Biotech Catalyst Calendar 2026: FDA and PDUFA Calendar
FDA decisions, PDUFA dates, advisory committees and clinical-trial readouts for U.S.-listed biotech stocks.
Calendar last reviewed: August 29, 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 U.S. biotech and healthcare companies.
Each entry is designed to show the expected timing, event type, company context and available source trail. Confirmed FDA dates are listed in the table below, each with its primary source, and the full schedule is available in the embedded calendar.
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.
Confirmed FDA catalyst dates — August to December 2026
Every entry below has a date confirmed by a primary source: a company press release, an SEC filing or an FDA notice. Estimated windows such as Q3, second half or mid-year are deliberately excluded, and so are the estimated trial completion dates taken from ClinicalTrials.gov. Those live in the Catalyst Total Tracker instead.
August 2026
| Date | Ticker | Company | Event | Type | Source |
|---|---|---|---|---|---|
| $RARE | Ultragenyx Pharmaceutical | GENGLYCOS (pariglasgene brecaparvovec-opnr, formerly DTX401), AAV8 gene therapy — glycogen storage disease type IaAccelerated approval granted on 19 August 2026, four days ahead of the 23 August goal date, for adult and pediatric patients aged 8 years and older with glycogen storage disease type Ia. | Approved | Source | |
| $REGN | Regeneron Pharmaceuticals | Pasatru (garetosmab-grts), anti-activin A monoclonal antibody — fibrodysplasia ossificans progressiva in adultsFirst and only FDA-approved treatment for FOP, cutting new heterotopic ossification lesions and clinician-assessed flare-ups. The company had disclosed an August 2026 target action date, without a specific day. | Approved | Source | |
| $JNJ | Johnson & Johnson | Imaavy (nipocalimab-aahu), FcRn blocker — warm autoimmune hemolytic anemia, patients aged 12 and olderApproved on 24 August 2026 following priority review: it is the first therapy authorised specifically for this disease and the second Imaavy indication after generalised myasthenia gravis. | Approved | Source | |
| $JAZZ | Jazz Pharmaceuticals | Ziihera (zanidatamab-hrii) — first-line HER2-positive advanced or metastatic gastroesophageal adenocarcinomaapproved on 25 August 2026: Ziihera with Tevimbra and chemotherapy in IHC 3+ and IHC 2+/ISH+ disease, and with chemotherapy alone in IHC 3+ disease | Approved | Source | |
| $ZYME | Zymeworks | Ziihera (zanidatamab-hrii), commercialised by Jazz — first-line HER2-positive gastroesophageal adenocarcinoma, HERIZON-GEA-01 trialapproved on 25 August 2026: Ziihera with Tevimbra and chemotherapy in IHC 3+ and IHC 2+/ISH+ disease, and with chemotherapy alone in IHC 3+ disease; Zymeworks earned the $250 million milestone | Approved | Source | |
| $RVMD | Revolution Medicines | Rasonque (daraxonrasib), oral RAS(ON) multi-selective inhibitor — metastatic pancreatic adenocarcinoma after at least one prior systemic therapy, or in patients who are not candidates for multiagent therapyFirst broad RAS-targeted medicine approved in metastatic pancreatic cancer. One 300 mg tablet daily, with no companion diagnostic required. Thirty-five days passed between NDA acceptance on 22 July 2026 and approval; no PDUFA date had been made public. | Approved | Source | |
| $GILD | Gilead Sciences | Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), once-daily single tablet — HIV in virologically suppressed adultsapproved on 27 August 2026, on the goal date, based on the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials; it is the first single tablet regimen for virologically suppressed people on complex regimens | Approved | Source | |
| $ROIV | Roivant Sciences | Lisraya (brepocitinib) 30 mg, oral TYK2/JAK1 inhibitor — dermatomyositis in adultsFirst oral drug approved for adult dermatomyositis. The application is held by Priovant Therapeutics, a Roivant company. The target action date had been disclosed only as the third quarter of 2026. | Approved | Source | |
| $PTGX | Protagonist Therapeutics | Mimrylo (rusfertide), weekly subcutaneous hepcidin mimetic — erythrocytosis in adults with polycythemia veraFirst hepcidin mimetic approved by the FDA. The approval belongs to Takeda, which holds worldwide rights; Protagonist discovered the molecule and led development through Phase 3, with a US co-commercialisation option. The target action date had been disclosed only as the third quarter of 2026. | Approved | Source |
September 2026
| Date | Ticker | Company | Event | Type | Source |
|---|---|---|---|---|---|
| $IONS | Ionis Pharmaceuticals | Zanvastro (zilganersen), antisense oligonucleotide — Alexander disease, pediatric and adult patientsApproved on 3 September 2026, nineteen days ahead of the 22 September goal date. It is the first drug authorised for Alexander disease and is given intrathecally every three months. | Approved | Source | |
| $AZN | AstraZeneca | Etcamah (camizestrant), selective estrogen receptor degrader, in combination with a CDK4/6 inhibitor — HR-positive, HER2-negative locally advanced or metastatic breast cancer with an ESR1 mutation emerging during therapyAccelerated approval granted on 4 September 2026 on SERENA-6 data, after the Oncologic Drugs Advisory Committee failed to reach a majority in favour in April 2026 and the FDA extended the decision date on 27 May 2026. The Guardant360 CDx assay was approved alongside it as a companion diagnostic. | Approved | Source | |
| $TLX | Telix Pharmaceuticals | Pixclara (floretyrosine F 18), PET agent — glioma imaging, to distinguish recurrence or progression from treatment-related changeNDA resubmitted and re-accepted by the FDA on 10 April 2026 | PDUFA | Source | |
| $RARE | Ultragenyx Pharmaceutical | UX111 (rebisufligene etisparvovec), gene therapy — Sanfilippo syndrome type ABLA resubmitted after the July 2025 CRL | PDUFA | Source | |
| $MRK | Merck & Co. | Winrevair (sotatercept-csrk) — label update in pulmonary arterial hypertension, HYPERION trial | PDUFA (sBLA) | Source | |
| $GRAL | GRAIL | Galleri, multi-cancer diagnostic test — multi-cancer early detection in adults aged 50 and overMolecular and Clinical Genetics Panel, on a diagnostic device PMA | AdCom | Source | |
| $MIRM | Mirum Pharmaceuticals | zilurgisertib, oral ALK2 inhibitor — fibrodysplasia ossificans progressiva, aged 12 and overmolecule licensed from Incyte, NDA held by Mirum | PDUFA | Source | |
| $BFRI | Biofrontera | Ameluz (aminolevulinic acid gