC | Initial data: TNG456 · glioblastoma (GBM). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $TNGX | TANGO THERAPEUTICS INC | Vopimetostat monotherapy data in lung cancer. Separate from the pancreatic-cancer combination data scheduled for ESMO. Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| By year-end 2026 | $TRDA | TRDA | ENTR-601-44: open-label follow-up from ELEVATE-44-201 Cohort 1 (6 mg/kg), assessing longer-term safety and functional measures in exon-44-skipping-amenable Duchenne muscular dystrophy, expected by year-end 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $TRDA | TRDA | VX-670: partner Vertex expects multiple-ascending-dose results from GALILEO Phase 1/2 in myotonic dystrophy type 1 in H2 2026, covering safety, muscle-biopsy splicing and preliminary functional measures. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $TRVI | TREVI THERAPEUTICS INC | LAKE Phase 2b refractory-chronic-cough study: sample-size re-estimation analysis after half the participants complete treatment. This is an operational interim analysis, not the final topline efficacy readout. Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $TTRX | Turn Therapeutics Inc. | GX-03 atopic dermatitis FDA Type B meeting planned in Q4 2026; not an approval or PDUFA date. Company guidance; no exact event day announced. | Estimated window | Primary source |
| 2026 | $TVTX | TRAVERE THERAPEUTICS INC | NDA/BLA submission: FILSPARI (sparsentan) · Japan. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $URGN | UROGEN PHARMA LTD | IND submission: UGN-501 · high-grade non-muscle invasive bladder cancer (NMIBC). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $VERA | Vera Therapeutics | TRUTAKNA full-approval sBLA submission planned Q4 2026. | Estimated window | Primary source |
| H2 2026 | $VIR | VIR BIOTECHNOLOGY INC | Interim data: VIR-5818 · Solid tumors (Phase 1). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $VIR | VIR BIOTECHNOLOGY INC | Topline data: elebsiran and tobevibart · Chronic hepatitis delta (HDV) (Phase 3). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| H2 2026 | $VRDN | VIRIDIAN THERAPEUTICS INC | Initial data: VRDN-008 (phase 1). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $VRDN | VIRIDIAN THERAPEUTICS INC | IND submission: anti-TSHR candidate · Graves' disease and TED. Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $VRDN | VIRIDIAN THERAPEUTICS INC | Development program update: VRDN-006. Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| By year-end 2026 | $VSTM | Verastem, Inc. | Planned opening of the TARGET-D 301 Phase 3 trial of VS-7375 (oral KRAS G12D ON/OFF inhibitor) in first-line metastatic pancreatic cancer by year-end 2026, after FDA alignment on the three-arm design (PFS and ORR dual primary endpoints). Company plan; no date announced. | Estimated window | SEC filing |
| By year-end 2026 | $VSTM | Verastem, Inc. | TARGET-D 101: mature data from the 900 mg VS-7375 plus anti-EGFR cohort in metastatic colorectal cancer and initial data from the 600 mg VS-7375 plus cetuximab cohort in metastatic pancreatic cancer, expected by year-end 2026. Company guidance; no date announced. | Estimated window | SEC filing |
| H2 2026 | $XNCR | XENCOR INC | Conference presentation: XmAb541 (CLDN6 x CD3) · Advanced gynecologic and germ cell tumors (Phase 1). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $XNCR | XENCOR INC | Clinical program update: XmAb657 (CD19 x CD3) · Idiopathic inflammatory myopathies (Phase 1). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $XNCR | XENCOR INC | Interim data: XmAb942 (Xtend TL1A) · Ulcerative colitis (UC) (Phase 2b). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $XNCR | XENCOR INC | NDA/BLA submission: obexelimab · Immunoglobulin G4-related disease. Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $XRTX | XORTX Therapeutics Inc. | XRx-026 gout IND submission. Estimated window: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| By year-end 2026 | $ZBIO | ZENAS BIOPHARMA INC | Initial data: ZB021 (Phase 1). Company timing: By year-end 2026. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 | $ZBIO | ZENAS BIOPHARMA INC | Topline data: obexelimab · systemic lupus erythematosus (SLE) (Phase 2). Company timing: Q4 2026. Exact event day is not announced. | Estimated window | Primary source |
| H2 2026 | $ZBIO | ZENAS BIOPHARMA INC | Marketing authorization application: obexelimab · Immunoglobulin G4-Related Disease (IgG4-RD). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 | $ZLAB | ZAI LAB LTD | IND submission: ZL-1311 (Phase 1). Company timing: Late 2026. Exact event day is not announced. | Estimated window | Primary source ZLAB stock hub |
| H2 2026 | $ZLAB | ZAI LAB LTD | Initial data: ZL-1503 (IL-13/IL-31R) · atopic dermatitis (AtD) (Phase 1/1b). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source ZLAB stock hub |
| By year-end 2026 | $ZURA | Zura Bio Limited | NEXUS-PMR: planned initiation by year-end 2026 of a Phase 2 study of tibulizumab in adults with polymyalgia rheumatica, the third indication selected for the program after FDA feedback. Company plan; no date announced. | Estimated window | SEC filing |
| Q4 2026 | $ZURA | Zura Bio Limited | TibuSHIELD: topline data from the Phase 2 study of tibulizumab, a bispecific antibody against IL-17 and BAFF, in adults with hidradenitis suppurativa, expected in Q4 2026. Enrollment is complete with 247 participants randomized. Company guidance; no date announced. | Estimated window | SEC filing |
| H2 2026 | $ZYME | ZYMEWORKS INC | Conference presentation: pasritamig · Advanced prostate cancer (Phase 1b). Company timing: H2 2026. Exact event day is not announced. | Estimated window | Primary source |
| 2026 | $ZYME | ZYMEWORKS INC | IND submission: ZW209 (Phase 1). Company timing: 2026. Exact event day is not announced. | Estimated window | Primary source |
| January 2027 | $SXTP | 60 Degrees Pharmaceuticals, Inc. | Company plans to request a pre-sNDA meeting in January 2027; this is a request target, not a confirmed meeting or an accepted application. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| January 2027 | $SXTP | 60 Degrees Pharmaceuticals, Inc. | Final primary and secondary endpoint data for the hospitalized-babesiosis study expected January 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| February 2027 | $ANAB | ANAPTYSBIO INC | PDUFA: Jemperli (dostarlimab) · Untreated stage II/III dMMR/MSI-H locally advanced rectal cancer, AZUR-1 (pivotal). Company timing: February 2027. Exact event day is not announced. FDA target action date; approval is not assured. | Estimated window | Primary source ANAB stock hub |
| February 2027 | $GSK | GSK / AnaptysBio | Jemperli rectal-cancer FDA action target communicated as February 2027 only; potential earlier review through National Priority Voucher. Exact day not disclosed. Estimated window: February 2027. | Estimated window | Primary source |
| Early 2027 | $ACIU | AC Immune SA | FDA discussions on the future development path and Part 2 design of VacSYn, the Phase 2 trial of ACI-7104 in early Parkinson's disease. Estimated window: early 2027. No meeting date has been announced. This event does not concern ACI-24.060 or ABATE. | Estimated window | Primary source Supporting source |
| Q1 2027 | $AEMD | Aethlon Medical, Inc. | NOR-101 Phase 1a start, proposed merger. Estimated window: Q1 2027. Exact event day is not announced. Aethlon/North merger is proposed and conditional; NRTX is only a proposed future ticker. | Estimated window | Primary source |
| Q4 2026 or Q1 2027 | $ANAB | AnaptysBio / GSK | Jemperli litigation judgment anticipated Q4 2026 or Q1 2027; exact day unknown. | Estimated window | Primary source ANAB stock hub |
| Q1 2027 | $ATYR | aTyr Pharma, Inc. | EFZO-CONNECT efzofitimod Phase 2 topline in systemic sclerosis-related ILD. Estimated window: Q1 2027. Exact event day is not announced. The September 24 update addresses the sarcoidosis protocol and does not replace this SSc-ILD readout guidance. | Estimated window | Primary source Supporting source |
| Q1 2027 | $BMEA | Biomea Fusion, Inc. | COVALENT-211 Phase 2 icovamenib Week 26 primary-endpoint topline in type 2 diabetes. Estimated: Q1 2027. Enrollment completed; the company readout guidance is separate from the registry primary completion date. | Estimated window | Primary source |
| Q1 2027 | $CRVO | CervoMed Inc. | Topline clinical data from the neflamapimod Phase 2a nfvPPA trial are expected in Q1 2027, separate from the 2026 biomarker presentations. | Estimated window | Primary source |
| Q1 2027 | $DMAC | DiaMedica Therapeutics Inc. | ReMEDy2 Phase 2/3 trial of DM199 in acute ischemic stroke: on October 22, 2026 the company announced that the 200th participant had been enrolled, reaching the prespecified threshold for the interim analysis. The independent DSMB will conduct the interim analysis after the first 200 participants complete 90-day follow-up, to assess sample size re-estimation or stopping for futility; if the trial continues, the final sample size will range between 300 and 728 participants. The company remains blinded and expects the interim analysis to be completed in the first quarter of 2027. | Estimated window | Finviz (news) |
| Q1 2027 | $DYN | DYNE THERAPEUTICS INC | Topline data: zeleciment basivarsen (DYNE-101) · Myotonic dystrophy type 1 (DM1) (Phase 1/2). Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Q1 2027 | $EDIT | Editas Medicine, Inc. | Initial Phase 1/2 Strive safety and tolerability data expected in Q1 2027; not the later Part 1 efficacy topline. Company guidance; exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $FLNA | Filana Therapeutics, Inc. | simufilam TSC epilepsy Phase 2a screening. Estimated window: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2026 / Q1 2027 | $GLUE | Monte Rosa Therapeutics, Inc. | GEMINI-1 Phase 2 initiation in gout expected Q4 2026 or Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $INBX | INHIBRX BIOSCIENCES INC | Interim data: ozekibart (INBRX-109) · colorectal cancer (CRC) (Phase 1). Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $IPHA | Innate Pharma S.A. | TELLOMAK-3 lacutamab first patient. Estimated window: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $LABT | Lakewood-Amedex Biotherapeutics Inc. | Nu-3 gel Phase 2a topline in mildly infected diabetic foot ulcers expected in Q1 2027. Separate from preclinical urinary and pulmonary infection findings announced October 7. Company guidance; no exact event day. | Estimated window | Primary source |
| Q1 2027 | $LGND | LIGAND PHARMACEUTICALS INC | Topline data: volixibat · cholestatic pruritus due to primary biliary cholangitis (PBC), VANTAGE (Phase 2b). Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $MIRA | MIRA Pharmaceuticals, Inc. | Ketamir-2 Phase 2a site initiation. Estimated window: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $MIRM | MIRUM PHARMACEUTICALS INC | Topline data: volixibat · Cholestatic pruritus due to primary biliary cholangitis (PBC), VANTAGE (Phase 2b). Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $NAMS | NEWAMSTERDAM PHARMA CO NV | Interim data: obicetrapib (Phase 3). Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $NKTR | NEKTAR THERAPEUTICS | Topline data: rezpegaldesleukin · Moderate-to-severe atopic dermatitis (AtD). Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $OCGN | Ocugen, Inc. | OCU400 Phase 3 liMeliGhT topline in retinitis pigmentosa. Estimated window: Q1 2027. Exact event day is not announced. The Bahamas provisional authorization is separate from FDA approval. | Estimated window | Primary source |
| Q1 2027 | $ORKA | ORUKA THERAPEUTICS INC | ORKA-002: Week 16 data from ORCA-SURGE, the Phase 2 trial in moderate-to-severe plaque psoriasis, expected in Q1 2027 after accelerated guidance. Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $PALI | Palisade Bio, Inc. | ASCENTRA-CD Phase 2 Crohn's first patient. Estimated window: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $PBLS | PARABILIS MEDICINES INC | Clinical data readout: zolucatetide · FAP. Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $PHVS | PHARVARIS NV | CREAATE Phase 3 Part 1 topline results for deucrictibant XR prevention of attacks of acquired angioedema due to C1-inhibitor deficiency. This is not the CHAPTER-3 hereditary-angioedema trial. Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Q1 2027 | $PPCB | Propanc Biopharma, Inc. | First-in-human Phase 1b PRP trial in advanced solid tumors planned for Q1 2027 in Australia, with up to 50 patients. Animal-model results do not establish human efficacy. Company guidance; no exact event day. | Estimated window | Primary source |
| Q1 2027 | $QNCX | IRulya Therapeutics Inc. (formerly Quince Therapeutics) | LAM-001 Phase 2 data in bronchiolitis obliterans syndrome after lung transplantation expected Q1 2027. Company guidance, not a confirmed day. IRulya is the current company name; QNCX changes to IRLA on October 12, 2026. | Estimated window | Primary source |
| Q1 2027 | $RAPP | RAPPORT THERAPEUTICS INC | FDA meeting: RAP-219 · acute bipolar mania. End-of-Phase 2 meeting with the FDA to discuss the Phase 2 data and registrational trial design. Company timing: Q1 2027. Exact event day is not announced. | Estimated window | SEC filing |
| Q1 2027 | $REPL | REPLIMUNE GROUP INC | Planned transition of the REVEAL registration-directed RP2 study from Phase 2 to Phase 3 in metastatic uveal melanoma. This does not specify a public interim-data release. Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $RNAC | Cartesian Therapeutics, Inc. | Descartes-08 AURORA Phase 3 generalized myasthenia gravis data expected Q1 2027 per company guidance. Distinct from the ClinicalTrials.gov primary-completion estimate. | Estimated window | Primary source |
| Q1 2027 | $SEPN | SEPTERNA INC | Initial data: SEP-479 · Hypoparathyroidism (Phase 1). Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $SION | Sionna Therapeutics, Inc. | AscenSION CF Phase 2a proof-of-concept trial of SION-451 + SION-2222 in adults with CF homozygous for F508del expected to begin Q1 2027. The previously disclosed PreciSION CF post-hoc analyses are not a new positive trial readout; its key activity endpoint was not achieved. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $SRPT | SAREPTA THERAPEUTICS INC | ELEVIDYS: 12-week data from the full ENDEAVOR Cohort 8, expected in Q1 2027. Full cohort enrollment is separately expected by year-end 2026. Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Year-end 2026 / Q1 2027 | $TGTX | TG THERAPEUTICS INC | Topline data: subcutaneous BRIUMVI (ublituximab) (Phase 3). Company timing: Year-end 2026 / Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $TLSA | Tiziana Life Sciences Ltd | Tiziana completed enrollment and initiated dosing in all patients of its Phase 2 randomized, placebo-controlled trial of intranasal foralumab in early/mild Alzheimer's disease, evaluating the drug as monotherapy and in combination with the anti-amyloid therapies lecanemab (Leqembi) or donanemab; on October 16, 2026, Tiziana announced that the last patient has begun dosing. Key endpoints include neuroinflammation measured by TSPO-PET imaging, cognitive function, and amyloid/tau fluid biomarkers. Topline data are expected in the first quarter of 2027 (company guidance; exact day not announced). | Estimated window | SEC filing |
| Q1 2027 | $TRAX | FIRST TRACKS BIOTHERAPEUTICS INC | Topline data: ANB033 · Celiac disease (Phase 1b). Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $TRDA | TRDA | ENTR-601-44: ELEVATE-44-201 Cohort 2 multiple-ascending-dose data (12 mg/kg), expected in Q1 2027. Distinct from Cohort 1 open-label follow-up. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $TTRX | Turn Therapeutics Inc. | GX-03 hidradenitis suppurativa Phase 2a first dosing planned in Q1 2027, subject to development and capital availability. Company guidance; no exact event day. | Estimated window | Primary source |
| Q1 2027 | $TTRX | Turn Therapeutics Inc. | GX-03 atopic dermatitis Phase 2 topline expected in Q1 2027. Company guidance; no exact event day announced. | Estimated window | Primary source |
| Q1 2027 | $TYRA | TYRA BIOSCIENCES INC | Initial data: oral dabogratinib · Achondroplasia (Phase 2). Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $VIR | VIR BIOTECHNOLOGY INC | Topline data: elebsiran and tobevibart · Chronic hepatitis delta (HDV) (Phase 3). Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Q1 2027 | $VRDN | VIRIDIAN THERAPEUTICS INC | NDA/BLA submission: elegrobart · thyroid eye disease (TED). Company timing: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2027 | $VSTM | Verastem, Inc. | Initial data from VS-7375 in combination with gemcitabine/nab-paclitaxel in first-line metastatic pancreatic cancer, expected in Q1 2027. Company guidance; no date announced. | Estimated window | SEC filing |
| Q1 2027 | $XENE | Xenon Pharmaceuticals Inc. | X-NOVA2 azetukalner Phase 3 MDD topline. Estimated window: Q1 2027. Exact event day is not announced. | Estimated window | Primary source |
| April 2027 | $ETON | ETON PHARMACEUTICALS INC | Expected U.S. launch of LIBERVANT (diazepam) buccal film by Eton in April 2027, subject to final FDA approval, after the competing orphan exclusivity expires on January 10, 2027. Company expectation; no launch day announced. | Estimated window | Primary source |
| Mid-2027 | $CCCC | C4 Therapeutics, Inc. | Cemsidomide plus elranatamab Phase 1b data from all evaluated cohorts expected mid-2027. Separate from Phase 1 dexamethasone data presented September 25, 2026. | Estimated window | Primary source |
| Early 2027 | $ABSI | ABSCI CORP | Topline data: ABS-201 · Pattern hair loss (PHL). Company timing: Early 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $AZN | AstraZeneca PLC | efzimfotase alfa PDUFA action for hypophosphatasia. Estimated window: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $BHC | BAUSCH HEALTH COMPANIES INC | Potential regulatory decision (company forecast): lumify (Phase 3). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $BIIB | Eisai Inc. | AMETHYST Phase 3 portion in cutaneous lupus erythematosus expected to read out H1 2027; remains blinded. Exact event day is not announced. | Estimated window | Primary source |
| Q2 2027 | $BMEA | Biomea Fusion, Inc. | COVALENT-212 Phase 2 icovamenib Week 26 primary-endpoint topline on background GLP-1 therapy. Estimated window: Q2 2027. Enrollment was still ongoing at the time of the source release; the date remains guidance. | Estimated window | Primary source |
| Early 2027 | $BMY | BRISTOL MYERS SQUIBB | Bristol Myers Squibb expects topline results from fully enrolled ALOFT-PPF in progressive pulmonary fibrosis in early 2027. This is a separate trial from ALOFT-IPF; no exact release date is announced. | Estimated window | Primary source |
| H1 2027 | $CLYM | Climb Bio, Inc. | CLYM116 NAVIGATE-2 Phase 2 initial data in IgA nephropathy. Estimated window: H1 2027. Exact event day is not announced. The study evaluates Q8W/Q12W dosing. | Estimated window | Primary source |
| Late 2026 / early 2027 | $COAG | HEMAB THERAPEUTICS HOLDINGS INC | Clinical data readout: sutacimig · Factor VII deficiency (Phase 2). Company timing: Late 2026 / early 2027. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 / early 2027 | $COAG | HEMAB THERAPEUTICS HOLDINGS INC | Interim data: HMB-002 · Von Willebrand disease (Phase 1/2). Company timing: Late 2026 / early 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Early Q2 2027 | $COYA | Coya Therapeutics, Inc. | ALSTARS Phase 2/3 ALS topline expected early Q2 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| H1 2027 | $DFTX | Definium Therapeutics | DT120 ODT — NDA submission planned in 1H 2027. | Estimated window | Primary source |
| H1 2027 | $DNLI | DENALI THERAPEUTICS INC | Clinical data readout: DNL151 (LRRK2 inhibitor) · Parkinson's disease (PD) (Phase 2a). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $DNLI | DENALI THERAPEUTICS INC | Initial data: DNL628 · Alzheimer's disease (AD) (Phase 1b). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Early 2027 | $DRTS | ALPHA TAU MEDICAL LTD | Initial data: Alpha DaRT · pancreatic cancer (PDAC), IMPACT. Company timing: Early 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Late 2026 / early 2027 | $DRTS | ALPHA TAU MEDICAL LTD | Topline data: Alpha DaRT · cutaneous squamous cell carcinoma ReSTART. Company timing: Late 2026 / early 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| H1 2027 | $ERAS | ERASCA INC | Interim data: ERAS-0015. Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q2 2027 | $ETON | ETON PHARMACEUTICALS INC | Regulatory decision: KHINDIVI (hydrocortisone). Company timing: Q2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $GLUE | Monte Rosa Therapeutics, Inc. | GALAXY-1 Phase 2 initiation in hidradenitis suppurativa expected H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $GLUE | Monte Rosa Therapeutics, Inc. | GFORCE-2 Phase 2b initiation in coronary artery disease expected H1 2027; design subject to regulatory feedback. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $GPCR | STRUCTURE THERAPEUTICS INC | Topline data: ACCG-2671. Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source Supporting source |
| H1 2027 | $HCWB | HCW Biologics Inc. | HCW11-018b solid-tumor IND submission remains planned for H1 2027 following FDA Type B guidance; neither IND submission nor clinical trial start has been confirmed. Company guidance, not an FDA decision date. Exact event day is not announced. | Estimated window | Primary source |
| Early 2027 | $HRMY | HARMONY BIOSCIENCES HOLDINGS INC | Topline data: BP-205 · Sleep-deprived healthy volunteers (Phase 1b). Company timing: Early 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $HRMY | HARMONY BIOSCIENCES HOLDINGS INC | Topline data: EPX-100 (clemizole hydrochloride) · Rare epilepsies: Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) (Phase 3). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Early 2027 | $HROW | HARROW INC | Topline data: TRIESENCE · ocular inflammation and pain following cataract surgery (Phase 3). Company timing: Early 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $HROW | HARROW INC | Planned MELT-300 NDA submission following completion of the nonclinical and pharmacokinetic studies needed for the application. Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 / early 2027 | $IDYA | IDEAYA BIOSCIENCES INC | Initial data: IDE034 (B7H3/PTK7 bispecific TOP1i ADC) (Phase 1). Company timing: Late 2026 / early 2027. Exact event day is not announced. | Estimated window | Primary source |
| Early 2027 | $IMCR | IMMUNOCORE HOLDINGS PLC | Interim data: IMC-M113V (Phase 1/2). Company timing: Early 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $IMTX | IMMATICS NV | Topline data: anzutresgene autoleucel (anzu-cel, IMA203) · Unresectable or metastatic melanoma (Phase 3). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $IOVA | IOVANCE BIOTHERAPEUTICS INC | Regulatory decision: Amtagvi (lifileucel) · melanoma. Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $IOVA | IOVANCE BIOTHERAPEUTICS INC | Initial data: Amtagvi (lifileucel) · cutaneous squamous cell carcinoma (CSCC) and Merkel cell carcinoma (MCC). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| By mid-2027 | $IRON | DISC MEDICINE INC | Regulatory decision: bitopertin in erythropoietic protoporphyria (EPP). After the positive APOLLO Phase 3 results, Disc plans to resubmit the NDA to the FDA by the end of 2026, with an FDA decision anticipated by mid-2027. Company timing; no date announced. | Estimated window | Primary source SEC filing SEC filing |
| H1 2027 | $IVA | Inventiva S.A. | Planned lanifibranor regulatory submission following NATiV3. Estimated window: H1 2027. Conditional on favorable NATiV3 results; filing is not approval. | Estimated window | Primary source |
| H1 2027 | $JANX | Janux Therapeutics, Inc. | JANX007 additional clinical data at a future medical congress. Estimated window: H1 2027. Congress and presentation day are not identified. | Estimated window | Primary source |
| H1 2027 | $KARD | KARDIGAN INC | Topline data: Tonlamarsen · Acute severe hypertension (Phase 2). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $KARD | KARDIGAN INC | Topline data: Danicamtiv · Genetic dilated cardiomyopathy (Phase 2b). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $KARD | KARDIGAN INC | Topline data: Ataciguat · Calcific aortic valve stenosis (Phase 2b). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q2 2027 | $KOD | Kodiak Sciences | KSI-101 BLA submission planned. Estimated window: Q2 2027. Company forward-looking plan dependent on development and regulatory execution; no exact filing day, acceptance, approval or PDUFA date announced. | Estimated window | Primary source |
| Q2 2027 | $KOD | Kodiak Sciences Inc. | KSI-101 Pivotal Analysis 2 (PEAK plus PINNACLE) topline expected Q2 2027 in macular edema secondary to inflammation. Distinct from PEAK Pivotal Analysis 1 in December 2026 and the separate BLA submission plan. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $KRRO | Korro Bio, Inc. | KRRO-111 (RNA-editing oligonucleotide for alpha-1 antitrypsin deficiency): regulatory submission expected in the first half of 2027, with the company planning to advance the program into the clinic in the same period. Current data are preclinical. Exact day not announced. | Estimated window | Primary source |
| H1 2027 | $KRRO | Korro Bio, Inc. | KRRO-121 dosing in patients with urea-cycle disorders is expected to start in H1 2027, subject to regulatory approval. This is separate from the healthy-volunteer component. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $KRYS | KRYSTAL BIOTECH INC | Interim data: KB707 · Solid tumors of the lung (Phase 1/2). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| H1 2027 | $LBRX | LB PHARMACEUTICALS INC | Topline data: LB-102 · schizophrenia (SCZ), NOVA-2 (Phase 3). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q2 2027 | $LGND | LIGAND PHARMACEUTICALS INC | Topline data: avim therapy. Company timing: Q2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $MANE | VERADERMICS INC | Topline data: VDPHL01 · Female pattern hair loss (Phase 2/3). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 / early 2027 | $MAZE | MAZE THERAPEUTICS INC | Interim data: MZE829 · APOL1-mediated kidney disease (AMKD), broad patient population (Phase 2). Company timing: Late 2026 / early 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q2 2027 | $MGTX | MEIRAGTX HOLDINGS PLC | Clinical data readout: AAV2-hAQP1 · Radiation-induced xerostomia (pivotal Phase 2). Company timing: Q2 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| H1 2027 | $MIRM | Mirum Pharmaceuticals, Inc. | Company expects to submit a brelovitug BLA for chronic hepatitis delta to FDA in H1 2027. This is a half-year window. | Estimated window | Primary source |
| H1 2027 | $MIRM | Mirum Pharmaceuticals, Inc. | Mirum plans a U.S. sNDA in H1 2027 based on positive EXPAND results in ultra-rare cholestatic liver diseases. Submission guidance; no FDA decision date is announced. | Estimated window | Primary source Company release |
| H1 2027 | $MIRM | MIRUM PHARMACEUTICALS INC | NDA/BLA submission: volixibat · cholestatic pruritus due to primary sclerosing cholangitis (PSC). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $MLTX | MoonLake Immunotherapeutics | IZAR-1 sonelokimab Phase 3 full Week 52 readout in psoriatic arthritis. Estimated: H1 2027. The trial remains blinded through Week 52. Exact event day is not announced. | Estimated window | Primary source |
| Early 2027 | $NKTR | Nektar Therapeutics | ZENITH AA, single registrational Phase 3 study of rezpegaldesleukin in severe-to-very-severe alopecia areata (850 patients; primary endpoint SALT Score ≤20 at Week 52), expected to initiate in early 2027. ESTIMATED window: early 2027. Exact day not announced. | Estimated window | SEC filing SEC filing Supporting source |
| H1 2027 | $NVO | Novo Nordisk | Denecimig US launch targeted H1 2027 conditional on approval; no FDA action date has been communicated after the manufacturing-related review extension. Exact event day is not announced. | Estimated window | Primary source |
| Q2 2027 | $OCGN | Ocugen, Inc. | OCU400 planned BLA submission for retinitis pigmentosa. Estimated window: Q2 2027. Exact event day is not announced; a planned filing is not FDA acceptance or approval. | Estimated window | Primary source |
| H1 2027 | $ONCY | Oncolytics Biotech Inc. | GOBLET Cohort 5: initial results of pelareorep-based therapy with chemotherapy, with and without atezolizumab, in first-line metastatic pancreatic ductal adenocarcinoma, expected in the first half of 2027; the company said timing could be extended as multiple patients continue treatment and follow-up. Company guidance; no date announced. | Estimated window | SEC filing |
| H1 2027 | $OPK | OPKO HEALTH INC | Initial data: MDX2004 (Phase 1). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Late 2026 / early 2027 | $OPK | OPKO HEALTH INC | Initial data: MDX2301 · prevention of COVID-19 (Phase 1). Company timing: Late 2026 / early 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $PBLS | PARABILIS MEDICINES INC | Clinical data readout: zolucatetide · ACP. Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $PCSA | Processa Pharmaceuticals, Inc. | VT7208 phase 2 initiation in relapsing multiple sclerosis planned for H1 2027. Company guidance in the October 5 SEC disclosure; the disclosure date is not necessarily the first announcement of this plan. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $PCVX | VAXCYTE INC | Clinical data readout: VAX-31 · invasive pneumococcal disease and pneumonia, OPUS-2 and OPUS-3 (Phase 3). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $PHAR | Pharming Group N.V. | Napazimone (KL1333) for mtDNA-driven mitochondrial disease: enrollment of the pivotal FALCON trial now expected to be completed in the first half of 2027, with approximately 145 of the planned 180 subjects enrolled by the end of 2026. Topline results are expected approximately one year after enrollment completion. Exact day not announced. | Estimated window | Primary source |
| H1 2027 | $PHVS | PHARVARIS NV | NDA/BLA submission: deucrictibant XR (PHVS719) · HAE CHAPTER-3 (Phase 3). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| H1 2027 | $PVLA | PALVELLA THERAPEUTICS INC | Regulatory decision: sirolimus (QTORIN rapamycin) · Microcystic lymphatic malformations (Phase 3). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $QURE | UNIQURE NV | Conference presentation: AMT-260 · Refractory mesial temporal lobe epilepsy (Phase I/IIa). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $RAPP | RAPPORT THERAPEUTICS INC | Phase 3 initiation: RAP-219 · primary generalized tonic-clonic seizures (PGTCS). Company timing: H1 2027. Exact event day is not announced. | Estimated window | SEC filing |
| H1 2027 | $RARE | ULTRAGENYX PHARMACEUTICAL INC | Topline data: avalotcagene ontaparvovec · ornithine transcarbamylase deficiency, Enh3ance (Phase 3). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $RCUS | ARCUS BIOSCIENCES INC | Clinical data readout: quemliclustat · Metastatic pancreatic ductal adenocarcinoma (PDAC) (Phase 3). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $RLAY | RELAY THERAPEUTICS INC | Zovegalisib plus atirmociclib and endocrine therapy: Phase 1/2 triplet clinical-data update in breast cancer, expected in H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $RNXT | RenovoRx | TIGeR-PaC Phase 3 in locally advanced pancreatic cancer: trial completion expected in H1 2027; enrollment completed in August 2026. Separate from the H2 2027 public topline. Company guidance; no exact event day announced. | Estimated window | Primary source |
| H1 2027 | $RXRX | RECURSION PHARMACEUTICALS INC | Interim data: REC-3565 (Phase 1). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $RXRX | RECURSION PHARMACEUTICALS INC | Interim data: REC-617 (Phase 1). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $RXRX | RECURSION PHARMACEUTICALS INC | Initial data: REC-4881 · familial adenomatous polyposis (FAP) (Phase 1b/2). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $SCTX | Scribe Therapeutics Inc. | STX-1150 Phase 1 initial single-ascending-dose clinical data. Estimated window: H1 2027. Planned data include safety, tolerability and LDL-C lowering. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $SRRK | Scholar Rock Holding Corporation | Scholar Rock expects a CHMP opinion on the resubmitted SMA application in H1 2027. Company guidance, not a confirmed regulator action date or European Commission approval. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $STOK | STOKE THERAPEUTICS INC | Initial safety and efficacy data from OSPREY cohorts 3 and 4 are expected in H1 2027. First two dose cohorts are complete; fourth-cohort dosing is subject to ongoing safety assessments. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $STOK | STOKE THERAPEUTICS INC | Company plans to submit data throughout H1 2027 in support of the zorevunersen NDA for Dravet syndrome. Submission completion is separately guided for H2 2027 after the Q3 EMPEROR readout. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $TARS | TARSUS PHARMACEUTICALS INC | TP-04 lotilaner ophthalmic-gel Phase 2 KORE topline results in ocular rosacea. TP-05/Calliope is a separate oral Lyme-disease prevention program. Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q2 2027 | $TCRX | TScan Therapeutics, Inc. | TSC-101 update on patients treated with the commercial-ready manufacturing process. Estimated: Q2 2027. Company continues patient follow-up despite enrollment pause; exact day not announced. | Estimated window | Primary source |
| H1 2027 | $TLX | Telix Pharmaceuticals Limited | OPTIMAL-PSMA, Phase 2 study of TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA) in metastatic androgen pathway modulator-resistant prostate cancer: enrollment of 120 patients completed; data readout expected in the first half of 2027. Exact day not announced. | Estimated window | Finviz (news) |
| H1 2027 | $TLX | TELIX PHARMACEUTICALS LTD | COMPOSE Phase 3 second interim analysis of ITM-11 in G2/G3 somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumors. Telix announced an agreement to acquire ITM; as of September 21, 2026, closing remained subject to conditions. Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| H1 2027 | $TRAX | FIRST TRACKS BIOTHERAPEUTICS INC | Phase 2 development of ANB033 in vitiligo and one additional indication is planned for H1 2027; the additional indication and exact start date are not disclosed. | Estimated window | Company release |
| H1 2027 | $TRDA | TRDA | ENTR-601-45: ELEVATE-45-201 Cohort 2 multiple-ascending-dose data at 10 mg/kg, expected in H1 2027. Distinct from ELEVATE-44-201 Cohort 2. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $TSHA | TAYSHA GENE THERAPIES INC | Topline data: TSHA-102 · Rett syndrome (RTT), REVEAL (pivotal). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $VOR | VOR BIOPHARMA INC | Topline data: telitacicept · Generalized myasthenia gravis (gMG) (Phase 3). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q2 2027 | $VSTM | Verastem, Inc. | Initial data from the Phase 2 TARGET-D 201 trial of VS-7375 in second-line pancreatic cancer, expected in Q2 2027 (enrollment expected to complete by year-end 2026). Company guidance; no date announced. | Estimated window | SEC filing |
| H1 2027 | $XNCR | XENCOR INC | Initial data: XmAb412 · Autoimmune and inflammatory disease. Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source |
| H1 2027 | $ZLAB | ZAI LAB LTD | Initial data: ZL-1503 (IL-13/IL-31R) · atopic dermatitis (AtD) (Phase 1/1b). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source ZLAB stock hub |
| H1 2027 | $ZLAB | ZAI LAB LTD | Topline data: ZL-6201 · sarcoma and selected tumors (Phase 1a/b). Company timing: H1 2027. Exact event day is not announced. | Estimated window | Primary source ZLAB stock hub |
| H1 2027 | $ZNTL | Zentalis Pharmaceuticals, Inc. | DENALI Part 2 integrated azenosertib topline in Cyclin E1-positive platinum-resistant ovarian cancer. Estimated window: H1 2027. Exact event day is not announced. Potential accelerated-approval support is conditional, not approval. | Estimated window | Primary source Supporting source |
| H1 2027 | $ZURA | Zura Bio Limited | TibuSURE: topline data from the Phase 2 study of tibulizumab in adults with systemic sclerosis, expected in the first half of 2027. Enrollment is complete with 91 participants randomized. Company guidance; no date announced. | Estimated window | SEC filing |
| Mid-2027 | $AEMD | Aethlon Medical, Inc. | NOR-101 Phase 1a interim PK and safety data, proposed merger. Estimated window: mid-2027. Exact event day is not announced. Aethlon/North merger is proposed and conditional; NRTX is only a proposed future ticker. | Estimated window | Primary source |
| Mid-2027 | $COAG | Hemab Therapeutics Holdings, Inc. | HMB-003 initial clinical data. Estimated window: mid-2027. Exact event day is not announced. | Estimated window | Primary source |
| Mid-2027 | $JAGX | Jaguar Health, Inc. | crofelemer MVID NDA filing. Estimated window: mid-2027. Exact event day is not announced. Subject to study completion and regulatory alignment. | Estimated window | Primary source |
| Mid-2027 | $KYTX | Kyverna Therapeutics, Inc. | KYSA-6 Phase 3 miv-cel enrollment completion. Estimated window: mid-2027. Exact event day is not announced. | Estimated window | Primary source |
| By July 2027; exact day unspecified | $RHHBY | F. Hoffmann-La Roche Ltd | Roche expects an FDA approval decision for vamikibart in uveitic macular edema by July 2027. BLA acceptance is confirmed; the company release did not disclose an exact FDA action date. | Estimated window | Primary source |
| Q3 2027 | $ACAD | ACADIA PHARMACEUTICALS INC | Topline data: ACP-211 · major depressive disorder (MDD) (Phase 2). Company timing: Q3 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q3 2027 | $BCRX | BIOCRYST PHARMACEUTICALS INC | Topline data: navenibart · hereditary angioedema (HAE) (pivotal). Company timing: Q3 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q3 2027 | $DYN | DYNE THERAPEUTICS INC | NDA/BLA submission: zeleciment basivarsen (DYNE-101) · myotonic dystrophy type 1 (DM1) (Phase 1/2). Company timing: Q3 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Q3 2027 | $RAPP | RAPPORT THERAPEUTICS INC | Phase 1 data: RAP-219 long-acting injectable formulation · pharmacokinetic data. Company timing: Q3 2027. Exact event day is not announced. | Estimated window | SEC filing |
| Q3 2027 | $STOK | STOKE THERAPEUTICS INC | Clinical data readout: zorevunersen · Dravet syndrome (DS) (Phase 3). Company timing: Q3 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q3 2027 | $TRAX | FIRST TRACKS BIOTHERAPEUTICS INC | Topline data: ANB033 · eosinophilic esophagitis (EoE) (Phase 1b). Company timing: Q3 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q3 2027 | $TTRX | Turn Therapeutics Inc. | GX-03 hidradenitis suppurativa Phase 2a topline expected in Q3 2027, conditional on execution and funding. Company guidance; no exact event day. | Estimated window | Primary source |
| Mid-2027 | $VTVT | vTv Therapeutics Inc. | CATT1 Phase 3 topline in type 1 diabetes expected mid-2027. Distinct from registry primary completion. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| 2027 | $ABCL | ABCELLERA BIOLOGICS INC | IND submission: ABCL688 · Autoimmunity. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $ABSI | ABSCI CORP | Interim data: ABS-201 · Endometriosis, HEADLINE (Phase 2). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| Mid-2027 (approximate) | $ABVX | ABIVAX SA | Topline data: obefazimod · Crohn's disease (CD) (Phase 2b). Company timing: Mid-2027 (approximate). Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $ALKS | ALKERMES PLC | Clinical data readout: ALKS 7290 · attention-deficit hyperactivity disorder (ADHD) (Phase 2). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| 2027 | $ALMR | ALAMAR BIOSCIENCES INC | Device marketing authorization submission: ARGO HT/DX instrument. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $ALT | Altimmune, Inc. | RESTORE Phase 2 pemvidutide topline in alcohol-associated liver disease. Estimated window: H2 2027. Enrollment completed in July 2026. The topline concerns the updated 48-week endpoint, not enrollment. Exact release day is not announced. | Estimated window | Primary source |
| 2027 | $AMLX | AMYLYX PHARMACEUTICALS INC | IND submission: AMX0318 · PBH and other rare diseases. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $ARWR | Arrowhead Pharmaceuticals | Data from the early Alzheimer's disease cohorts of the ARO-MAPT Phase 1/2a study, expected in 2027 per Arrowhead's October 14, 2026 release. The October 14 interim healthy-volunteer data showed mean CSF tau reductions of 40%, 69% and 73% at Day 105 (maximum 85%). Company expectation; no date announced. | Estimated window | Primary source |
| H2 2027 | $AVLN | AVALYN PHARMA INC | Topline data: ap01 (inhaled pirfenidone) · Progressive pulmonary fibrosis (Phase 2b). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| Late 2027 | $AVLN | AVALYN PHARMA INC | Topline data: ap02 (inhaled nintedanib) · idiopathic pulmonary fibrosis (IPF) (Phase 2). Company timing: Late 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $AXSM | AXSOME THERAPEUTICS INC | Topline data: solriamfetol · shift work disorder, SUSTAIN (Phase 3). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| Mid-2027 (approximate) | $BCAX | BICARA THERAPEUTICS INC | Interim data: ficerafusp alfa · 1L R/M HPV-negative HNSCC, FORTIFI-HN01 (Phase 3). Company timing: Mid-2027 (approximate). Exact event day is not announced. | Estimated window | Primary source |
| Late 2027 | $BCRX | BIOCRYST PHARMACEUTICALS INC | NDA/BLA submission: navenibart. Company timing: Late 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $BIOA | BioAge Labs, Inc. | QUELL-DME BGE-102 Phase 2 topline in diabetic macular edema. Estimated window: H2 2027. Exact event day is not announced. Primary endpoint is BCVA change at week 12. | Estimated window | Primary source |
| H2 2027 | $BRVE | BRAVEHEART BIO INC | Interim data: BHB-1893 · obstructive HCM ("oHCM") (Phase 3). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $CLDX | Celldex Therapeutics, Inc. | barzolvolimab CSU BLA submission. Estimated window: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $CNMD | CONMED CORP | Clinical data readout: BioBrace · rotator cuff. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $DFTX | DEFINIUM THERAPEUTICS INC | Topline data: DT120 ODT · Major depressive disorder (MDD) (Phase 3). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| Mid-2027 (approximate) | $DMRA | DAMORA THERAPEUTICS INC | Initial data: DMR-001 · essential thrombocythemia (ET) and myelofibrosis (MF). Company timing: Mid-2027 (approximate). Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $DMRA | DAMORA THERAPEUTICS INC | IND submission: DMR-003. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $DNLI | DENALI THERAPEUTICS INC | Initial data: DNL952 · Pompe disease (Phase 1). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $DNLI | DENALI THERAPEUTICS INC | Clinical data readout: DNL921 · Alzheimer's disease (AD) (Phase 1/1b). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $DNLI | DENALI THERAPEUTICS INC | Clinical data readout: DNL593 · granulin (GRN)-related frontotemporal dementia (FTD-GRN) (Phase 1/2). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $DNLI | DENALI THERAPEUTICS INC | NDA/BLA submission: zafinofusp alfa (DNL126; ETV:SGSH) · Sanfilippo syndrome type A (Phase 3). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| By year-end 2027 | $DNTH | DIANTHUS THERAPEUTICS INC | DNTH312 development target is Phase 1 readiness by year-end 2027. The quoted statement does not establish an IND filing date or first-patient dosing date. Company timing: By year-end 2027. Exact event day is not announced. | Estimated window | Primary source |
| Later in 2027; quarter unspecified | $EDIT | Editas Medicine, Inc. | Editas plans Part 1 dose-finding enrollment completion and topline safety/efficacy results later in 2027. The release does not specify a quarter. Company guidance; no exact event day announced. | Estimated window | Primary source |
| H2 2027 | $ETON | ETON PHARMACEUTICALS INC | NDA/BLA submission: ASN-001 · Moderate infantile hemangiomas. Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $GLUE | Monte Rosa Therapeutics, Inc. | Initial GEMINI-1 Phase 2 gout data expected H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2027 | $HCM | HUTCHMED (CHINA) LTD | Topline data: IMG-007 · moderate-to-severe atopic dermatitis (AtD) (Phase 2b). Company timing: Q4 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| 2027 | $HRMY | HARMONY BIOSCIENCES HOLDINGS INC | Topline data: Pitolisant HD · Narcolepsy; idiopathic hypersomnia (Phase 3). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| Mid-2027 (approximate) | $HRMY | HARMONY BIOSCIENCES HOLDINGS INC | Pitolisant (WAKIX): topline data from the Phase 3 TEMPO study in Prader-Willi syndrome are expected around mid-2027. This is distinct from pitolisant GR in narcolepsy. Company timing: Mid-2027 (approximate). Exact event day is not announced. | Estimated window | Primary source |
| Mid-2027 (approximate) | $IDYA | IDEAYA BIOSCIENCES INC | Interim data: darovasertib combination · Metastatic uveal melanoma. Company timing: Mid-2027 (approximate). Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $IMCR | IMMUNOCORE HOLDINGS PLC | Initial data: IMC-R117C · advanced solid tumors, including colorectal cancer (CRC) (Phase 1/2). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $IMTX | IMMATICS NV | IMA401 (MAGEA4/8) plus IMA402 (PRAME): first clinical data from the combination cohort in squamous non-small-cell lung cancer expected in 2027. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| 2027 | $IMTX | IMMATICS NV | Anzu-cel BLA submission planned in 2027 after final SUPRAME progression-free-survival topline data expected in the first half of 2027. The newer August guidance no longer specifies a first-half filing deadline. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $IMVT | IMMUNOVANT INC | Topline data: imeroprubart (IMVT-1402) · Graves' disease (potentially registrational). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| 2027 | $IMVT | IMMUNOVANT INC | Topline data: imeroprubart (IMVT-1402) · myasthenia gravis (gMG) (potentially registrational). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Mid-2027 (approximate) | $INBX | INHIBRX BIOSCIENCES INC | Initial data: INBRX-106 · non-small cell lung cancer (NSCLC) (Phase 1/2). Company timing: Mid-2027 (approximate). Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $IONS | IONIS PHARMACEUTICALS INC | Clinical data readout: obudanersen · Angelman syndrome, REVEAL (Phase 3). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source IONS stock hub |
| 2027 | $IONS | IONIS PHARMACEUTICALS INC | NDA/BLA submission: ZANVASTRO (zilganersen). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source IONS stock hub |
| 2027 | $IOVA | IOVANCE BIOTHERAPEUTICS INC | Marketing authorization resubmission: Amtagvi (lifileucel) · Advanced melanoma. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $IRON | DISC MEDICINE INC | Initial data: selcodebart (DISC-0974) · inflammatory bowel disease (IBD) (Phase 2). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| By Q4 2027 | $KAPA | Kairos Pharma | Company expects trial completion in or before Q4 2027, following protocol modification and randomized enzalutamide with or without ENV105. This is completion guidance, not a confirmed results date. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $KLRA | KAILERA THERAPEUTICS INC | Clinical data readout: HRS-7535 (KAI-7535) · Obesity (Phase 2). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $KLRA | KAILERA THERAPEUTICS INC | Clinical data readout: HRS-4729 (KAI-4729) (Phase 1). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| Mid-2027 (approximate) | $KLRA | KAILERA THERAPEUTICS INC | Ribupatide injection: Phase 2b high-dose obesity data in 264 participants with BMI at least 35 and no type 2 diabetes. The 48-week trial evaluates 10, 13, 16 and 20 mg weekly doses; data anticipated around mid-2027. Company timing: Mid-2027 (approximate). Exact event day is not announced. | Estimated window | Primary source Supporting source |
| H2 2027 | $KRRO | Korro Bio, Inc. | Interim clinical readout from the KRRO-121 ANCHOR program expected in H2 2027 according to company guidance. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $KRYS | KRYSTAL BIOTECH INC | Interim data: KB408 · alpha-1 antitrypsin deficiency (AATD) lung disease (Phase 1). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| 2027 | $KYMR | KYMERA THERAPEUTICS INC | IND submission: KT-200 · breast cancer and other solid tumors. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| Late 2027 | $KYMR | KYMERA THERAPEUTICS INC | Clinical data readout: KT-621 · Asthma (Phase 2b). Company timing: Late 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $LBRX | LB PHARMACEUTICALS INC | FDA meeting: LB-102 · schizophrenia (SCZ) (Phase 3). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $LGND | LIGAND PHARMACEUTICALS INC | Topline data: lasofoxifene · metastatic breast cancer, ELAINE-3 (Phase 3). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $LGND | LIGAND PHARMACEUTICALS INC | Topline data: Qtorin 3.9% rapamycin anhydrous gel (Qtorin rapamycin) · Angiokeratomas (Phase 2). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $LPCN | Lipocine Inc. | Topline data: LPCN 1154 (oral brexanolone) · severe postpartum depression, BLOOM Phase 3 (randomized, double-blind, placebo-controlled US study, N=120; primary endpoint HAM-D17 change from baseline at Hour 60 versus placebo). Company timing: 2H 2027. Exact event day is not announced. | Estimated window | SEC filing |
| Q4 2027 | $LSTA | Lisata Therapeutics, Inc. | MAR002 acromegaly Phase 2 topline. Estimated window: Q4 2027. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2027 | $LSTA | Lisata Therapeutics, Inc. | MAR001 severe hypertriglyceridemia Phase 2b topline. Estimated window: Q4 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $LTGO | Latigo Biotherapeutics, Inc. | LTG-321 Phase 2 topline in osteoarthritis knee pain. Estimated window: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $LTGO | Latigo Biotherapeutics, Inc. | Onzotrigine Phase 3 bunionectomy and open-label safety topline. Estimated window: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $LXEO | Lexeo Therapeutics, Inc. | SUNRISE-FA 2 LX2006 topline. Estimated window: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $MAIA | MAIA Biotechnology, Inc. | THIO-104 Phase 3 interim analysis in third-line NSCLC targeted in 2027. The issuer does not specify a quarter or public release day. Company guidance; no exact event day. | Estimated window | Primary source Trial registry |
| 2027 | $MAZE | MAZE THERAPEUTICS INC | Topline data: MZE782 · phenylketonuria (PKU) (Phase 2). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $MBX | MBX BIOSCIENCES INC | MBX 4291: topline results from the Phase 1 obesity study are anticipated in 2027. The program studies single and multiple ascending doses of a GLP-1/GIP co-agonist prodrug; this overall readout is distinct from the first 12-week cohort update in Q4 2026. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| Mid-2027 (approximate) | $MESO | MESOBLAST LTD | Topline data: rexlemestrocel-l · chronic low back pain (CLBP) (Phase 3). Company timing: Mid-2027 (approximate). Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $MESO | MESOBLAST LTD | NDA/BLA submission: rexlemestrocel-l · Chronic low back pain (Phase 3). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| Mid-2027 (approximate) | $MGTX | MEIRAGTX HOLDINGS PLC | NDA/BLA submission: AAV2-hAQP1 · Radiation-induced xerostomia (pivotal). Company timing: Mid-2027 (approximate). Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $MIRM | MIRUM PHARMACEUTICALS INC | Topline data: MRM-3379 · Fragile X syndrome, BLOOM (Phase 2). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $MIRM | MIRUM PHARMACEUTICALS INC | Topline data: brelovitug · chronic hepatitis delta virus (HDV) infection, AZURE-2 and AZURE-3 (Phase 3). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $MIRM | MIRUM PHARMACEUTICALS INC | Potential US regulatory approval of brelovitug after the planned H1 2027 BLA submission, subject to FDA review. The September 28 update targets a potential US commercial launch in Q4 2027 if approved. Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| Late 2027 | $MNKD | MANNKIND CORP | Clinical data readout: insulin human (Afrezza) · newly diagnosed type 1 diabetes (T1D). Company timing: Late 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $NGEN | NervGen | RESTORE Phase 3 enrollment completion is expected in H2 2027. The study plans approximately 150 participants; this is a recruitment milestone, not a results date. | Estimated window | Company release Trial registry |
| 2027 | $NKTR | NEKTAR THERAPEUTICS | Initial data: rezpegaldesleukin · type 1 diabetes mellitus (T1D) (Phase 2). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $NUVB | NUVATION BIO INC | Clinical data readout: safusidenib · grade 3 IDH1-mutant oligodendroglioma. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $OGN | ORGANON & CO | Regulatory decision: Nexplanon. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $PCSA | Processa Pharmaceuticals, Inc. | VT7208 proof-of-concept data in peanut allergy planned for H2 2027. Company guidance in the October 5 SEC disclosure; the disclosure date is not necessarily the first announcement of this plan. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $PCVX | VAXCYTE INC | Topline data: VAX-A1 · Disease caused by Group A Streptococcus (Phase 1). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $PODD | INSULET CORP | 510(k) submission: fully closed-loop automated insulin delivery (AID) system · Type 2 diabetes (T2D), EVOLVE (pivotal). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $PRAX | PRAXIS PRECISION MEDICINES INC | Topline data: elsunersen · SCN2A DEE (EMBRAVE3). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $PRAX | PRAXIS PRECISION MEDICINES INC | NDA/BLA submission: vormatrigine · focal onset seizures (FOS), POWER1 and POWER2 (Phase 3). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $PRAX | PRAXIS PRECISION MEDICINES INC | NDA/BLA submission: relutrigine · SCN2A and SCN8A DEEs, EMERALD. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $PRAX | PRAXIS PRECISION MEDICINES INC | Topline data: vormatrigine · FOS (Phase 3). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $PRME | Prime Medicine | Initial PM577a Phase 1/2 clinical data in H1069Q-mutated Wilson disease expected during 2027. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| H2 2027 | $PVLA | PALVELLA THERAPEUTICS INC | Topline data: sirolimus (QTORIN rapamycin) · Clinically significant angiokeratomas, LOTU (Phase 2). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $RAPP | RAPPORT THERAPEUTICS INC | Phase 1 data: RAP-641 · preliminary results. Company timing: H2 2027. Exact event day is not announced. | Estimated window | SEC filing |
| H2 2027 | $RAPP | RAPPORT THERAPEUTICS INC | Phase 3 initiation: RAP-219 · acute bipolar mania. Start of two Phase 3 pivotal trials. Company timing: H2 2027. Exact event day is not announced. | Estimated window | SEC filing |
| 2027 | $RAPP | RAPPORT THERAPEUTICS INC | Initial data: RAP-219. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| Mid-2027; exact range unspecified | $RCKT | Rocket Pharmaceuticals, Inc. | Rocket guides pivotal Danon Phase 2 dosing completion to mid-2027. No exact day or quarter is given. Company guidance. | Estimated window | Primary source |
| Mid-2027 (approximate) | $RCUS | ARCUS BIOSCIENCES INC | AB102 proof-of-concept study milestone in chronic spontaneous urticaria. The quoted source forecasts the study, not a dated release of initial results. Company timing: Mid-2027 (approximate). Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $REGN | Regeneron Pharmaceuticals | The three preclinical antibodies added to the Sanofi alliance, targeting IL-4xIL-13, IL-4 and IL-4Ralpha, are expected to enter clinical studies in 2027. Portfolio-level company guidance; specific study dates and indications not announced. Distinct from REGN20423, already in Phase 1. Exact event day is not announced. | Estimated window | Primary source Supporting source |
| H2 2027 | $REPL | REPLIMUNE GROUP INC | RP1 (vusolimogene oderparepvec) plus nivolumab: interim overall-survival analysis from the randomized Phase 3 IGNYTE-3 trial in advanced melanoma is planned for H2 2027. This is distinct from the primary overall-survival readout expected in 2030. Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $RNXT | RenovoRx | TIGeR-PaC Phase 3 public topline in locally advanced pancreatic cancer expected in H2 2027. Company guidance; no exact event day. | Estimated window | Primary source |
| H2 2027 | $RXRX | RECURSION PHARMACEUTICALS INC | Interim data: REC-4539 (Phase 1). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $SABS | SAB Biotherapeutics, Inc. | SAFEGUARD SAB-142 Phase 2b topline. Estimated window: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $SCYX | SCYNEXIS, Inc. | SCY-770 Phase 2 early efficacy data. Estimated window: H2 2027. Exact event day is not announced. | Estimated window | Primary source Supporting source |
| 2027 | $SCYX | SCYNEXIS, Inc. | SCY-247: the company expects to initiate Phase 2 development in oral and IV formulations in 2027, subject to regulatory agreement, after completing the Phase 1 study of intravenous SCY-247 (October 22, 2026). Exact day not announced. | Estimated window | Primary source |
| H2 2027 | $SGMT | Sagimet Biosciences Inc. | Topline results from AURORA, the pivotal U.S. Phase 3 trial of denifanstat in moderate to severe acne, expected in the second half of 2027 according to the company. Exact day not announced. | Estimated window | Primary source |
| 2027 | $SNDX | SYNDAX PHARMACEUTICALS INC | IND submission: SNDX-62122 · Myelofibrosis. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $SNDX | SYNDAX PHARMACEUTICALS INC | Initial data: Revuforj (revumenib) · myelofibrosis (MF) (Phase 1/2). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $SRZN | Surrozen | Initial DUET Phase 1b/2a data expected H2 2027 per company guidance. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $STOK | Stoke Therapeutics, Inc. | Zorevunersen NDA completion planned H2 2027 after Q3 2027 EMPEROR topline, subject to supporting data. Exact event day is not announced. | Estimated window | Primary source |
| Mid-2027 (approximate) | $SUPN | SUPERNUS PHARMACEUTICALS INC | Potential FDA authorization of a second supplier for ONAPGO. This concerns manufacturing supply for an already approved treatment, not initial marketing approval. Company timing: Mid-2027 (approximate). Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $SYRE | SPYRE THERAPEUTICS INC | Topline data: SPY001, SPY002, SPY003, SPY120, SPY130, SPY230 · Ulcerative colitis (UC) (Phase 2). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $TARS | TARSUS PHARMACEUTICALS INC | Regulatory decision: XDEMVY (lotilaner ophthalmic solution) · Demodex blepharitis. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $TRAX | FIRST TRACKS BIOTHERAPEUTICS INC | First Tracks plans to initiate a late-stage ANB033 trial in celiac disease in 2027. Exact timing and the trial phase are not specified in the October 12 release. | Estimated window | Company release |
| H2 2027 | $TRVI | TREVI THERAPEUTICS INC | Topline data: Haduvio (oral nalbuphine ER) · idiopathic pulmonary fibrosis (IPF)-related chronic cough, OCEAN-2 (Phase 3). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $TRVI | TREVI THERAPEUTICS INC | Topline data: Haduvio (oral nalbuphine ER) · Refractory chronic cough; IPF-related chronic cough; non-IPF ILD-related chronic cough (Phase 2b). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| Mid-2027 guidance; exact day unspecified | $TTRX | Turn Therapeutics Inc. | GX-03 atopic dermatitis Phase 3 initiation planned in 2027, described as mid-2027 in the pipeline slide. Conditional on preceding development and funding. Company guidance; no exact event day announced. | Estimated window | Primary source |
| 2027 | $TVTX | TRAVERE THERAPEUTICS INC | Conference presentation: FILSPARI (sparsentan) · recurrent IgAN or FSGS. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $TVTX | TRAVERE THERAPEUTICS INC | Topline data: pegtibatinase · classical Homocystinuria (HCU) (Phase 3). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $TYRA | TYRA BIOSCIENCES INC | Initial data: oral dabogratinib · FGFR3-altered low-grade upper tract urothelial carcinoma (LG-UTUC) (Phase 2a/b). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| Mid-2027 (approximate) | $VCRE | VICORE PHARMA HOLDING AB | Topline data: buloxibutid · IPF. Company timing: Mid-2027 (approximate). Exact event day is not announced. | Estimated window | Primary source Supporting source |
| 2027 | $VERA | VERA THERAPEUTICS INC | Regulatory decision: atacicept · IgA nephropathy (IgAN) (Phase 3). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $VIR | Vir Biotechnology, Inc. | Vir and Astellas anticipate starting pivotal Phase 3 trials of VIR-5500 in prostate cancer in 2027, without a specified quarter. Company guidance; no exact event day. | Estimated window | Primary source |
| 2027 | $VKTX | Viking Therapeutics | Results of Part 2 maintenance dosing in obesity expected during 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $VSTM | Verastem, Inc. | Initial data from the Phase 2 TARGET-D 202 (second-line NSCLC) and TARGET-D 203 (second-line colorectal cancer) trials of VS-7375, expected in the second half of 2027. Company guidance; no date announced. | Estimated window | SEC filing |
| 2027 | $XENE | XENON PHARMACEUTICALS INC | Initial data: NBI-921355 · Certain types of epilepsy (Phase 1). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| H2 2027 | $XNCR | XENCOR INC | Topline data: XmAb942 (Xtend TL1A) · ulcerative colitis (UC) (Phase 2b). Company timing: H2 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $XNCR | XENCOR INC | Phase 1 combination dose escalation of XmAb541 and XmAb808 is expected to reach its target dose range in 2027. No dated interim-data disclosure is specified. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $ZBIO | ZENAS BIOPHARMA INC | ZB022: Phase 1 initiation for the oral, brain-penetrant TYK2-JH2 inhibitor is expected in 2027, subject to IND-enabling study results and regulatory clearance. This replaces the earlier 2026 plan. Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| 2027 | $ZLAB | ZAI LAB LTD | Topline data: elegrobart · thyroid eye disease (TED) (Phase 3). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source ZLAB stock hub |
| 2027 | $ZLAB | ZAI LAB LTD | IND submission: ZL-1222 (PD-1 / IL-12) (Phase 1). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source ZLAB stock hub |
| 2027 | $ZYME | ZYMEWORKS INC | IND submission: ZW1528 · chronic obstructive pulmonary disease (COPD) (Phase 1). Company timing: 2027. Exact event day is not announced. | Estimated window | Primary source |
| Approximately November 2027-January 2028 (18-20 months from May 11, 2026) | $HROW | HARROW INC | FDA filing planned for the TRIESENCE prefilled-syringe format within 18-20 months of the May 11, 2026 update. This corresponds approximately to November 2027-January 2028 and is separate from the cataract-surgery/pain clinical study. Company timing: Approximately November 2027-January 2028 (18-20 months from May 11, 2026). Exact event day is not announced. | Estimated window | Primary source |
| Q1 2028 | $LBRX | LB PHARMACEUTICALS INC | Topline data: LB-102 · Bipolar depression, ILLUMINATE-1 (Phase 2). Company timing: Q1 2028. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2028 | $OCUL | OCULAR THERAPEUTIX INC | Topline data: AXPAXLI · wet AMD (nAMD), SOL-R (Phase 3). Company timing: Q1 2028. Exact event day is not announced. | Estimated window | Primary source |
| Early 2028 | $PALI | Palisade Bio, Inc. | ASCENTRA-CD Crohn's Phase 2 primary efficacy readout. Estimated window: early 2028. Exact event day is not announced. | Estimated window | Primary source |
| Q1 2028 | $QNCX | IRulya Therapeutics Inc. (formerly Quince Therapeutics) | LAM-001 Phase 2b data in pulmonary hypertension associated with interstitial lung disease expected Q1 2028. Company guidance, not a confirmed day. IRulya is the current company name; QNCX changes to IRLA on October 12, 2026. | Estimated window | Primary source |
| H1 2028 | $HROW | HARROW INC | G-MELT: potential FDA approval in H1 2028 under the company development plan, following the intended H1 2027 NDA submission. This is a conditional forecast, not an assigned PDUFA deadline; potential launch is a separate H2 2028 milestone. Company timing: H1 2028. Exact event day is not announced. | Estimated window | Primary source |
| H1 2028 | $NGEN | NervGen | NervGen expects RESTORE Phase 3 topline results in H1 2028 in chronic cervical motor-incomplete spinal cord injury. | Estimated window | Company release Trial registry |
| H1 2028 | $PCSA | Processa Pharmaceuticals, Inc. | VT7208 proof-of-concept data in chronic spontaneous urticaria planned for H1 2028. Company guidance in the October 5 SEC disclosure; the disclosure date is not necessarily the first announcement of this plan. Exact event day is not announced. | Estimated window | Primary source |
| H1 2028 | $PCVX | VAXCYTE INC | VAX-31 adult BLA submission planned in H1 2028, subject to supporting development data; company guidance, not an FDA-confirmed date. Exact event day is not announced. | Estimated window | Primary source |
| Early 2028 | $SNDX | SYNDAX PHARMACEUTICALS INC | Topline data: axatilimab · chronic graft-versus-host disease (GVHD) (Phase 3). Company timing: Early 2028. Exact event day is not announced. | Estimated window | Primary source |
| Early 2028 | $STOK | STOKE THERAPEUTICS INC | Potential US approval and launch targeted in early 2028, conditional on supporting data, NDA submission and FDA review. Not a confirmed FDA deadline. Exact event day is not announced. | Estimated window | Primary source |
| Late 2027 / early 2028 | $SYRE | SPYRE THERAPEUTICS INC | Clinical data readout: SPY072 + IL-17A/F · HS. Company timing: Late 2027 / early 2028. Exact event day is not announced. | Estimated window | Primary source |
| H1 2028 | $TRVI | TREVI THERAPEUTICS INC | Topline data: Haduvio (oral nalbuphine ER) · idiopathic pulmonary fibrosis (IPF)-related chronic cough, OCEAN-1 (Phase 3). Company timing: H1 2028. Exact event day is not announced. | Estimated window | Primary source |
| H1 2028 | $TTRX | Turn Therapeutics Inc. | GX-03 onychomycosis Phase 3 interim analysis guided to H1 2028, conditional on trial execution and funding. The presentation conflicts on initiation timing (Q1 versus Q2 2027); no start date has been confirmed. Company guidance; no exact event day announced. | Estimated window | Primary source |
| Late 2027 / early 2028 | $ZYME | ZYMEWORKS INC | Topline data: EmpowHER-303 HER-303. Company timing: Late 2027 / early 2028. Exact event day is not announced. | Estimated window | Primary source |
| 2028 | $ANAB | ANAPTYSBIO INC | Topline data: Jemperli (dostarlimab) · colorectal cancer (CRC) and dMMR pan tumors (Phase 3). Company timing: 2028. Exact event day is not announced. | Estimated window | Primary source ANAB stock hub |
| Late 2028 | $CELC | CELCUITY INC | Topline data: REVTORPYK (gedatolisib) · endocrine-resistant HR+/HER2- ABC (Phase 3). Company timing: Late 2028. Exact event day is not announced. | Estimated window | Primary source |
| H2 2028 | $DNTH | DIANTHUS THERAPEUTICS INC | Topline data: claseprubart · Generalized myasthenia gravis (gMG), EMERGE (Phase 3). Company timing: H2 2028. Exact event day is not announced. | Estimated window | Primary source |
| H2 2028 | $GPCR | STRUCTURE THERAPEUTICS INC | Topline data: aleniglipron · chronic weight management, ACCOMPLISH-1 and ACCOMPLISH-2 (Phase 3). Company timing: H2 2028. Exact event day is not announced. | Estimated window | Primary source |
| 2028 | $HCM | HUTCHMED (CHINA) LTD | Initial data: IMG-007 · Alopecia areata (Phase II). Company timing: 2028. Exact event day is not announced. | Estimated window | Primary source |
| 2028 | $HELP | Cybin Inc. doing business as Helus Pharma | HLP003 (adjunctive treatment of major depressive disorder): Helus Pharma expects to file a New Drug Application with the FDA in 2028. Exact day not announced; a planned filing is not FDA acceptance or approval. | Estimated window | Primary source |
| 2028 | $HRMY | HARMONY BIOSCIENCES HOLDINGS INC | Potential regulatory decision (company forecast): WAKIX (pitolisant) (Phase 3). Company timing: 2028. Exact event day is not announced. | Estimated window | Primary source |
| 2028 | $HRMY | HARMONY BIOSCIENCES HOLDINGS INC | Potential regulatory decision (company forecast): Pitolisant HD · Narcolepsy. Company timing: 2028. Exact event day is not announced. | Estimated window | Primary source |
| 2028 | $HRMY | HARMONY BIOSCIENCES HOLDINGS INC | Potential regulatory decision (company forecast): EPX-100 (clemizole hydrochloride) · Dravet syndrome (DS) and Lennox-Gastaut syndrome; rare epilepsies (Phase 3). Company timing: 2028. Exact event day is not announced. | Estimated window | Primary source |
| 2028 | $IMVT | IMMUNOVANT INC | Topline data: imeroprubart (IMVT-1402) · Sjögren's disease (potentially registrational). Company timing: 2028. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| 2028 | $IMVT | IMMUNOVANT INC | Topline data: imeroprubart (IMVT-1402) · chronic inflammatory demyelinating polyneuropathy (CIDP) (potentially registrational). Company timing: 2028. Exact event day is not announced. | Estimated window | Primary source Trial registry |
| 2028 | $KLRA | KAILERA THERAPEUTICS INC | Clinical data readout: ribupatide injection (KAI-9531) · Obesity (Phase 3). Company timing: 2028. Exact event day is not announced. | Estimated window | Primary source |
| 2028 | $LGND | LIGAND PHARMACEUTICALS INC | Clinical data readout: Qarziba · Neuroblastoma, BEACON-2. Company timing: 2028. Exact event day is not announced. | Estimated window | Primary source |
| Mid-2028 (approximate) | $NKTR | NEKTAR THERAPEUTICS | Clinical data readout: rezpegaldesleukin (Phase 3). Company timing: Mid-2028 (approximate). Exact event day is not announced. | Estimated window | Primary source |
| H2 2028 | $PCSA | Processa Pharmaceuticals, Inc. | VT7208 proof-of-concept data in relapsing multiple sclerosis planned for H2 2028, per company guidance disclosed in an October 5 SEC filing. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2028 | $QNCX | IRulya Therapeutics Inc. (formerly Quince Therapeutics) | LAM-001 Phase 2 data in sarcoidosis-associated pulmonary hypertension expected Q4 2028. Company guidance, not a confirmed day. IRulya is the current company name; QNCX changes to IRLA on October 12, 2026. | Estimated window | Primary source |
| Mid-2028; exact range unspecified | $RCKT | Rocket Pharmaceuticals, Inc. | Rocket guides pivotal Danon Phase 2 topline to mid-2028. No exact day or quarter has been given. Exact event day is not announced. | Estimated window | Primary source |
| 2028 | $TARS | TARSUS PHARMACEUTICALS INC | Topline data: aqueous chlorine dioxide solution (IRX-101) COMFORT (Phase 3). Company timing: 2028. Exact event day is not announced. | Estimated window | Primary source |
| Q4 2028 | $TTRX | Turn Therapeutics Inc. | GX-03 onychomycosis Phase 3 topline guided to Q4 2028, conditional on execution and funding. Initiation timing remains inconsistent across issuer slides. Company guidance; no exact event day. | Estimated window | Primary source |
| Late 2028 | $XERS | XERIS BIOPHARMA HOLDINGS INC | XP-8121: topline results from the Cornerstone Phase 3 program in hypothyroidism are forecast for late 2028. This is a company development projection. Company timing: Late 2028. Exact event day is not announced. | Estimated window | Primary source |
| Early 2029 | $ATAI | ATAIBECKLEY INC | Topline data: BPL-003 (Phase 3). Company timing: Early 2029. Exact event day is not announced. | Estimated window | Primary source |
| H1 2029 | $LBRX | LB PHARMACEUTICALS INC | Topline data: LB-102 · adjunctive treatment of MDD (Phase 2). Company timing: H1 2029. Exact event day is not announced. | Estimated window | Primary source |
| 2029 | $NKTR | NEKTAR THERAPEUTICS | Target for the first rezpegaldesleukin BLA submission. This is company development guidance, not a scheduled FDA approval decision. Company timing: 2029. Exact event day is not announced. | Estimated window | Primary source |
| 2029 | $NUVB | NUVATION BIO INC | Clinical data readout: safusidenib · IDH1-mutant astrocytoma (pivotal Phase 3). Company timing: 2029. Exact event day is not announced. | Estimated window | Primary source |
| H2 2029 | $TARS | TARSUS PHARMACEUTICALS INC | Topline data: gildeuretinol (ALK-001) · Stargardt disease (Phase 3). Company timing: H2 2029. Exact event day is not announced. | Estimated window | Primary source |
| 2030 | $CELC | CELCUITY INC | Topline data: REVTORPYK (gedatolisib) · endocrine-sensitive HR+/HER2- ABC (Phase 3). Company timing: 2030. Exact event day is not announced. | Estimated window | Primary source |
| 2030 | $REPL | REPLIMUNE GROUP INC | RP1 (vusolimogene oderparepvec) plus nivolumab: primary overall-survival readout from Phase 3 IGNYTE-3 is expected in 2030. The trial compares the combination with physician's choice in advanced melanoma after anti-PD-1 and anti-CTLA-4 therapies or when anti-CTLA-4 is unsuitable. The H2 2027 interim OS analysis is a separate milestone. Company timing: 2030. Exact event day is not announced. | Estimated window | Primary source |
| 2030 | $XERS | XERIS BIOPHARMA HOLDINGS INC | XP-8121: potential FDA approval and commercial launch in 2030 are long-range company projections, conditional on trial outcomes and regulatory review; no assigned PDUFA date. Company timing: 2030. Exact event day is not announced. | Estimated window | Primary source Supporting source |
Recent history: 223 events
The following rows record completed events and dates that have passed. A past date does not prove an outcome or that a scheduled presentation occurred; uncertain status is stated in each row.
| Date / window | Ticker | Company | Event | Status | Sources |
|---|---|---|---|---|---|
| 2026-10-22 | $VERA | Vera Therapeutics, Inc. | The ORIGIN 3 final efficacy analysis of TRUTAKNA (atacicept-vymj) in adults with primary IgA nephropathy was presented on October 22, 2026 as a featured late-breaking oral in the opening plenary of ASN Kidney Week 2026 and published the same day in The New England Journal of Medicine. According to the company, TRUTAKNA achieved statistical significance on all prespecified endpoints, including eGFR change from baseline and annualized slope and risk reduction in composite kidney disease progression events. Adverse events occurred in 160/214 patients (75%) on TRUTAKNA and 167/214 (78%) on placebo; serious adverse events in 7% versus 15%. Vera plans to submit the supplemental BLA in Q4 2026, with potential full approval expected in 2027. | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-22 | $SGMT | Sagimet Biosciences Inc. | Sagimet announced that the first patient has been dosed in AURORA (NCT07863193), its pivotal U.S. Phase 3 trial of once-daily oral denifanstat 50 mg in moderate to severe acne. The randomized, double-blind, placebo-controlled trial is designed to enroll approximately 800 patients aged 12 and older, about 450 of them adolescents, with a 12-week double-blind period followed by a 40-week open-label extension; it is intended to support a potential U.S. NDA. Topline results are expected in the second half of 2027. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-22 | $OCS | Oculis Holding AG | Oculis released on October 22, 2026 the late-breaking Phase 2 ACUITY biomarker data on privosegtor in optic neuritis presented at the 10th Joint ACTRIMS-ECTRIMS Meeting (MSToronto 2026). Increases in plasma neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) were reduced with privosegtor versus placebo, particularly at early timepoints after acute onset: at Day 5 the mean increases in both markers were higher in the placebo group; NfL remained stable in the privosegtor group through Month 6, and GFAP remained below baseline in the privosegtor group from Month 1 through Month 6 while it stayed above baseline with placebo. The company presents these as biomarker findings complementing the previously reported visual and retinal results. | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-22 | $CGTX | Cognition Therapeutics, Inc. | Cognition Therapeutics announced alignment with the FDA on key elements of a pivotal Phase 3 study of zervimesine (CT1812) in dementia with Lewy bodies, including patient selection, dose, duration and endpoints. The planned registrational study is expected to enroll participants with mild-to-moderate DLB randomized to 100 mg once-daily oral zervimesine or placebo for nine months; the primary endpoint will be the NPI-2 measure of hallucinations and delusions, with ADCS-ADL as a key secondary endpoint. The company is completing the protocol; no start date was announced. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-22 | $ABUS | Arbutus Biopharma Corporation | Arbutus announced that the FDA notified the company that the clinical hold on the IND application for AB-101, its oral PD-L1 inhibitor for chronic hepatitis B, has been removed and that it may engage in additional clinical development of AB-101 in the United States. The company is evaluating next steps for the program. | HISTORICAL · Disclosed event | Primary source |
| October 17–21, 2026; ePoster day unspecified | $TLX | Telix Pharmaceuticals Limited | EANM 2026, 39th Annual Congress of the European Association of Nuclear Medicine (Vienna, October 17–21, 2026): ePoster EP-0460 with preliminary results from the Phase 3 trial of TLX591-Px (68Ga-PSMA-11; Illuccix) PET for detection of biochemical recurrence of prostate cancer in Chinese men (NCT05847348). The company release does not specify the ePoster day. | HISTORICAL · Outcome unverified | Primary source Supporting source |
| October 20–21, 2026 | $SVRA | Savara Inc. | CHEST 2026 (Phoenix): rapid-fire oral on long-term efficacy and safety of molgramostim in autoimmune pulmonary alveolar proteinosis from the IMPALA-2 open-label period on October 20, and a poster on patients with mild diffusion impairment on October 21. Encore and new analyses, not a new pivotal readout. The FDA target action date for the BLA is November 22, 2026. | HISTORICAL · Outcome unverified | Primary source Supporting source |
| 2026-10-21 | $SUPN | Supernus Pharmaceuticals, Inc. | Supernus announced that the FDA has recognized seven years of orphan-drug market exclusivity for ONAPGO (apomorphine HCl) for the treatment of motor fluctuations in adults with advanced Parkinson's disease. The seven-year exclusivity period began on February 3, 2025, the date of FDA approval. Separately, the company has submitted a supplemental NDA (sNDA) for a second manufacturing supplier for ONAPGO and continues to expect potential FDA approval of the second supplier by mid-year 2027 (unchanged from prior guidance). | HISTORICAL · Disclosed event | Primary source |
| 2026-10-21 | $ROIV | Roivant Sciences Ltd. | Roivant and its subsidiary Priovant Therapeutics announced positive topline results from the Phase 3 CLARITY-1 and CLARITY-2 trials of brepocitinib in non-infectious uveitis (NIU). Primary endpoint (time to treatment failure, assessed weeks 6-48) met with high statistical significance in both studies (p<0.0001). CLARITY-1 (n=166): hazard ratio 0.27 (95% CI 0.17-0.43); cumulative failure incidence at week 48 of 35.4% with brepocitinib versus 78.7% with placebo. CLARITY-2 (n=204): hazard ratio 0.22 (95% CI 0.14-0.34); cumulative failure incidence at week 48 of 32.4% versus 77.8%. Median time to treatment failure exceeded 48 weeks with brepocitinib versus approximately 12 weeks with placebo in both studies. Pooled steroid-free quiescence at week 48: 62% with brepocitinib versus 20% with placebo (p<0.0001). Key secondary endpoints (angiographic response, macular edema resolution, patient-reported visual function) also reached statistical significance. Safety data were consistent with prior brepocitinib clinical trials; no new safety signals. Brepocitinib is already approved in the U.S. for dermatomyositis under the brand name LISRAYA. Priovant intends to file a supplemental NDA for brepocitinib in NIU in the first half of calendar year 2027. | HISTORICAL · Disclosed event | SEC filing SEC filing |
| October 21, 2026 | $KYTX | Kyverna Therapeutics, Inc. | KYSA-8 Phase 2 miv-cel full one-year dataset in stiff person syndrome: MSToronto poster P0364, October 21, 4:30–6:30 p.m. ET. Presentation of follow-up data; the September 24 topline remains a separate historical event. | HISTORICAL · Outcome unverified | Primary source Supporting source |
| 2026-10-21 | $CRDF | Cardiff Oncology, Inc. | The FDA granted Orphan Drug Designation to onvansertib, Cardiff Oncology's oral PLK1 inhibitor, for the treatment of chronic myelomonocytic leukemia (CMML). Early investigator-initiated Phase 1 data presented at ASH 2025 showed preliminary efficacy in RAS-pathway-mutated CMML patients (40-50% of the myeloproliferative subtype), including a 100% platelet response, white blood cell normalization, a splenic response and a reduction in marrow blasts from 8% to 2% that enabled an allogeneic stem cell transplant in one patient. Onvansertib's lead program remains a planned registration-enabling first-line study in RAS-mutated metastatic colorectal cancer (mCRC) at the 30 mg dose, in combination with FOLFIRI/bevacizumab. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-21 | $CRDF | Cardiff Oncology, Inc. | The FDA granted Orphan Drug Designation to onvansertib, Cardiff Oncology's oral PLK1 inhibitor, for the treatment of chronic myelomonocytic leukemia (CMML). Early investigator-initiated Phase 1 data presented at ASH 2025 showed preliminary efficacy in RAS-pathway-mutated CMML patients (40-50% of the myeloproliferative subtype), including a 100% platelet response, white blood cell normalization, a splenic response and a reduction in marrow blasts from 8% to 2% that enabled an allogeneic stem cell transplant in one patient. Onvansertib's lead program remains a planned registration-enabling first-line study in RAS-mutated metastatic colorectal cancer (mCRC) at the 30 mg dose, in combination with FOLFIRI/bevacizumab. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-21 | $TGTX | TG Therapeutics, Inc. | TG Therapeutics released its MSToronto2026 posters on October 21, 2026, including seven-year ULTIMATE I/II follow-up and an ENABLE real-world update for BRIUMVI (ublituximab-xiiy) in relapsing MS. At seven years, 88.3% of patients on continuous BRIUMVI treatment remained free from 24-week confirmed disability progression; 11.7% progressed versus 17.4% in the switch group, patients who initially received teriflunomide before switching to BRIUMVI (p=0.0148), and 17.6% achieved confirmed disability improvement versus 13.6% in the switch group (p=0.0492). This comparison is not randomized and the p-values are nominal. The annualized relapse rate in Year 7 was 0.018, and the company reported no apparent increase in exposure-adjusted adverse event rates over time. In the Phase 4 observational ENABLE study (updated analysis of 1,076 participants), 99.2% remained relapse-free during treatment (ARR 0.014) and first-dose infusion-related reactions occurred in 18.8%. | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-21 | $TGTX | TG Therapeutics, Inc. | Phase 3 ENHANCE data on a single BRIUMVI initiation dose were released with the MSToronto2026 posters on October 21, 2026, ahead of the October 22 poster session. The trial met its primary endpoint, demonstrating bioequivalent drug exposure between the approved initiation regimen (150 mg on Day 1 and 450 mg on Day 15) and a consolidated single 600 mg infusion on Day 1, eliminating the need for a Day 15 infusion. Infusion-related reactions were comparable between regimens and lower than those reported in the ULTIMATE studies, with no Grade 3 or higher reactions in any participant. The company describes the single-dose initiation schedule as proposed. | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-21 | $TGTX | TG Therapeutics, Inc. | TG Therapeutics released its MSToronto2026 ePoster data on October 21, 2026. Phase 1 pharmacokinetics: subcutaneous BRIUMVI showed mean bioavailability above 60% relative to IV, and the company says PK modeling and simulation informed by these data support the quarterly subcutaneous regimen being evaluated in its fully enrolled Phase 3 trial, whose topline remains a separate future event. Switching analyses in the ENHANCE study: among participants who reported wearing-off on ocrelizumab, switching to BRIUMVI was associated with a 69% reduction in reported wearing-off at Week 24, sustained through Week 48; among participants not B-cell depleted when switching from a prior anti-CD20 antibody, 100% achieved B-cell depletion at Week 24 and 92.6% remained depleted at Week 48. BRILL, a non-interventional real-world study sponsored by Neuraxpharm (48-week interim analysis of 169 patients): the proportion of patients with a relapse decreased by 93% versus the 12 months before starting BRIUMVI, with an on-treatment ARR of 0.05. | HISTORICAL · Disclosed event | Primary source Supporting source |
| early 2027 | $NKTR | Nektar Therapeutics | Planned registrational Phase 3 rezpegaldesleukin study initiation in alopecia areata, expected in early 2027 (company guidance of August 13, 2026). Replaced by the ZENITH AA entry after the company's October 1, 2026 release. | HISTORICAL · Superseded estimate | SEC filing |
| 2026-10-21 | $IMUX | Immunic, Inc. | MSToronto2026 poster P0387 (Poster Session 1, October 21, 2026, 4:30–6:30 p.m. ET), disclosed by the company on October 21: in the open-label extension of the Phase 2 CALLIPER trial in progressive MS, the favorable trends on disability outcomes seen in the double-blind period were maintained among participants who continued vidofludimus calcium; 6.5% of patients discontinued through the January 27, 2026 data cutoff, and safety and tolerability appeared consistent with the double-blind period. Among the 387 participants who entered the extension, 44.4% had at least one treatment-emergent adverse event and 5.7% a serious one. CALLIPER did not meet its primary endpoint of percent brain volume change. | HISTORICAL · Disclosed event | Primary source Supporting source Supporting source |
| 2026-10-21 | $IMUX | Immunic, Inc. | MSToronto2026 ePosters EP2473 and EP2205 (on display for the duration of the congress), disclosed by the company on October 21, 2026. Exploratory CALLIPER analysis: vidofludimus calcium reduced EBV-specific T-cell receptor (TRB) sequence matches versus placebo (-0.65; p=0.0004), with influenza A-specific matches unchanged (+0.08; p=0.5983); in a post-hoc analysis, reductions were associated with improved SDMT scores. Post-hoc analysis with proposed bidirectional disability measures: 2.47 times higher likelihood of 24-week confirmed disability improvement (nominal p=0.037), positive confirmed disability change (nominal p=0.042), and 1.5 times higher likelihood of a better outcome by generalized pairwise comparisons (p=0.042). Exploratory and post-hoc analyses of a Phase 2 trial that missed its primary endpoint. | HISTORICAL · Disclosed event | Primary source Supporting source Supporting source |
| 2026-10-21 | $BCRX | BioCryst Pharmaceuticals, Inc. | The FDA approved BioCryst's sNDA for the 150 mg oral pellet formulation of once-daily ORLADEYO (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema in adults and adolescents aged 12 years and older, announced October 21, 2026. Patients can now take ORLADEYO in capsule or pellet form; the pellet formulation had been approved in December 2025 for patients aged 2 to under 12. The approval was based on chemistry, manufacturing and controls information and on data showing the safety and tolerability of the pellets compared with the capsules. | HISTORICAL · Disclosed event | Finviz (news) |
| 2026-10-20 | $VCRE | VICORE PHARMA HOLDING AB | Vicore Pharma's CEO takes part in a panel at the Chardan Healthcare Conference in New York on October 20, 2026, 2:00–2:30 p.m. ET. An investor conference appearance, not a data release. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-20 | $RCUS | ARCUS BIOSCIENCES INC | Arcus Biosciences disclosed new data from the ARC-20 platform study of casdatifan in clear cell renal cell carcinoma (ccRCC), data cutoff September 4, 2026. In second-line combination with cabozantinib (n=43, median follow-up 21.3 months): median progression-free survival 14.5 months, 18-month landmark overall survival 77%, confirmed objective response rate 44%. In a late-line monotherapy cohort pooling patients with one, two or three prior TKI-based therapies (n=121): median overall survival 35 months, median progression-free survival 13 months, confirmed objective response rate 36%. No unexpected safety signals were observed at the data cutoff. The release reports response, PFS and OS by cohort without a stated primary endpoint or a placebo/active comparator. | HISTORICAL · Disclosed event | SEC filing SEC filing |
| 2026-10-20 | $RCUS | ARCUS BIOSCIENCES INC | Arcus Biosciences disclosed new data from the ARC-20 platform study of casdatifan in clear cell renal cell carcinoma (ccRCC), data cutoff September 4, 2026. In second-line combination with cabozantinib (n=43, median follow-up 21.3 months): median progression-free survival 14.5 months, 18-month landmark overall survival 77%, confirmed objective response rate 44%. In a late-line monotherapy cohort pooling patients with one, two or three prior TKI-based therapies (n=121): median overall survival 35 months, median progression-free survival 13 months, confirmed objective response rate 36%. No unexpected safety signals were observed at the data cutoff. The release reports response, PFS and OS by cohort without a stated primary endpoint or a placebo/active comparator. | HISTORICAL · Disclosed event | SEC filing SEC filing |
| 2026-10-20 | $IONS | IONIS PHARMACEUTICALS INC | The FDA approved Hibsago (bepirovirsen), an antisense oligonucleotide GSK licensed from Ionis in 2019, for chronic hepatitis B in combination with nucleos(t)ide analogue reverse-transcriptase inhibitor (NrtI) therapy, announced October 20, 2026, ahead of the October 26, 2026 PDUFA date. Indication: adults without cirrhosis on NrtI therapy for at least 6 months, with suppressed HBV DNA and HBsAg ≤3,000 IU/mL by an FDA-authorized test. Treatment course is six months, with home administration possible after the first dose. In the pooled Phase 3 B-Well 1/2 data, 19% of participants (233 of 1,220) achieved functional cure — undetectable HBV DNA and HBsAg sustained for at least 24 weeks after stopping all treatment — versus 0% on placebo (0 of 614); the rate was 26% in the subgroup with baseline HBsAg ≤1,000 IU/mL. Labeled warnings include hepatic flares and thrombocytopenia, contraindicated below 100 x 10^9 platelets/L. | HISTORICAL · Disclosed event | Primary source Supporting source Supporting source Supporting source |
| 2026-10-20 | $HCM | Hutchmed | HUTCHMED's exclusive development and license agreement with a GSK subsidiary for HMPL-A830, a KRAS-EGFR antibody-targeted therapy conjugate (ATTC), closed on October 20, 2026, after customary closing conditions including antitrust review, following the agreement first announced September 3, 2026. The GSK subsidiary receives rights to develop and commercialize HMPL-A830 worldwide excluding mainland China, Hong Kong, Macau and Taiwan; HUTCHMED remains responsible for the global Phase Ia development program, initiated in September 2026 (NCT07718581). HUTCHMED expects to receive a $110 million upfront payment shortly, with up to $1.185 billion in additional development, regulatory and commercial milestones, plus tiered royalties on net sales. | HISTORICAL · Disclosed event | Finviz (news) |
| 2026-10-20 | $AAPG | ASCENTAGE PHARMA GROUP INTERNATIONAL | China's Center for Drug Evaluation (CDE), under the National Medical Products Administration (NMPA), granted Breakthrough Therapy Designation to Ascentage Pharma's lisaftoclax (APG-2575), the company's Bcl-2 inhibitor, in combination with acalabrutinib, for treatment-naive adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), announced October 20, 2026. Lisaftoclax was previously approved in China in July 2025 for CLL/SLL patients who had received at least one prior systemic therapy including a BTK inhibitor; the new designation applies specifically to the first-line combination evaluated in the global registrational Phase III trial GLORA-2. In the United States, lisaftoclax remains investigational and has not been approved by the FDA; the combination with acalabrutinib is investigational and not approved in any market. | HISTORICAL · Disclosed event | Primary source |
| October 20, 2026 | $RGNX | REGENXBIO Inc. | Sura-vec wet-AMD investor event on October 20, 1–4 p.m. ET, with clinical-program and retina-specialist discussion. The separate ATMOSPHERE/ASCENT pivotal topline remains guided for Q4 2026; this event is not the announced readout. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-20 | $IRD | Opus Genetics, Inc. | Opus Genetics presents at the Chardan Annual Healthcare Conference on Tuesday, October 20, 2026, at 10:00 a.m. ET, with a live and archived webcast. An investor conference appearance, not a data release. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-20 | $APMD | Apnimed, Inc. | CHEST 2026 (Phoenix, October 18–21): two late-breaking AD109 abstracts in obstructive sleep apnea on October 20, a rapid-fire oral on post-menopausal women and a poster on baseline hypoxic burden and blood-pressure response, plus a CHEST panel on the Phase 3 SynAIRgy and LunAIRo results. Analyses of already reported Phase 3 trials, not a new pivotal readout. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-20 | $ANAB | AnaptysBio | Post-trial hearing in GSK/Tesaro Jemperli litigation. Hearing date is not judgment date. | HISTORICAL · Outcome unverified | SEC filing |
| UEG Week 2026-10-17–2026-10-20 | $ABVX | ABIVAX SA | Conference presentation: obefazimod. Company timing: UEG Week 2026-10-17–2026-10-20. Congress: UEG Week. The conference range does not establish the individual presentation day. | HISTORICAL · Outcome unverified | SEC filing Supporting source |
| 2026-10-20 | $RAPP | RAPPORT THERAPEUTICS INC | Topline data announced: RAP-219 · acute bipolar mania (Phase 2, 253 adults). Primary endpoint met: 3.1-point placebo-adjusted improvement in YMRS total score at week 3 (p=0.045); secondary CGI-BP mania severity met (0.4 points, p=0.024). No serious adverse events during treatment; treatment discontinuation 24.6% on RAP-219 vs 11.8% on placebo. End-of-Phase 2 FDA meeting expected Q1 2027; two Phase 3 trials expected to start in H2 2027. | HISTORICAL · Disclosed event | SEC filing SEC filing SEC filing |
| 2026-10-19 | $SYRE | Spyre Therapeutics, Inc. | UEGW 2026 (Barcelona) moderated poster on Monday, October 19, 16:06-16:12 CEST (New Insights into IBD Biology (II), Hall 7, Poster Stage 2, presenter Andy Spencer): preclinical data in TNBS-induced colitis in humanized mice showing that anti-α4β7, anti-TL1A and anti-IL-23 are efficacious and that combinations further improve efficacy. Preclinical data, not a clinical readout. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-19 | $SLN | Silence Therapeutics plc | Merck KGaA, Darmstadt, Germany, agrees to acquire Silence Therapeutics plc for $20.00 per ADS in cash (three ordinary shares per ADS), valuing the company at approximately $1.3 billion in equity value and $1.1 billion in enterprise value — a 130% premium to the October 16, 2026 close and an 82% premium to the 30-day volume-weighted average price of $10.99. Structured as a UK scheme of arrangement under Part 26 of the Companies Act 2006, unanimously approved by Silence's board; holders of about 14% of voting rights have signed a voting and support agreement in favor of the transaction. Closing is subject to shareholder approval, sanction by the High Court of Justice of England and Wales, and customary regulatory approvals, expected to complete in Q1 2027. | HISTORICAL · Disclosed event | SEC filing SEC filing |
| 2026-10-19 | $SLN | Silence Therapeutics plc | Merck KGaA, Darmstadt, Germany, agrees to acquire Silence Therapeutics plc for $20.00 per ADS in cash (three ordinary shares per ADS), valuing the company at approximately $1.3 billion in equity value and $1.1 billion in enterprise value — a 130% premium to the October 16, 2026 close and an 82% premium to the 30-day volume-weighted average price of $10.99. Structured as a UK scheme of arrangement under Part 26 of the Companies Act 2006, unanimously approved by Silence's board; holders of about 14% of voting rights have signed a voting and support agreement in favor of the transaction. Closing is subject to shareholder approval, sanction by the High Court of Justice of England and Wales, and customary regulatory approvals, expected to complete in Q1 2027. | HISTORICAL · Disclosed event | SEC filing SEC filing |
| 2026-10-19 | $LLY | Eli Lilly and Company | Lilly reports one-year Phase 3 SHINE-2 results for Omvoh (mirikizumab-mrkz) in pediatric ulcerative colitis: the trial met its primary endpoint, with 50% of Week-12 responders (n=52 of 63 enrolled patients aged 4-17) in clinical remission at Week 52. Lilly describes it as the first IL-23p19 inhibitor to report one-year Phase 3 data in this pediatric population. Safety through Week 52 was consistent with the known adult profile, with no new signals; serious adverse events in 6.3% of patients, none treatment-related; no deaths, malignancies, opportunistic infections or growth issues reported. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-19 | $GSK | GSK plc | FDA grants accelerated approval to Jemperli (dostarlimab) monotherapy for adults with stage II/III dMMR/MSI-H locally advanced rectal cancer, based on the single-arm Phase 2 AZUR-1 study: 68% sustained clinical complete response at 12 months in the investigator assessment (98/144 evaluable patients); 47% in the independent central review (54/116), data still maturing. First and only immunotherapy approved in the US for this indication; accelerated approval, continued approval may depend on a confirmatory trial. Serious adverse reactions in 20% of patients. Full AZUR-1 interim data to be presented at ESMO 2026. Sources: SEC 6-K and company press release. | HISTORICAL · Disclosed event | SEC filing Supporting source |
| October 19, 2026 | $EPRX | Eupraxia Pharmaceuticals Inc. | UEG oral abstract: histopathological changes in eosinophilic esophagitis after a single EP-104GI administration during Phase 1b/2 RESOLVE dose escalation, October 19. Separate endpoint from dysphagia posters; not randomized Phase 2b interim data. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-19 | $TLX | Telix Pharmaceuticals Limited | EANM 2026, 39th Annual Congress of the European Association of Nuclear Medicine (Vienna), October 19, 2026, 16:45–18:15 CEST: oral presentation (abstract OP-523, presenter Yehia Omar, Misr Radiology) of interim results from the PTherpan-Lu trial of TLX597-Tx ([177Lu]Lu-panPSMA) radionuclide therapy for patients with mCRPC (also known as mAPMR, metastatic androgen pathway modulation-resistant prostate cancer). | HISTORICAL · Outcome unverified | Primary source Supporting source |
| 2026-10-19 | $TLX | Telix Pharmaceuticals Limited | EANM 2026, 39th Annual Congress of the European Association of Nuclear Medicine (Vienna), October 19, 2026, 08:00–09:30 CEST: oral presentation (abstract OP-312, presenter Nelleke Tolboom, UMC Utrecht) on IPAX BrIGHT, the pivotal study of TLX101-Tx (iodofalan-131I) with or without lomustine vs lomustine alone in patients with radiographically confirmed recurrent glioblastoma at first recurrence (NCT07100730). | HISTORICAL · Outcome unverified | Primary source Supporting source |
| 2026-10-18 | $TLX | Telix Pharmaceuticals Limited | EANM 2026, 39th Annual Congress of the European Association of Nuclear Medicine (Vienna), October 18, 2026, 15:00–16:30 CEST: oral presentation (abstract OP-170, presenter Ghoufrane Tlili, CHU Bordeaux) on LUTEON, the Phase 3 study to assess safety and efficacy of TLX250-Tx (177Lu-girentuximab) in advanced, relapsed or recurrent clear cell renal cell carcinoma (ccRCC) (NCT07197580). | HISTORICAL · Outcome unverified | Primary source Supporting source |
| 2026-10-19 | $MANE | VERADERMICS INC | Part A of Phase 3 Study '304' (536 men with mild-to-moderate pattern hair loss, VDPHL01 8.5 mg once or twice daily vs placebo) met all primary and secondary endpoints. Mean increase in non-vellus target area hair count at Month 6: 28.6 hairs/cm² (once daily) and 36.4 hairs/cm² (twice daily) vs 6.6 with placebo (p<0.0001); 55.7% and 68.7% reported 'improved' or 'much improved' hair coverage vs 15.0% with placebo (p<0.0001). No treatment-related serious adverse events and no adverse events of special interest of cardiac origin. Veradermics anticipates Part B data from Study '302' later in 2026 and Study '306' (women) topline in the first half of 2027. Topline announced October 19, 2026. | HISTORICAL · Disclosed event | Primary source SEC filing Supporting source SEC filing |
| 2026-10-19 | $IRON | DISC MEDICINE INC | APOLLO Phase 3 (183 adults and adolescents aged 12 or older with EPP or XLP, bitopertin 60 mg once daily vs placebo, 1:1, 6 months) met both co-primary endpoints: whole-blood metal-free PPIX reduction of -41.4% vs placebo (p<0.0001) and +12.2 hours of average monthly total time in light without pain during month 6 vs placebo (p=0.0010). All secondary endpoints were statistically significant, including fewer phototoxic reactions (p<0.0001). Dizziness was the most common adverse event (50%), mild or moderate; no adverse events above Grade 3. Disc plans to resubmit the NDA to the FDA by the end of 2026, with an FDA decision anticipated by mid-2027. Topline announced October 19, 2026. | HISTORICAL · Disclosed event | Primary source SEC filing Supporting source SEC filing |
| 2026 | $KRYS | KRYSTAL BIOTECH INC | Interim data: KB707 · Gorlin syndrome (Phase 1/2). Company timing: 2026. Exact event day is not announced. | HISTORICAL · Superseded estimate | SEC filing Trial registry |
| 2026-10-16 | $OMER | Omeros Corporation | The EMA's CHMP maintained its negative opinion on the marketing authorization application for narsoplimab in transplant-associated thrombotic microangiopathy (TA-TMA) following re-examination, announced October 16, 2026. According to Omeros, an eight-member ad hoc expert group (AHEG) consisting of hematologists, statisticians, and transplant physicians, together with two patient representatives, was convened by the CHMP to address a single, three-part question posed by the CHMP, and recommended a review of individual patient-level data by external experts; Omeros states it submitted detailed patient-level data in August 2026 but that the CHMP did not provide it to the AHEG. Omeros said it does not expect routine access in Europe and is working toward reimbursed named-patient access where permitted, and separately notified the CHMP of its intent to close the compassionate-use program for the drug (U.S. brand name YARTEMLEA) due to rising commercial-supply demand in the United States; patients already on therapy are to receive enough drug to complete their courses. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-16 | $IBRX | IMMUNITYBIO, INC. | ImmunityBio reported long-term Phase 2/3 QUILT-3.032 data for ANKTIVA (nogapendekin alfa inbakicept-pmln) plus BCG in BCG-unresponsive NMIBC with CIS, with or without papillary tumors: 84% cystectomy-free survival at 36 months among responders, 71% overall complete response rate, median complete-response duration 26.6 months with responses extending beyond 53 months; published in the Journal of Urology, announced October 16, 2026. This is a long-term follow-up analysis, distinct from the FDA's October 2026 approval of the expanded papillary-only indication already in this catalog. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-15 | $LEGN | Legend Biotech Corporation | The FDA cleared Legend Biotech's IND application for LB2501, an investigational in vivo CD19/CD20 CAR-T therapy built on the TaVec lentiviral platform and being evaluated without lymphodepleting chemotherapy, for relapsed or refractory B-cell malignancies including B-cell non-Hodgkin lymphoma, announced October 15, 2026. A planned US Phase 1/2 study will evaluate safety, tolerability, pharmacokinetics and preliminary efficacy; no start date disclosed. This is distinct from the ongoing Phase 1 study of the same product in China (NCT07002112) already tracked in this catalog. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-15 | $KRYS | KRYSTAL BIOTECH INC | Krystal Biotech reported positive proof-of-concept data for KB113 (low-dose intratumoral KB707, delivering IL-2/IL-12) in three adult patients with Gorlin syndrome basal cell carcinomas, announced October 15, 2026: 83.1% of assessed lesions showed clinical regression (69 of 83), with biopsied lesions showing histologically confirmed complete response. The company has begun FDA discussions on advancing KB113's clinical development. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-13 | $BEAM | BEAM THERAPEUTICS INC | Beam Therapeutics announced initial Phase 1/2 data for BEAM-301 in glycogen storage disease type Ia (GSDIa): as of the June 26, 2026 data cutoff, six patients had received a single intravenous infusion of BEAM-301 (three at 20 mg, three at 40 mg); median follow-up was 313 days (range, 249–453) in the 20 mg cohort and 53 days (range, 5–110) in the 40 mg cohort, and one patient in the 40 mg cohort was not evaluable for efficacy as of the cutoff. Safety: all patients experienced at least one treatment-emergent adverse event considered related to BEAM-301; five serious adverse events were reported and resolved within two to 10 days, including three Grade 3 infusion-related reactions; all transaminase elevations were transient and resolved without intervention and, except for a single Grade 2 AST elevation, were Grade 1; no dose-limiting toxicities, treatment discontinuations due to treatment-emergent adverse events, or deaths were reported. Efficacy: median time to fasting hypoglycemia at baseline was 2.9 hours in the 20 mg cohort and 2.5 hours in the 40 mg cohort; by Day 36 it increased to 4.3 hours in the 20 mg cohort, while both evaluable patients in the 40 mg cohort achieved the protocol-defined maximum controlled fasting duration of ≥15 hours. Decreases from baseline in prescribed daily starch intake were 74% (Day 128), 71% (Day 227) and 11% (Day 387) in the 20 mg cohort and 71% (Day 50) and 92% (Day 93) in the 40 mg cohort; triglyceride levels were comparable to baseline at last follow-up. The data will be presented as a poster at the ESGCT 33rd Annual Congress on October 28, 2026. | HISTORICAL · Disclosed event | Primary source SEC filing |
| 2026-10-13 | $RYTM | RHYTHM PHARMACEUTICALS, INC. | Rhythm Pharmaceuticals announced the commercial launch of IMCIVREE (setmelanotide) in Japan for patients with acquired hypothalamic obesity, following the drug's inclusion on Japan's National Health Insurance drug price list; the company says IMCIVREE is the first approved therapy in Japan for this indication. Japan's Ministry of Health, Labour and Welfare approved IMCIVREE for acquired hypothalamic obesity in August 2026, based on the Phase 3 TRANSCEND trial (142 patients, including a Japanese cohort), which met its primary endpoint with an 18.8% placebo-adjusted reduction in BMI; setmelanotide also holds MHLW orphan drug designation for this indication. Rhythm estimates approximately 5,000 to 8,000 people live with acquired HO in Japan. | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-18 | $GSK | GSK plc | GSK announced the first global data for risvutatug rezetecan (Ris-Rez), its investigational B7-H3-targeted antibody-drug conjugate, in relapsed extensive-stage small cell lung cancer, from the Phase Ib dose-optimisation portion of EMBOLD PanTumour-101 (NCT06551142), announced October 18, 2026. Confirmed objective response rate was 61% at 8 mg/kg (11/18 evaluable patients; 95% CI: 35.7-82.7) and 32% at 6 mg/kg (7/22; 95% CI: 13.9-54.9); grade 3 or higher treatment-related adverse events occurred in 42% of patients at 8 mg/kg and 15% at 6 mg/kg, mostly haematological; interstitial lung disease occurred in 1 of 50 patients (grade 2). Median follow-up was 100.5 days. The findings will be presented in a poster session at the ESMO Congress 2026 in Madrid. The 8 mg/kg dose is being evaluated in the global Phase III EMBOLD SCLC-301 study. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-18 | $SYRE | Spyre Therapeutics, Inc. | UEGW 2026 (Barcelona) oral presentation on Sunday, October 18, 15:30-15:40 CEST (Hot Topics in IBD, Room B3, presenter Silvio Danese): efficacy and safety of the half-life extended antibodies SPY001 (anti-α4β7), SPY002 (anti-TL1A) and SPY003 (anti-IL-23) for induction treatment of moderately to severely active ulcerative colitis, the company's first scientific congress presentation of clinical data across all three IBD antibodies. The company release does not report efficacy figures; the SKYLINE combination results are a separate, later milestone. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-15 | $LLY | Eli Lilly and Company | On October 15, 2026, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorisation for Foundayo (orforglipron), a GLP-1 receptor agonist, applicant Eli Lilly Nederland B.V. Indications: as an adjunct to healthy diet and physical activity for weight management, including weight loss and weight maintenance, in adults with an initial BMI of ≥ 30 kg/m2 (obesity), or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) with at least one weight-related comorbidity; and for adults with insufficiently controlled type 2 diabetes, as monotherapy when metformin is considered inappropriate or in combination with other diabetes medicines. Film-coated tablets of 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg and 17.2 mg. The final decision rests with the European Commission; no timeline disclosed. | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-15 | $JSPR | Jasper Therapeutics, Inc. | Jasper Therapeutics completed enrollment of the IgA nephropathy (IgAN) cohort of its Phase 2 renal basket study evaluating vensobafusp alfa (KP104), announced October 15, 2026 via Form 8-K. The filing discloses the enrollment milestone only; it does not give a specific date for the next data readout. | HISTORICAL · Disclosed event | SEC filing |
| 2026-10-16 | $VTRS | Viatris Inc. | FDA approved RYZUMVI (phentolamine ophthalmic solution 0.75%) for presbyopia in adults, announced October 16, 2026. The decision is based on the Phase 3 VEGA-2 and VEGA-3 trials, which met the primary endpoint and all key secondary endpoints with no serious treatment-related adverse events; the most common adverse reactions in the presbyopia trials were conjunctival hyperemia (21%) and instillation-site irritation (16%). RYZUMVI was already approved for pharmacologically induced mydriasis in adults and in pediatric patients 3 years of age and older. Opus Genetics (IRD) and Viatris (VTRS) share a global license agreement for the product; Viatris holds exclusive U.S. commercialization rights, and the approval triggers a milestone payment to Opus Genetics. Sources: https://investor.viatris.com/news-releases/news-release-details/viatris-receives-us-fda-approval-ryzumvir-treatment-presbyopia ; https://www.globenewswire.com/news-release/2026/10/16/3382714/0/en/opus-genetics-announces-fda-approval-of-phentolamine-ophthalmic-solution-0-75-for-the-treatment-of-presbyopia.html | HISTORICAL · Disclosed event | Primary source Supporting source Supporting source Supporting source |
| 15–16 October 2026 | $TSHA | TAYSHA GENE THERAPIES INC | TSHA-102 REVEAL Part A Phase 1/2 safety and efficacy results in Rett syndrome: encore oral and poster presentations on October 15 at the Child Neurology Society meeting. Company-hosted symposium on October 16. These sessions repeat previously shared IRSF data rather than announce a new readout. Company timing: 15–16 October 2026. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-16 | $RHHBY | Roche | FDA approved Enspryng (satralizumab) for thyroid eye disease (TED) in adults, announced October 16, 2026, as the first and only at-home subcutaneous treatment option for TED; the subcutaneous formulation can be self-administered or given by a caregiver after training by a healthcare provider. The approval followed Priority Review based on the Phase III SatraGO program (258 patients, 19 countries, 1:1 randomization against placebo): in the active-TED population, SatraGO-2 met its primary endpoint (proptosis response 52.9% with Enspryng vs 23.4% with placebo; diplopia response 60.7% vs 25.8%), while SatraGO-1 did not reach statistical significance on the prespecified primary endpoint at week 24. No new safety signals were identified; the safety profile was consistent with the drug's known profile in its first approved indication, neuromyelitis optica spectrum disorder (NMOSD, approved 2020). | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-16 | $REGN | Regeneron Pharmaceuticals, Inc. | The EMA's CHMP adopted a positive opinion recommending EU approval of an updated Libtayo (cemiplimab) dosing regimen across all approved cancer indications, announced October 16, 2026. After an initial 12-week cycle of 350 mg every three weeks (30-minute IV infusion), the recommended regimen is 700 mg every six weeks, also as a 30-minute infusion; a shorter 15-30 minute infusion option is also proposed for the 350 mg every-three-weeks dose once the first infusion has been well tolerated at 30 minutes. The 700 mg every-six-week regimen is already approved in the EU, but only for adjuvant treatment of high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiotherapy. This is a CHMP recommendation, not a final decision; European Commission approval is expected in the coming months. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-16 | $IONS | IONIS PHARMACEUTICALS INC | The EMA's CHMP adopted a positive opinion recommending EU approval of TRYNGOLZA (olezarsen) for adults with severe hypertriglyceridemia (sHTG, fasting triglycerides at or above 880 mg/dL), as an adjunct to diet and in combination with other lipid-lowering therapies, announced October 16, 2026. This is a CHMP recommendation, not a final decision; European Commission approval is expected in the fourth quarter of 2026. Ionis discovered and developed olezarsen and commercializes it in the United States; Sobi holds exclusive ex-U.S. commercialization rights (excluding Canada and China) under a license agreement with Ionis. The companies cite data from the Phase 3 CORE and CORE2 studies showing triglyceride reductions of up to 72% at six months and an 85% reduction in acute pancreatitis events versus placebo in the pooled analysis. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-16 | $ASND | Ascendis Pharma A/S | The EMA's CHMP adopted a positive opinion recommending EU marketing authorization for a once-weekly TransCon CNP (navepegritide) regimen for the treatment of achondroplasia in children, announced October 16, 2026. This is a CHMP recommendation, not a final decision; approval by the European Commission is a separate, later step. | HISTORICAL · Disclosed event | SEC filing |
| 2026-10-15 | $RVMD | Revolution Medicines, Inc. | The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending EU marketing authorization for RASONQUE (daraxonrasib), a once-daily oral RAS(ON) inhibitor, as monotherapy for adults with metastatic pancreatic adenocarcinoma who received at least one prior systemic therapy. Based on Phase 3 RASolute 302 (overall survival HR 0.40, median 13.2 vs 6.7 months; PFS HR 0.49, median 7.2 vs 3.6 months). Final authorization decision rests with the European Commission; no timeline disclosed. Follows the August 26, 2026 FDA approval. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-14 | $OPK | OPKO Health, Inc. | OPKO Health and subsidiary BioReference Health entered a definitive Asset Purchase Agreement, signed October 14, 2026, to sell select clinical and anatomic pathology laboratory testing assets (including women's health, urology, correctional-services testing and the proprietary 4Kscore prostate-cancer test) to Laboratory Corporation of America Holdings (Labcorp). Consideration: $722 million cash upfront at closing (subject to revenue-based adjustments) plus up to $150 million in earnouts over up to ten years tied to 4Kscore sales. Closing is subject to HSR Act clearance and customary conditions, with an outside date of April 14, 2027; the deal is not subject to a financing condition. | HISTORICAL · Disclosed event | SEC filing |
| End of November 2026 | $MLTX | MoonLake Immunotherapeutics | Sonelokimab HS BLA acceptance, Priority Review decision and PDUFA date allocation. Superseded by the BLA submission of September 30, 2026: the company said it expects to learn whether the BLA is accepted for review within about 60 days of submission and to receive the planned review timeline within about 74 days. As of October 15, 2026, MoonLake had not announced FDA acceptance of the BLA or a PDUFA date. | | HISTORICAL · Superseded estimate | Primary source Supporting source SEC filing |
| 2026-10-14 | $IBRX | IMMUNITYBIO, INC. | FDA approved the expanded indication for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with BCG, announced October 14, 2026, ahead of the January 6, 2027 target action date. The label now reads: indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer, adding papillary-only tumors to carcinoma in situ with or without papillary tumors. | HISTORICAL · Disclosed event | SEC filing Supporting source |
| 2026-10-14 | $TRDA | TRDA | Entrada reported ELEVATE-45-201 Cohort 1 results for ENTR-601-45 (5 mg/kg, three doses, eight participants randomized 3:1): favorable safety and tolerability; dystrophin +0.10 percentage points from baseline in treated participants versus -0.02 on placebo, exon skipping +0.15 versus -0.04. Cohort 2 (10 mg/kg) data are guided to H1 2027. | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-13 | $UTHR | UNITED THERAPEUTICS CORPORATION | United Therapeutics and Liquidia announced a global settlement resolving all pending patent, trade-secret and antitrust litigation between them over Liquidia's YUTREPIA and Treprostinil Injection. The settlement follows the September 30, 2026 ruling that claims 1 and 14 of United Therapeutics' U.S. Patent No. 11,826,327 are valid and infringed; Liquidia will not appeal and will pay United Therapeutics a net $175 million within 30 business days, plus two $72.7 million installments due January 31 and April 30, 2027 (total net payments of $380.7 million through 2026-2027, including $60.3 million paid in October 2026 to other antitrust-case parties). Liquidia is removing the PH-ILD indication from YUTREPIA's label and has ended its Treprostinil Injection promotional agreement; United Therapeutics retains the ability to assert its patents against Liquidia's other development programs or future products. | HISTORICAL · Disclosed event | Primary source |
| October 13, 2026 | $STRO | Sutro Biopharma, Inc. | World ADC plenary on the early clinical safety and pharmacokinetic profile of STRO-004, October 13 at 9:30 a.m. Pacific Time. Separate STRO-006 and STRO-227 presentations concern preclinical findings. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-13 | $LQDA | LIQUIDIA CORP | Liquidia and United Therapeutics announced a global settlement resolving all pending patent, trade-secret and antitrust litigation between them. Liquidia will not appeal the September 30, 2026 ruling that claims 1 and 14 of U.S. Patent No. 11,826,327 are valid and infringed, and will pay United Therapeutics a net $175 million within 30 business days, plus two $72.7 million installments due January 31 and April 30, 2027; a separate $60.3 million was paid in October 2026 to other parties in the related antitrust litigation, for net payments of $380.7 million through 2026-2027. YUTREPIA remains available without disruption for pulmonary arterial hypertension; Liquidia is removing the PH-ILD indication from YUTREPIA's label, has stopped promoting it for PH-ILD, and has ended its Treprostinil Injection promotional agreement. United Therapeutics retains the ability to assert its patents against Liquidia's other development programs or future products. | HISTORICAL · Disclosed event | Primary source |
| ECNP Congress 2026-10-10–2026-10-13 | $GHRS | GH RESEARCH PLC | Conference presentation: mebufotenin (GH001) · TRD Treatment-resistant depression (Phase 2b). Company timing: ECNP Congress 2026-10-10–2026-10-13. Congress: ECNP Congress. The conference range does not establish the individual presentation day. | HISTORICAL · Outcome unverified | SEC filing Trial registry Supporting source |
| 2026-10-13 | $GENB | GENERATE BIOMEDICINES INC | Generate Biomedicines and Zealand Pharma announced a collaboration and license agreement to develop AI-engineered multispecific protein therapeutics for obesity and other metabolic and cardiometabolic diseases, covering two initial programs with an option to add a third. Generate will lead research through lead-candidate selection using its generative AI platform; Zealand Pharma will lead clinical development, regulatory submissions and worldwide commercialization. Generate will receive a $30 million upfront payment, up to $35 million in early preclinical milestones, total milestones of nearly $1.2 billion across the programs, and tiered royalties on worldwide net sales of any resulting products. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-13 | $BMEA | Biomea Fusion, Inc. | Biomea Fusion reported Phase 1 results (study GLP-131, NCT07223216) for BMF-650, its investigational oral GLP-1 receptor agonist: mean weight reduction of 1.5%-3.2% by Day 29 across four multiple-ascending-dose cohorts versus 0.1% for pooled placebo, about 0.97 kg per week at once-daily doses of 200 mg or higher. A separate, confined fifth cohort (200 mg for one week, then 400 mg) showed a 6.1% (6.2 kg) mean reduction, about 1.55 kg per week; the company says this cohort should be read separately because confinement altered the placebo group's eating. All treatment-emergent adverse events across the 40 active-dose participants were mild or moderate, with no severe or serious TEAEs, dose modifications or discontinuations. The company plans to complete longer-term toxicology studies and pursue a strategic partnership before further clinical development; its primary pipeline focus remains icovamenib in diabetes. | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-13 | $ALEC | Alector, Inc. | Alector virtual R&D event October 13 at 8 a.m. PT covering ABC-enabled AL137, AL164, AL062 and ADP065. Preclinical pipeline discussion; no human efficacy readout is claimed. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-12 | $SNDX | Syndax Pharmaceuticals, Inc. | MAXPIRe Phase 2 (145 patients with idiopathic pulmonary fibrosis, axatilimab 0.3 mg/kg every two weeks vs placebo, 2:1) did not meet its primary endpoint, the annualized rate of decline in forced vital capacity. Safety was comparable to placebo with no new signals. Syndax does not plan further development of axatilimab in IPF; cGVHD trials continue. Topline announced October 12, 2026 after market close. | HISTORICAL · Disclosed event | Primary source Supporting source Supporting source SEC filing |
| 2026-10-12 | $REGN | Regeneron Pharmaceuticals, Inc. | Regeneron reported positive 84-week Phase 3 OPTIMA results for Pasatru (garetosmab-grts) in adults with fibrodysplasia ossificans progressiva at ASBMR: zero new heterotopic ossification lesions during the trial extension and sustained reduction in flare-ups, with a consistent safety profile from week 56 to 84. | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-12 | $NRIX | Nurix Therapeutics, Inc. | In its fiscal third-quarter update, Nurix discontinued further clinical development of NX-2127 (zelebrudomide) as part of a strategic prioritization of its wholly owned oncology portfolio; it also reported the first patient enrolled in the Phase 3 DAYBreak CLL-306 trial of bexobrutideg versus pirtobrutinib. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-12 | $JNJ | Johnson & Johnson | Johnson & Johnson announced TREMFYA Crohn's disease data being presented as posters at ACG 2026 on October 13: in the GALAXI 2 and 3 Week 144 long-term extension (as-observed analysis), clinical remission was 94% (100 mg q8w) and 91% (200 mg q4w) and endoscopic remission 52% and 61%; prespecified FUZION subgroup analyses in perianal fistula were consistent with the overall Week 24 combined fistula remission results (28% and 27% vs 10% with placebo). | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-12 | $EWTX | Edgewise Therapeutics, Inc. | Phase 1 healthy-adult data for EDG-15400 were scheduled for presentation at HFSA on October 12, 2026 (12:15–1:15 p.m. Mountain Time). These are not Phase 2 HFpEF efficacy results. | HISTORICAL · Outcome unverified | Primary source |
| October 12, 2026 | $EPRX | Eupraxia Pharmaceuticals Inc. | ACG poster on EP-104GI in the RESOLVE Phase 1b/2 trial, dysphagia improvements through 52 weeks, scheduled for October 12, 2026. The related UEG dysphagia poster on October 18 is a repeat presentation, not a second clinical readout. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-12 | $CYTK | CYTOKINETICS INC | Additional ACACIA-HCM analyses in non-obstructive HCM presented at HFSA 2026: at 36 weeks aficamten significantly improved the composite exercise score BEAP-RS versus placebo (p<0.001). Cytokinetics plans to submit a supplemental NDA this quarter. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-12 | $CSTL | Castle Biosciences, Inc. | Castle Biosciences announced data from three TissueCypher Barrett's esophagus studies (two case reports and one multicenter study) on molecular risk information beyond histopathology, presented as posters at ACG 2026 on October 12 and 13. Diagnostic-test data, not a drug trial. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-12 | $AVBP | ARRIVENT BIOPHARMA INC | ArriVent dosed the first U.S. patient in the Phase 1 trial of ARR-002 (NCT07755436), a MUC16/NaPi2b dual-target tetravalent antibody-drug conjugate for ovarian and endometrial cancer. The company has not disclosed timing for initial data. | HISTORICAL · Disclosed event | Primary source |
| October 12 announcement | $ZBIO | Zenas BioPharma, Inc. | Zenas announced new INDIGO Phase 3 extension and steroid-toxicity analyses in IgG4-related disease, presented at the October 8–10 symposium. Vaccine-response observations came from a small exploratory substudy, not a separate pivotal trial. | HISTORICAL · Disclosed event | Company release |
| 2026-10-12 | $TRAX | FIRST TRACKS BIOTHERAPEUTICS INC | ANB033 Phase 1b celiac-disease Cohort 1 gluten-challenge results showed statistically significant protection against intestinal damage and symptoms versus placebo. The placebo-adjusted villus-height/crypt-depth change was +0.49 (p=0.009). These are early-stage results in 32 patients, distinct from the pending mucosal-healing Cohort 2. | HISTORICAL · Disclosed event | Company release Supporting source |
| October 12 announcement | $TGTX | TG Therapeutics, Inc. | TG announced publication of a five-year matching-adjusted indirect comparison of BRIUMVI with ocrelizumab and ofatumumab in relapsing MS. Reported favorable associations are not evidence from a randomized head-to-head comparison. | HISTORICAL · Disclosed event | Company release |
| October 12 announcement | $STOK | Stoke Therapeutics, Inc. | Stoke disclosed ADOA natural-history and preclinical STK-002 findings at AAO. These support the ongoing OSPREY program; the separate initial safety and efficacy readout from cohorts 3 and 4 remains expected in H1 2027. | HISTORICAL · Disclosed event | Company release |
| October 12 announcement | $PVLA | PALVELLA THERAPEUTICS INC | Palvella disclosed new SELVA Phase 3 participant-interview and maximal-use pharmacokinetic analyses at Fall Clinical, alongside separate DSAP claims research. These are additional analyses, not a new pivotal efficacy readout. | HISTORICAL · Disclosed event | Company release |
| October 12 announcement | $PALI | Palisade Bio, Inc. | ACG disclosure of clinical, PK/PD and mechanistic findings from small, short, open-label ulcerative-colitis and fibrostenotic Crohn’s cohorts. The findings support Phase 2 investigation but do not establish efficacy in controlled trials. | HISTORICAL · Disclosed event | Company release |
| October 12 announcement | $NGEN | NervGen | NervGen announced the first participant dosed in RESTORE, a Phase 3 registrational study in chronic cervical motor-incomplete spinal cord injury. October 12 is the announcement date. | HISTORICAL · Disclosed event | Company release Trial registry |
| 2026-10-12 | $MIRM | Mirum Pharmaceuticals, Inc. | LIVMARLI EXPAND Phase 3 met its primary pruritus endpoint and all five prespecified secondary endpoints in ultra-rare cholestatic liver diseases. In the pediatric primary analysis, the placebo-adjusted pruritus improvement was 0.98 points (p=0.0004). Results announced October 12, 2026. | HISTORICAL · Disclosed event | Primary source Company release Supporting source |
| October 12 announcement | $CRVO | CervoMed Inc. | CervoMed announced initial 12-week open-label nfvPPA biomarker findings presented at ISFTD. Mean plasma NfL declined; GFAP was stable. Biomarker changes in this small uncontrolled period do not establish clinical benefit. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-12 | $BMY | BRISTOL MYERS SQUIBB | The planned ACTION-1 Phase 3 interim analysis met the progression-free-survival primary endpoint in SSTR-positive GEP-NETs progressing after Lu177-based therapy. Overall-survival follow-up continues; detailed results will be presented at a future medical meeting with no date specified. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-12 | $BMY | BRISTOL MYERS SQUIBB | ALOFT-IPF Phase 3 met its Week 52 forced-vital-capacity primary endpoint with admilparant 60 mg twice daily versus placebo. The 120 mg twice-daily arm was not statistically significant. Regulatory discussions and detailed presentation are planned without a disclosed date. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-11 | $PHAT | Phathom Pharmaceuticals, Inc. | ACG poster P0624, 3:30–7 p.m. CDT: post-hoc BMI analysis of vonoprazan efficacy in non-erosive GERD. Exploratory analysis, not a new pivotal trial result. | HISTORICAL · Outcome unverified | Primary source |
| October 8–11, 2026 | $LLY | Eli Lilly and Company | New Fall Clinical dermatology findings include Phase 3 ADorable-1 pediatric lebrikizumab data and TOGETHER-PsO analyses. October 8–11 is the conference window; individual poster days are not provided. | HISTORICAL · Outcome unverified | Primary source |
| October 11, 2026 | $BMRN | BioMarin Pharmaceutical Inc. | ASBMR poster 483, October 11 at 2:00-3:30 p.m. EDT: new post-hoc VOXZOGO imaging analysis of foramen magnum and craniocervical junction growth in children with achondroplasia. Scheduled clinical presentation; no inference of completed presentation from calendar date. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-11 | $BBIO | BridgeBio Pharma, Inc. | CALIBRATE Phase 3 ASBMR analyses reported increased bone-turnover markers and restoration of endogenous PTH with encaleret in ADH1. These are additional analyses of the trial, not a new pivotal topline. | HISTORICAL · Disclosed event | Company release Supporting source |
| 2026-10-11 | $BBIO | BridgeBio Pharma, Inc. | CALIBRATE patient-reported ASBMR analyses found improvement in at least one ADH1 symptom in 100% of encaleret participants versus 46% on standard care. The analysis is distinct from the bone-turnover presentation. | HISTORICAL · Disclosed event | Company release Supporting source |
| 2026-10-11 | $BBIO | BridgeBio Pharma, Inc. | Independent Epic COSMOS observational ATTR-CM analysis presented at HFSA found acoramidis associated with lower risk of the composite clinical endpoint than tafamidis. This is real-world comparative evidence, not a randomized head-to-head trial. | HISTORICAL · Disclosed event | Company release Supporting source |
| October 11 announcement | $BBIO | BridgeBio Pharma, Inc. | BridgeBio announced the first participant dosed in RECLAIM-HP Phase 3 in chronic hypoparathyroidism. This program is separate from the ADH1 CALIBRATE trial and the existing May 8, 2027 ADH1 PDUFA target. | HISTORICAL · Disclosed event | Company release Trial registry |
| 8–11 October 2026 | $ATTO | ATTOVIA THERAPEUTICS INC | ATTO-1310 Phase 1b interim efficacy and safety poster in atopic dermatitis or chronic pruritus at Fall Clinical Dermatology Conference. The EADV posters concern separate healthy-volunteer and translational datasets. Company timing: 8–11 October 2026. Congress: Fall Clinical Dermatology Conference 2026. The conference range does not establish the individual presentation day. | HISTORICAL · Outcome unverified | Primary source |
| 8–11 October 2026 | $ATTO | ATTOVIA THERAPEUTICS INC | Preclinical characterization of ATTO-2306, a long-acting bispecific antibody targeting IL-13 and IL-31, presented at Fall Clinical Dermatology Conference. Company timing: 8–11 October 2026. Congress: Fall Clinical Dermatology Conference 2026. The conference range does not establish the individual presentation day. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-10 | $BBIO | BridgeBio Pharma, Inc. | ATTRibute-CM sub-analyses presented at HFSA assessed cardiovascular hospitalization burden and mortality. The October 11 release confirms presentation; the previously scheduled session was October 10. | HISTORICAL · Disclosed event | Company release Supporting source |
| 2026-10-09 | $ANIP | ANI PHARMACEUTICALS INC | SYNCHRONICITY Phase 4 open-label, single-arm data were presented at AAO on October 9 and announced October 12. Both six-month co-primary endpoints were met; functional and anatomic improvements were generally maintained at 24 months. There was no randomized comparator. | HISTORICAL · Disclosed event | Company release Supporting source Supporting source |
| August 2026 | $PVLA | PALVELLA THERAPEUTICS INC | Palvella completed the rolling NDA submission for QTORIN rapamycin in microcystic lymphatic malformations in August 2026, as stated in its October 12 release. The source specifies the month, not the completion day. | HISTORICAL · Disclosed event | Company release Supporting source |
| 2025-11-21 | $PFE | Pfizer Inc. | FDA approved perioperative Padcev with Keytruda or Keytruda Qlex for adults with muscle-invasive bladder cancer ineligible for cisplatin on November 21, 2025, ahead of the former April 7, 2026 target. This is the KEYNOTE-905/EV-303 indication. | HISTORICAL · Disclosed event | Primary source Supporting source Supporting source |
| 2025-11-21 | $MRK | Merck & Co., Inc. | FDA approved perioperative Padcev with Keytruda or Keytruda Qlex for adults with muscle-invasive bladder cancer ineligible for cisplatin on November 21, 2025, ahead of the former April 7, 2026 target. This is the KEYNOTE-905/EV-303 indication. | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-10 announcement | $RHHBY | F. Hoffmann-La Roche Ltd | Roche announced 52-week MEERKAT/SANDCAT data in uveitic macular edema and FDA acceptance of the vamikibart BLA. The AAO presentation is distinct from the primary 16-week analyses presented in 2025. | HISTORICAL · Disclosed event | Primary source |
| October 10, 2026 | $MRK | Merck & Co., Inc. | One-year BRUNELLO Phase 2b/3 results for remigromig in diabetic macular edema presented at AAO October 10. Both doses met visual-acuity non-inferiority versus ranibizumab; no secondary endpoint showed superiority. Proliferative diabetic retinopathy adverse events and discontinuations were more frequent with remigromig. Not an approval. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-10 | $KOD | Kodiak Sciences Inc. | AAO presentation of GLOW2 Phase 3 results in diabetic retinopathy, October 10 at 4:51 p.m. CT. | HISTORICAL · Outcome unverified | Primary source |
| October 9, 2026 | $VRTX | Vertex Pharmaceuticals Incorporated | Vertex announced NACFC interim ALYFTREK open-label extension data in children aged 2-5 with cystic fibrosis, including recovery of exocrine pancreatic function in some children and pancreatic-enzyme replacement discontinuation. October 9 is the release date; no exact poster date is asserted. Not an approval for this age group. | HISTORICAL · Disclosed event | Primary source |
| October 9, 2026 | $TEVA | Teva Pharmaceutical Industries Ltd. | Teva announced FDA approval of WELTRUZA (olanzapine; TEV-749), a once-monthly subcutaneous long-acting injection for adults with schizophrenia. October 9 is the announcement date; the former Q4 2026 estimated decision is no longer pending. | HISTORICAL · Disclosed event | Primary source Supporting source |
| October 9, 2026 | $MNKD | MannKind Corporation | MannKind disclosed new Furoscix ReadyFlow PK/PD and cross-study analyses ahead of HFSA presentations, supporting comparable diuretic responses to IV furosemide and the on-body infusor. October 9 at 20:00 ET is the news-release date (URL uses UTC October 10). Analyses of an approved product, not a new FDA approval or a pivotal efficacy readout. | HISTORICAL · Disclosed event | Primary source |
| October 9, 2026 | $MLYS | Mineralys Therapeutics, Inc. | October 9 AHA Hypertension release: new Launch-HTN analysis and final Explore-OSA results. Lorundrostat reduced morning blood pressure in Explore-OSA, with no measurable change in apnea-hypopnea indices. Separate from November AHA Transform-HTN extension and October ASN CKD presentations; do not mark those completed. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-09 | $KOD | Kodiak Sciences Inc. | Official AAO DAYBREAK presentation materials are publicly available. The presentation was scheduled for October 9. The September 28 topline remains a separate historical event. | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-09 | $KOD | Kodiak Sciences Inc. | Official presentation materials for the APEX Phase 1b KSI-101 presentation at AAO, scheduled October 9, are publicly available. Separate from the pending PEAK Phase 3 readout in December 2026. | HISTORICAL · Disclosed event | Primary source Supporting source |
| October 9, 2026 | $JNJ | Johnson & Johnson | J&J announced ICONIC-LEAD icotrokinra Week 112 results in plaque psoriasis presented at Fall Clinical: sustained skin clearance and no new safety signals reported. October 9 is the announcement date; this is long-term clinical data, not a new approval. | HISTORICAL · Disclosed event | Primary source |
| October 9, 2026 | $GKOS | Glaukos Corporation | GLK-101-04 Phase 4 iDose TR with cataract surgery met the primary endpoint versus cataract surgery alone in open-angle glaucoma or ocular hypertension. Month-3 mean IOP reduction was 11.1 versus 7.4 mmHg; reported treatment effect 3.6 mmHg (p<0.0001). This is clinical topline, not a new regulatory approval. | HISTORICAL · Disclosed event | Primary source |
| October 9, 2026 | $BMRN | BioMarin Pharmaceutical Inc. | BioMarin disclosed that it recently submitted a VOXZOGO (vosoritide) sNDA for hypochondroplasia. October 9 is the disclosure date, not the actual filing day. No hypochondroplasia FDA action date is supplied; distinct from the existing February 28, 2027 achondroplasia full-approval PDUFA. | HISTORICAL · Disclosed event | Primary source |
| October 9, 2026 | $ALMS | Alumis Inc. | October 9 Fall Clinical release: new ONWARD1/2 and ONWARD3 envudeucitinib analyses of scalp disease, itch and quality of life in plaque psoriasis, including sustained long-term responses. Additional analyses, not a new primary-endpoint topline or approval. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-08 approval; announced October 9 | $RHHBY | Roche | FDA approved Tecentriq plus a fluoropyrimidine and oxaliplatin on October 8, 2026 for adjuvant treatment of stage III dMMR colon cancer in adults and children aged two years or older. Tecentriq Hybreza combination was approved for patients aged 12 or older weighing at least 40 kg. Roche announced the decision October 9. | HISTORICAL · Disclosed event | Primary source Supporting source |
| October 8, 2026 | $PHVS | Pharvaris N.V. | RAPIDe-3 deucrictibant immediate-release on-demand HAE results published in The Lancet, announced October 8. Primary and 11 secondary endpoints met; this is publication of results, not a new topline event. Distinct from CHAPTER-3 XR prophylaxis and the pending April 23, 2027 IR PDUFA. | HISTORICAL · Disclosed event | Primary source |
| October 7, 2026 | $RHHBY | Roche Holding AG | Partner Zealand announced ZUPREME-2 topline in 220 participants with overweight/obesity and type 2 diabetes: primary endpoint met, with up to 9.2% mean weight loss at week 28 versus 2.0% placebo under the efficacy estimand. Original release October 7; October 8 news coverage is not a second event. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-08 | $BBIO | BridgeBio Pharma | Commercial Day in New York City: commercial readiness and launch strategy across three planned launches. Corporate event, not an FDA decision. Time not specified in the source. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-08 announcement | $VIR | Vir Biotechnology, Inc. | Vir announced FDA Fast Track for VIR-5500 in late-line metastatic castration-resistant prostate cancer, co-developed with Astellas. Designation is not approval; the exact designation day was not separately disclosed. | HISTORICAL · Disclosed event | Primary source Trial registry |
| 2026-10-08 announcement | $SRRK | Scholar Rock Holding Corporation | Scholar Rock resubmitted the EMA marketing-authorisation application for apitegromab in spinal muscular atrophy with an alternative fill-finish facility. Resubmission is not EU approval. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-08 announcement | $PCRX | Pacira BioSciences, Inc. | Viatris agreed to acquire Pacira for $36.50 per share in cash, approximately $1.65 billion equity value. The transaction is announced, not closed; tender of a majority of shares and expiration of the applicable regulatory waiting period remain conditions. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-08 announcement | $GKOS | GLAUKOS CORPORATION | Glaukos licensed retinal tri-specific biologic RO-104 and rights to discover up to four additional candidates using RevMod. Reported efficacy is preclinical; financial terms and a human-trial start date were not disclosed. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-08 announcement | $EWTX | Edgewise Therapeutics, Inc. | First patient dosed in Phase 2 EQUINOX-HFpEF, targeting approximately 90 participants with HFpEF and left-ventricular ejection fraction of at least 50%. October 8 is the announcement; actual dosing day is undisclosed. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-08 announcement | $EDIT | Editas Medicine, Inc. | EDIT-401 Phase 1/2 Strive in HeFH received Australian HREC approval and completed the TGA Clinical Trial Notification process. New Zealand review is pending; this is neither FDA clearance nor confirmation of first dosing. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-08 announcement | $CGEM | Cullinan Therapeutics, Inc. | First patient dosed in the planned registrational Phase 2 study of CLN-049 in relapsed/refractory AML. The existing December Phase 1 update remains a separate milestone. | HISTORICAL · Disclosed event | Primary source Trial registry |
| 2026-10-08 announcement | $CATX | Perspective Therapeutics, Inc. | Perspective announced FDA Fast Track for PSV359 in adults with locally advanced unresectable and/or metastatic FAP-positive solitary fibrous tumors. This is a development designation, not marketing approval; actual designation day undisclosed. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-08 announcement | $BMY | BRISTOL MYERS SQUIBB | EXCALIBER-RRMM Phase 3 in 800 patients with relapsed/refractory multiple myeloma: reported PFS hazard ratio 0.49 and median PFS 42 versus 20 months. This is a new PFS analysis, not a new FDA approval; detailed results planned at ASH without an individual presentation day in the release. | HISTORICAL · Disclosed event | Primary source Trial registry |
| 2026-10-08 announcement | $BHVN | Biohaven Ltd. | Biohaven announced an Ono license for IgG degraders in Japan and selected Asian markets, including Phase 3 Graves’ disease candidate BHV-1300. Upfront $80 million at closing plus a conditional $20 million payment within one year; not $100 million guaranteed upfront. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-08 announcement | $ARGX | ARGENX SE | argenx plans to discontinue the Phase 3 UNITY study in Sjögren’s disease following an independent committee futility recommendation. No new safety signal was identified. This does not establish discontinuation of other efgartigimod programs. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-08 announcement | $ARGX | ARGENX SE | Positive Phase 2 celiac-disease topline in 126 participants under a controlled gluten challenge. FB102 met the primary villous-height/crypt-depth endpoint at day 78 (p=0.0176). Phase 3 is planned without a disclosed start day; results do not yet establish approval. | HISTORICAL · Disclosed event | Primary source Trial registry |
| 2026-10-07 announcement | $VTVT | vTv Therapeutics Inc. | vTv announced FDA orphan-drug designation for investigational HPPD in sickle cell disease. Supporting results are preclinical; designation is not approval or proof of efficacy in patients. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-07 announcement | $VALN | Valneva SE | Valneva reported MHRA revocation of the UK IXCHIQ marketing authorisation after benefit-risk reassessment, without a new safety signal. Licences in other jurisdictions remain unchanged according to the issuer; no appeal is planned. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-07 announcement | $RCKT | Rocket Pharmaceuticals, Inc. | Rocket disclosed updated Danon disease findings after its October 6 webinar. The first three patients at the recalibrated dose completed the initial observation period without reported TMA or capillary-leak findings; evidence remains preliminary after serious toxicity at the original dose. The pivotal efficacy population targets 12 males with 12-month co-primary endpoints. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-07 announcement | $PFE | Pfizer Inc. | FDA approved tucatinib with trastuzumab and pertuzumab for maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction therapy. Decision October 7; this is an approval, not an upcoming PDUFA. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-07 announcement | $NVS | Novartis AG | Novartis announced FDA approval of Rhapsido for symptomatic dermographism, expanding beyond chronic spontaneous urticaria. The indication is symptomatic dermographism, not all forms of chronic inducible urticaria. | HISTORICAL · Disclosed event | Primary source |
| October 6–7, 2026 | $GRAL | GRAIL, Inc. | Six EDCC posters include new NHS-Galleri analyses and PATHFINDER 2 detection performance. The listed posters are scheduled October 6–7; the conference continues through October 8. Scheduled presentation is not proof of completion. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-07 announcement | $GKOS | GLAUKOS CORPORATION | Glaukos reported three-year GLK-202-03 keratoconus extension topline after Epioxa: 38 eyes from 35 subjects, with 92% completing the year-three visit. Follow-up after the pivotal study, not a new FDA approval. | HISTORICAL · Disclosed event | Primary source |
| October 2 effective; October 8 announcement | $AGEN | Agenus Inc. | Armenian conditional marketing authorizations for BOT+BAL became effective October 2, announced October 8, for previously treated adult MSS metastatic colorectal cancer without active liver metastases. Each authorization lasts one year and is renewable; these are not FDA approvals. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-07 announcement | $RNXT | RenovoRx | RenovoRx announced first enrollment in University of Vermont investigator-initiated PRISM-TAMP for borderline resectable pancreatic cancer. The approximately 10-patient study evaluates delivery of gemcitabine with RenovoCath. October 7 is the announcement date; the actual enrollment day is undisclosed. ClinicalTrials.gov still lists NOT_YET_RECRUITING at this check; the issuer announcement is distinguished from the registry status. | HISTORICAL · Disclosed event | Primary source Trial registry |
| 2026-10-07 announcement | $MAIA | MAIA Biotechnology, Inc. | MAIA announced completion of enrollment in Part C of THIO-101 Phase 2 in NSCLC. This does not mean the entire trial is completed or new final efficacy results are available. Actual completion day undisclosed. | HISTORICAL · Disclosed event | Primary source Trial registry |
| 2026-10-07 announcement | $LPCN | Lipocine Inc. | Lipocine announced Health Canada approval of oral TLANDO testosterone replacement therapy. October 7 is the release date; the regulator’s decision day is not separately stated. This is Canadian authorization, not a new FDA decision. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-07 announcement | $ICU | SeaStar Medical | SeaStar announced FDA Breakthrough Device Designation for SCD in adult sepsis-related hyperinflammation. This seventh designation is not marketing approval. The announcement gives no exact day for the forthcoming sepsis-subgroup data. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-07 announcement | $BLLN | BillionToOne, Inc. | BillionToOne announced a retrospective liquid-biopsy comparison in advanced solid tumors, published in The Journal of Liquid Biopsy: 169 paired samples from 61 patients. This is diagnostic-monitoring validation, not a randomized therapeutic efficacy trial or FDA approval. | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-07 announcement | $ARWR | Arrowhead Pharmaceuticals | Arrowhead announced FDA STAR pilot entry for the planned plozasiran sHTG supplemental application. This is a review pathway, not approval of the sHTG indication; the entry decision day is not separately disclosed. | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-07 announcement | $ARVN | Arvinas, Inc. | Arvinas reported final Phase 1 Parkinson’s disease data at MDS: 24 patients treated for 28 days, with exploratory oculomotor and CSF biomarker analyses. The study was not designed to establish clinical efficacy. October 7 marks the release. | HISTORICAL · Disclosed event | Primary source Supporting source |
| 2026-10-06 announcement | $QNTM | Quantum BioPharma Ltd. | Quantum announced a study start-up agreement with Thermo Fisher Scientific’s clinical research business for planned Phase 2 Lucid-MS in progressive multiple sclerosis. A CRO agreement is not evidence of first patient dosing; no readout day is given. | HISTORICAL · Disclosed event | Primary source |
| 2026-10-06 announcement | $JUNS | Jupiter Neurosciences, Inc. | Jupiter announced first dosing in investigator-sponsored Phase 2a RESET in Parkinson’s disease, with approximately 30 patients planned. October 6 is the release date; actual dosing day and future public readout date were not specified. | HISTORICAL · Disclosed event | Primary source Supporting source Trial registry |
| September 30 closing; disclosed October 6 | $BYSI | BeyondSpring Inc. | BeyondSpring disclosed October 6 that the sale of BeyondSpring Limited and subsidiaries to Biolin closed September 30. Consideration includes DUBLIN-4 plinabulin data rights outside China, Hong Kong, Macau and Taiwan and trial funding; no public readout date is given. | HISTORICAL · Disclosed event | Primary source |
| October 7 publication | $NRIX | Nurix Therapeutics, Inc. | The Nurix IR release published October 7 at 01:00 ET announced that the first patient had enrolled in Phase 1b/2 NX-5948-203 (NCT07520006), testing bexobrutideg plus venetoclax in CLL/SLL under the Roche collaboration. Its text bears an October 6 dateline. The actual enrollment day was not disclosed; this row marks publication, not a future readout. | HISTORICAL · Enrollment announced | Primary source |
| October 6 announcement | $CRBU | Caribou Biosciences, Inc. | Caribou announced plans to discontinue further development of vispa-cel and CB-011 while evaluating strategic alternatives. The SEC 8-K says the board approved the plan October 2; October 6 is the public announcement date. Formal termination of individual trials is not inferred. | HISTORICAL · Planned discontinuation | Primary source |
| 2026-10-06 | $VKTX | Viking Therapeutics | Initiation of the 195-participant, 33-week Part 2 maintenance study announced October 6. Following weekly subcutaneous induction, it evaluates daily/weekly oral and less-frequent subcutaneous maintenance; distinct from Part 1 and VANQUISH. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-06 | $TLX | Telix Pharmaceuticals Limited | First commercial patients dosed with Pixclara for glioma imaging, announced October 6, marking US commercial availability. FDA approval was earlier; this is not a new approval or trial initiation. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-06 | $SXTP | 60 Degrees Pharmaceuticals, Inc. | October 6 announcement: the October 1 DSMB recommended completing the planned 33-patient hospitalized-babesiosis study. The company elected to stop at 30 enrolled patients for seasonal recruitment reasons. Data remain blinded; no efficacy outcome was released. The scheduled webinar is not assumed completed. | HISTORICAL · Reported outcome | Primary source Trial registry |
| 2026-10-06 | $SCYX | SCYNEXIS, Inc. | Phase 1 results in 25 healthy volunteers reported October 6: safety, tolerability and pharmacokinetic findings; not clinical efficacy evidence. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-06 | $OSTX | OS Therapies Incorporated | Final Phase 2b three-year overall survival in pulmonary metastatic osteosarcoma reported at 72.7%, versus 45.8% in combined historical controls. Nonrandomized comparison, not a concurrent randomized trial. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-06 | $OKYO | OKYO Pharma Limited | OKYO announced the first patients enrolled in pivotal Phase 3 NEPTUNE, evaluating urcosimod for neuropathic corneal pain. Actual first-enrollment date was not disclosed. | HISTORICAL · Reported outcome | Primary source Trial registry |
| 2026-10-06 | $KAPA | Kairos Pharma | Interim prostate-cancer data reported October 6: median PFS 17.7 versus 2 months, p=0.0008. Interim findings from an evolving protocol are not final confirmatory evidence. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-06 | $HSCS | HeartSciences Inc. | FDA 510(k) clearance K260005 for the MyoVista wavECG 12-lead resting electrocardiograph announced October 6. Clearance excludes the AI-ECG algorithm; the company gives no commercialization timeline and does not intend to launch without a cleared algorithm. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-06 | $AVBP | ARRIVENT BIOPHARMA INC | FURVENT in first-line EGFR exon 20 insertion NSCLC missed its primary BICR progression-free survival endpoint. The 240 mg arm had median PFS 11.0 versus 9.5 months, HR 0.75, p=0.0654. Secondary signals do not reverse the primary-endpoint miss; overall survival remains immature. | HISTORICAL · Reported outcome | Primary source Trial registry |
| 2026-10-05 | $ORIC | ORIC Pharmaceuticals, Inc. | Cancer Research UK will fund and sponsor CTA-enabling studies and Phase 1/2 development of ORIC-259, a CIP2A mRNA degrader. ORIC retains an option to reacquire rights after Phase 1/2 data; no trial-start date is announced. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-05 | $KRRO | Korro Bio, Inc. | Korro announced first-cohort dosing of KRRO-121 in healthy volunteers in Phase 1/2 ANCHOR. October 5 is the announcement date; dosing began in September. | HISTORICAL · Reported outcome | Primary source Trial registry |
| 2026-10-05 | $BLFS | BioLife Solutions / Repligen | BioLife shareholder vote on Repligen merger, 09:00 ET / 15:00 Europe/Rome. Closing remains conditional. | HISTORICAL · Outcome unverified | Primary source |
| 2026-10-05 | $VTVT | vTv Therapeutics Inc. | Completion of CATT1 Phase 3 enrollment announced October 5: 166 randomized participants with type 1 diabetes; no new efficacy results. | HISTORICAL · Reported outcome | Primary source Trial registry |
| 2026-10-05 | $STOK | STOKE THERAPEUTICS INC | Completion of FDA meeting on zorevunersen Dravet-syndrome development announced October 5; actual meeting day not disclosed. Company reports alignment on submission approach, not approval. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-05 | $RZLT | Rezolute, Inc. | FDA recommendation to request a Type B pre-BLA meeting announced October 5; no meeting date or approvability conclusion. sunRIZE missed prespecified primary and key secondary endpoints; BLA strategy awaits upLIFT results. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-05 | $RVMD | Revolution Medicines, Inc. | First patients treated in Phase 3 RASolute 309 announced October 5: daraxonrasib plus zoldonrasib in first-line metastatic RAS G12D pancreatic adenocarcinoma. Actual dosing days not disclosed; no approval of this combination. | HISTORICAL · Reported outcome | Company release Trial registry |
| 2026-10-05 | $RADX | Radiopharm Theranostics Limited | Completion of RAD101 end-of-Phase-2 FDA meeting for brain-metastasis imaging announced October 5; actual meeting day unspecified. Formal minutes expected in approximately 30 days, not a fixed deadline or Phase 3 initiation. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-05 | $PRME | Prime Medicine | First patient dosed in Phase 1/2 PM577a for H1069Q-mutated Wilson disease, announced October 5; actual dosing day not disclosed. | HISTORICAL · Reported outcome | Primary source Trial registry |
| 2026-10-05 | $PCVX | VAXCYTE INC | OPUS-1 pivotal adult Phase 3 topline reported October 5: all prespecified primary endpoints met. Individual PCV21 comparisons met the >0.667 criterion for 17/19 serotypes; all 19 met the historical >0.5 threshold. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-05 | $LSTA | Lisata Therapeutics, Inc. | Marea, a Lisata subsidiary, announced first patient dosed in Phase 2 MAR002 for acromegaly October 5; actual dosing day not disclosed. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-05 | $COYA | Coya Therapeutics, Inc. | ALSTARS Phase 2/3 ALS trial reached the target of 120 enrolled participants, announced October 5; additional eligible patients already screening may still enroll. | HISTORICAL · Reported outcome | Primary source Trial registry |
| 2026-10-05 | $BEAT | HeartBeam | FDA Breakthrough Device Designation for at-home assessment of potential heart attacks announced October 5. This designation is not clearance for myocardial-infarction assessment; future pivotal development and regulatory submission are still required. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-05 | $ALVO | ALVOTECH | FDA approval of AVT02/SIMLANDI BLA supplement for a second Reykjavik drug-substance suite announced October 5. Other pending product BLAs remain subject to individual reviews; this is not approval of those applications. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-05 | $ALEC | Alector | Global license with Genentech for preclinical brain-penetrant GCase AL050 announced October 5; agreement dated September 30. $100 million upfront; contingent milestones are not guaranteed. Parkinson’s and other neurodegenerative diseases. | HISTORICAL · Reported outcome | Primary source Supporting source |
| 2026-10-03 | $GMAB | Genmab A/S | Rina-S Phase 2 RAINFOL-01 Part C data in platinum-resistant ovarian cancer reported: 109 patients, 45.9% objective response rate and 12.1-month median response duration. Single-arm data, not randomized comparative evidence. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-03 | $AGEN | Agenus Inc. | IGCS Phase 1b recurrent ovarian-cancer cohort update reported: estimated three-year overall survival 48% in 35 efficacy-evaluable patients. Small nonrandomized cohort; not comparative proof. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-02 | $SRZN | Surrozen | SZN-8141 IND became effective for diabetic macular edema, announced October 2, enabling clinical development; not marketing approval. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-02 | $NVO | Novo Nordisk | Extended denecimig BLA review for hemophilia A with/without inhibitors announced due to manufacturing-facility remediation. No new FDA action timeline and no clinical efficacy/safety deficiencies reported by the company. This is not a CRL. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-02 | $LLY | Eli Lilly and Company | FDA approved pirtobrutinib for previously untreated adult CLL/SLL with no known 17p deletion. | HISTORICAL · Reported outcome | Primary source Trial registry |
| 2026-10-02 | $BIIB | Eisai Inc. | 52-week Phase 2 AMETHYST Part A data in cutaneous lupus erythematosus reported at EADV; separate from the blinded Phase 3 portion. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-01 | $REGN | Regeneron Pharmaceuticals | Regeneron and Sanofi expanded their collaboration to four long-acting immunology antibodies, including Phase 1 REGN20423 for atopic dermatitis. Regeneron is to receive $1 billion upfront and may earn up to $7 billion in milestones; costs and future profits shared equally. Agreement announcement, not confirmation of cash receipt. | HISTORICAL · Reported outcome | Primary source Supporting source |
| 2026-10-01 | $GLUE | Monte Rosa Therapeutics, Inc. | GFORCE-1 Phase 1 data reported October 1. Biomarker reductions do not establish clinical cardiovascular benefit. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-01 | $FHTX | Foghorn Therapeutics | Company announced it will not advance FHD-909 to expansion after Phase 1 and will not advance the selective SMARCA2 degrader collaboration. Development discontinuation, not FDA rejection. | HISTORICAL · Reported outcome | Primary source |
| 2026-10-01 | $CGEM | Cullinan Therapeutics, Inc. | RTOR NDA submission initiated for zipalertinib plus chemotherapy in previously untreated EGFR exon20ins NSCLC. Separate from the second-line monotherapy NDA with February 27, 2027 PDUFA. | HISTORICAL · Reported outcome | Primary source |
| Aug 12, 2026 — announcement | $ALT | Altimmune, Inc. | RESTORE Phase 2 enrollment completed in July 2026; announcement August 12Exact July completion day not disclosed. This row uses the announcement date; the H2 2027 topline is a separate future milestone. | HISTORICAL · Completed event | Primary source |
| Sep 21, 2026 | $NAMS | NewAmsterdam Pharma | Ubeslo / Evlarco: European Commission authorizationEU authorization announced September 21. | HISTORICAL · Completed event | Primary source |
| $GRAL | GRAIL | Galleri — multi-cancer early detection test for adults aged 50 and overOn September 23, the advisory panel voted 7–2 with one abstention that benefits outweigh risks; safety 10–0; effectiveness 6–4, according to GRAIL. The vote is nonbinding. FDA review of the Galleri PMA continues; this is not approval. | HISTORICAL · FAVORABLE ADCOM — FDA PENDING | GRAIL · FDA | |
| Sep 23, 2026 | $ARCT | Arcturus Therapeutics | ARCT-810 Phase 2 interim results and LUNAR 2.0 update releasedResults released September 23 with a webcast. ARCT-2601 integration is a separate future milestone. | HISTORICAL · Completed event | Primary source |
| 2026-09-24 | $MRK | Merck & Co. | Belzutifan plus lenvatinib FDA-approved September 24; former October 4 target resolved. | HISTORICAL · FDA approved | Primary source |
| $MIRM | Mirum Pharmaceuticals | Atebrioz (zilurgisertib)FDA lists approval on September 25, 2026 for reducing new heterotopic ossification in adults and patients aged 12 and older with FOP. Former September 26 PDUFA target resolved; licensed from Incyte. | HISTORICAL · FDA APPROVED | FDA | |
| 2026-09-25 | $MRK | Merck & Co. | Ifinatamab deruxtecan BLA voluntarily withdrawn September 25; former October 10 target superseded. Phase 3 continues. | HISTORICAL · Application withdrawn | Primary source |
| 2026-09-28 | $KOD | Kodiak Sciences | DAYBREAK: Zenkuda and KSI-501 met vision non-inferiority primary endpoints versus aflibercept; sponsor topline September 28. Zenkuda 54% at 24-week dosing. Not FDA approval. | HISTORICAL · Results published | Primary source |
| Sep 24, 2026 | $KYTX | Kyverna Therapeutics, Inc. | Phase 2 longer-term miv-cel follow-up in generalized myasthenia gravis released September 24, 2026. The former Q3 window is resolved. | HISTORICAL · Results released | Primary source |
| Sep 24, 2026 | $KYTX | Kyverna Therapeutics, Inc. | One-year miv-cel topline in stiff person syndrome released September 24, 2026. The former Q3 window is resolved. | HISTORICAL · Results released | Primary source |
| Sep 24, 2026 | $ACAD | Acadia Pharmaceuticals Inc. | Phase 2 remlifanserin topline released September 24, 2026. Primary endpoint missed statistical significance (p=0.0603); Phase 3 continuation planned with protocol amendments. | HISTORICAL · Results released | Primary source |
| 2026-09-28 | $ACET | Adicet Bio, Inc. | Prula-cel Phase 1 clinical data released in SLE/LN. | HISTORICAL — Results released | Primary source |
| 2026-09-28 | $MIRM | Mirum Pharmaceuticals | AZURE-1 Phase 3 brelovitug topline released; primary endpoint met. | HISTORICAL — Results released | Primary source |
| 2026-09-29 | $IVVD | Invivyd, Inc. | LIBERTY Phase 3 VYD2311 safety/tolerability topline released; distinct DECLARATION study remains pending. | HISTORICAL — Results released | Primary source |
| Q3 2026 | $IVVD | Invivyd, Inc. | Prior combined LIBERTY/DECLARATION forecast superseded by separate company updates on 29 September. | HISTORICAL — Superseded forecast | Primary source |
| 2026-09-28 | $IVA | Inventiva S.A. | First-half 2026 financial results published; conference call announced for 08:00 ET. | HISTORICAL — Results released | Primary source |
| 2026-09-28 | $IMMP | Immutep Limited | Announced ADS-ratio change. | HISTORICAL — Execution unverified | Primary source |
| 2026-09-28 | $SABS | SAB Biotherapeutics | SAB-142 Phase 1 presentation scheduled at EASD. | HISTORICAL — Occurrence unverified | Primary source |
| 2026-09-29 | $KYTX | Kyverna Therapeutics | KYSA-6 Phase 2 follow-up presentation scheduled at AANEM. | HISTORICAL — Occurrence unverified | Primary source |
| $SRPT | Sarepta Therapeutics | WMS Duchenne data presentationsScheduled scientific presentation, not an automatic pivotal readout. Stock Hub | HISTORICAL — Occurrence unverified | Primary source | |
| Sep 30, 2026 | $INCY | Incyte Corporation | STOP-HS Phase 3 povorcitinib posters at EADV 2026. Incyte lists two povorcitinib STOP-HS1/STOP-HS2 Phase 3 poster abstracts for the EADV 2026 session on 30 September 2026 at 07:00 CEST, covering acne and high-disease-burden analyses. This is a congress presentation of additional analyses, not a new topline readout | HISTORICAL — Occurrence unverified | Primary source |
| Sep 30, 2026 | $INCY | Incyte Corporation | TRuE-AD4 ruxolitinib cream poster at EADV 2026. Incyte lists the TRuE-AD4 poster on ruxolitinib cream in moderate atopic dermatitis for the EADV 2026 session on 30 September 2026 at 07:00 CEST. This is a congress presentation, not a new pivotal topline readout | HISTORICAL — Occurrence unverified | Primary source |
| Sep 30, 2026 | $SABS | SAB Biotherapeutics, Inc. | three SAB-142 Phase 1 presentations at EASD 2026 | HISTORICAL — Occurrence unverified | Primary source |
| Oct 1, 2026 · 16:30 CEST | $NKTR | Nektar Therapeutics | REZOLVE-AA Phase 2b 52-week rezpegaldesleukin data oral presentation at EADVPresentation 16:30-16:40 CEST, Hall N, abstract AS-1872; conference discussion of previously reported data. | HISTORICAL — Results released | Primary source |
| Oct 1, 2026 · 10:25 CEST | $NKTR | Nektar Therapeutics | REZOLVE-AD Phase 2b maintenance rezpegaldesleukin data oral presentation at EADVPresentation 10:25-10:35 CEST, Hall N, abstract AS-1732; distinct from initial topline. | HISTORICAL — Results released | Primary source |
| Oct 1, 2026 · session 16:30–18:00 CEST | $ARTV | Artiva Biotherapeutics, Inc. | AlloNK (AB-101) plus rituximab Sjogren disease clinical data presentation at ISSjDConfirmed presentation day. Session 16:30-18:00 CEST; individual talk time unspecified. Data from 11 patients; not a Phase 3 RA readout. | HISTORICAL — Results released; oral session unverified | Primary source |
| Oct 1, 2026 · 16:30 CEST | $EVMN | Evommune, Inc. | EVO301 Phase 2a atopic dermatitis late-breaking data presentation at EADV16:30-16:45 CEST, Hall A. Topline was already released in February; this is a conference presentation. | HISTORICAL — Occurrence unverified | Primary source |
| Oct 2, 2026 | $SANA | Sana Biotechnology, Inc. | UP421 clinical-data symposium at EASD 2026Presentation day confirmed; no presentation time inferred. | HISTORICAL — Occurrence unverified | Primary source |
| $TRDA | Entrada Therapeutics | ENTR-601-44 pharmacokinetic / pharmacodynamic translation presentation at WMSScientific presentation; not assumed to be a new patient efficacy readout. Stock Hub | HISTORICAL — Occurrence unverified | Primary source | |
| Sep 27–30, 2026 (conference) | $BIAF | bioAffinity Technologies, Inc. | CyPath Lung posters at NAVREF 2026The individual poster presentation days have not been announced. | HISTORICAL — Occurrence unverified | Primary source |
| 2026-09-29 | $QURE | uniQure N.V. | uniQure released the four-year (48-month) Phase I/II data for AMT-130 (ifezuntirgene inilparvovec) in Huntington's disease on September 29, 2026. In 12 high-dose patients at 48 months, cUHDRS showed 44% slowing of disease progression versus an updated external control (not statistically significant, p=0.144) and TFC showed 61% slowing (nominal p=0.008); an updated 36-month analysis of 15 high-dose patients showed 80% slowing on cUHDRS (nominal p=0.005) and 67% on TFC (nominal p=0.011). | HISTORICAL · Disclosed event | SEC filing SEC filing Supporting source |
| Q3 2026 | $CRMD | CorMedix Therapeutics | REZZAYO prophylaxis sNDA submissionCompany-guided submission window. | HISTORICAL — Estimate expired; outcome unverified | Primary source |
| 2026-09-30 | $MLTX | MoonLake Immunotherapeutics | MoonLake submitted a BLA to the FDA on September 30, 2026 for sonelokimab in moderate-to-severe hidradenitis suppurativa in adults and pediatric patients 12 years of age and older. The company expects to learn whether the BLA is accepted for review within about 60 days of submission, and to receive the planned review timeline within about 74 days. | HISTORICAL · Disclosed event | SEC filing Supporting source Supporting source |
| Sep 30, 2026 | $BMY | Bristol Myers Squibb | CAMZYOS (mavacamten): FDA approved pediatric oHCM expansion for patients weighing at least 30 kg. | HISTORICAL — FDA approved | Primary source |
| September 29 to October 3, 2026 | $CAPR | Capricor Therapeutics, Inc. | Deramiocel HOPE-3 and HOPE-3 OLE presentations at WMS 2026HOPE-3 oral presentation is confirmed October 3. Late-breaking HOPE-3 OLE poster day is not specified by this release. Conference in Hiroshima, Japan. | Conference range | Primary source |
The Tracker shows a curated feed of upcoming catalysts and open windows; the Calendar also retains history. The AI Lookup searches the web for current information on the complete ticker universe, including tickers with only historical events. ClinicalTrials.gov data-collection dates are not results-publication dates. Windows and deadlines can change. Educational information only; not financial advice.
The free Biotech Catalyst Calendar combines an embedded archive with a sourced selection of regulatory deadlines, clinical readouts, congress presentations and company milestones. Exact dates and estimated windows are labeled separately; completed events remain in history.
The page also includes a glossary covering key FDA, clinical trial, and catalyst terminology, including regulatory designations, trial progress stages, and common clinical metrics. All data is sourced from public information and may contain errors or estimated dates; users are advised to verify with official sources before making any decisions.
Biotech Catalyst Lookup
Type a ticker to get an AI-generated snapshot of the next catalyst (PDUFA, clinical data, regulatory events) with a link to the primary source.
Automatically generated AI snapshot
Enter a ticker to receive a snapshot generated by artificial intelligence using web sources. Responses are not individually checked by a person before they are displayed.
Dates, events and sources may be incomplete, incorrect or out of date. Check the information against official company releases, SEC filings, FDA documents or ClinicalTrials.gov. Estimated dates are not firm deadlines.
For information and education only. Not investment advice or a recommendation to buy or sell securities.
Read the full disclaimerRecently viewed catalysts
DRTSClinical
Alpha Tau Medical Ltd. (Nasdaq: DRTS)
Presentation of new REGAIN trial data (safety interim analysis) at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO) 2026, Philadelphia
2026-11-13
CRBPClinical
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP)
Late-breaking presentation of CANYON-1 Phase 1b efficacy, safety and tolerability data at ObesityWeek 2026
2026-11-15
VKTXClinical
Viking Therapeutics, Inc.
VANQUISH-1 and VANQUISH-2 Phase 3 topline results for subcutaneous VK2735 in obesity (not yet announced)
2027
SRPTPDUFA
Sarepta Therapeutics, Inc.
FDA target action date for supplemental applications seeking traditional approval of AMONDYS 45 (casimersen) and VYONDYS 53 (golodirsen)
2027-02-28
IBRXData readout
ImmunityBio, Inc.
Topline results from QUILT-2.005 Cohort A, a registrational trial of ANKTIVA plus BCG versus BCG alone in BCG-naive non-muscle-invasive bladder cancer
November 2026
SENSCatalyst
Senseonics Holdings, Inc.
Commercial launch of the integrated Eversense 365 and Beta Bionics iLet Bionic Pancreas system
Q4 2026
NKTRClinical
Nektar Therapeutics
Initiation of the Phase 3 ZENITH AA study of rezpegaldesleukin in severe-to-very-severe alopecia areata
early 2027
ROIVRegulatory
Roivant Sciences Ltd. (Nasdaq: ROIV)
Planned supplemental New Drug Application (sNDA) submission for brepocitinib in non-infectious uveitis (NIU)
first half of calendar year 2027
BHVNPDUFA
Biohaven Ltd. (NYSE: BHVN)
FDA action on the resubmitted new drug application for Vyglxia (troriluzole) in spinocerebellar ataxia (SCA), with a user fee goal date in the first quarter of 2027; an advisory committee meeting is also planned with date to be announced
first quarter of 2027
ABOSClinical
Acumen Pharmaceuticals, Inc. (ABOS)
Topline results from the Phase 2 ALTITUDE-AD trial of intravenous sabirnetug in early Alzheimer's disease
late 2026
IMRXClinical
Immuneering Corporation (IMRX)
Topline data from the pivotal Phase 3 MAPKeeper 301 trial of atebimetinib plus mGnP in first-line metastatic pancreatic cancer
mid-2028
TGTXClinical
TG Therapeutics, Inc.
Topline Phase 3 data for subcutaneous BRIUMVI (ublituximab-xiiy) in relapsing multiple sclerosis
year-end 2026 or Q1 2027 (company window; no exact day announced)
Catalyst Calendar Glossary
Quick definitions for FDA, clinical-trial, and “catalyst” terms used in the calendar & trackers.
1) FDA / Regulatory
| Term | Meaning |
|---|---|
| PDUFA date | FDA target action date for an NDA/BLA decision (often disclosed via filings/press releases). |
| Priority Review | FDA review goal generally 6 months; the clock depends on the application type. It does not guarantee approval or a decision on a fixed date. |
| Standard Review | FDA review goal generally 10 months; clock start and pathway depend on the application. |
| AdCom | Advisory committee: reviews evidence and may vote; a meeting does not imply approval and its advice is not binding on FDA. |
| NDA / BLA | Applications to approve a drug (NDA) or a biologic (BLA). |
| sNDA / sBLA | Supplemental application (label expansion, new population, new formulation, etc.). |
| Filing acceptance | FDA accepts the application as sufficiently complete to start review (often when PDUFA is set). |
| RTF (Refuse-to-File) | FDA declines to accept an application for review (formal/technical deficiencies). |
| CRL (Complete Response Letter) | FDA does not approve at that time and requests additional info/changes before resubmission. |
| Resubmission (Class 1 / Class 2) | Re-file after CRL; Class 1 = minor changes (often shorter), Class 2 = major (often longer). |
| PDUFA delay/extension | FDA pushes the action date (more time needed for review, inspections, analyses, etc.). |
2) FDA Meetings
| Term | Meaning |
|---|---|
| Type A | Urgent/critical meeting (clinical hold, disputes, time-sensitive issues). |
| Type B | Standard “milestone” meeting (End-of-Phase, pre-NDA/BLA, etc.). |
| Type C | Other focused meeting on specific topics; can still be strategically important. |
| EOP (End-of-Phase) | Aligns requirements to move forward (next phase / registrational plan / filing path). |
| SPA | Special Protocol Assessment: FDA agrees in advance on design/endpoint of a key trial (not a guarantee). |
3) Trial Progress vs Data Release
| Term | Meaning | Data released? |
|---|---|---|
| Enrollment Initiation | First sites/patients start enrolling. | NO |
| Enrollment Complete | Enrollment finished (no more new patients). | NO |
| Trial Completed | Final protocol-defined data collection completed. Primary completion concerns primary outcomes; study completion includes secondary outcomes and adverse events. Neither means results have been published. | NO |
| Database Lock | Dataset is finalized for analysis (internal milestone). | NO |
| Interim Data | Results from an interim analysis, which may remain internal. They count as released data only when publicly disclosed. | IF DISCLOSED |
| Topline Data | High-level results release (often via PR/filing). | YES |
| Data Released / Readout | Results publicly disclosed; internal analysis alone does not constitute a public readout. | YES |
| Full Results / Full Dataset | Detailed results published or presented; does not necessarily mean access to the full raw dataset. | YES |
| Conference Presentation | Abstract, poster or oral presentation. A scheduled slot alone does not establish that new results have been released. | IF DISCLOSED |
| Publication | Peer-reviewed paper / full write-up. | YES |
Key rule: “Trial Completed” ≠ “Data Released”. Completion is an operational milestone; data can come weeks/months later.
4) Common Clinical Metrics
| Term | Meaning |
|---|---|
| OS | Overall Survival. |
| PFS | Progression-Free Survival. |
| ORR | Objective Response Rate (CR + PR). |
| CR / PR | Complete / Partial Response. |
| SD / PD | Stable Disease / Progressive Disease. |
| DOR | Duration of Response. |
| AE / SAE | Adverse event / serious adverse event under regulatory criteria, such as death, life-threatening events or hospitalization. Seriousness differs from severity of intensity; causation is not automatic. |
| PK / PD | Pharmacokinetics / Pharmacodynamics. |
| Biomarker | Biological marker used for selection/response/target engagement. |
5) “Accelerators” / Designations
| Term | Meaning |
|---|---|
| ODD | Orphan Drug Designation (rare-disease incentives). |
| FTD | Fast Track Designation (more frequent interactions; potential rolling submission). |
| BTD | Breakthrough Therapy Designation: preliminary clinical evidence of potential substantial improvement on clinically significant endpoints over available therapies for a serious condition. It is not approval. |
| RMAT | Designation for eligible regenerative therapies, including certain cell, tissue and gene therapies, with preliminary clinical evidence of potential to address unmet needs in serious conditions. It is not approval. |
| RPDD / PRV | RPDD is a rare pediatric disease designation. A PRV is a separate voucher that may be awarded with a qualifying approval and transferred or used to request priority review of another application. Designation guarantees neither a voucher nor approval. |
6) Calendar Fields (how to read them)
| Field | Meaning |
|---|---|
| Stage | Program phase (Preclinical, Phase 1/2/3, NDA/BLA Filing, PDUFA, etc.). |
| Status | Operational status (Ongoing, Trial Completed, Data Released, Clinical Hold, etc.). |
| Next catalyst | Next expected milestone (Topline, Interim, Conference, Submission, Regulatory Decision). |
| Catalyst date | Date or time window (exact / month / quarter / half / year / range). |
Glossary sources: FDA BTD · FDA RMAT · FDA RPDD/PRV · FDA SAE · ClinicalTrials.gov
Related research
- Biotech Stocks Hub — company-level biotech research index.
- what a PDUFA date means, what a Complete Response Letter means and how to read a biotech cash runway.
Methodology
Stock Hub follow-up, September 27, 2026: 18 missing events added for CGEM, TRDA, SRPT, ORKA and PRAX, checked against sponsor or SEC disclosures. Existing relutrigine and EVERLAST entries were preserved. Scheduled scientific presentations are distinguished from new efficacy readouts; company windows remain estimates. This targeted addition does not re-verify unrelated archive entries.
Sources: FDA documents, SEC filings, sponsor releases and ClinicalTrials.gov. The September 27, 2026 review integrates 49 new or recovered future milestones, updates ACET, ACIU, XENE and CAPR, and separates completed events into history. Other entries retain earlier September 19–26 checks; this update does not re-certify every archive entry. The embedded calendar may include historical events and estimated windows. Registry dates concern data collection, not necessarily public readouts. Stated times include their timezone; EDT is New York daylight time and CEST is daylight time in Italy.
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Join @merlintraderpub_com on TelegramImportant Disclaimer
The dates and events shown in this calendar are collected from publicly available sources and company communications, but may change at any time and may contain errors, inaccuracies, delays or omissions. Some dates are estimated, some timelines may be revised, and certain catalysts may be postponed, cancelled or updated without notice. Always verify with official press releases, SEC filings and primary company sources before making any trading or investment decision.
This content is for educational and informational purposes only. It is not investment advice and not a recommendation to buy or sell any security. Do your own research and consult a licensed advisor. Full disclaimer: merlintrader.com/disclaimer.
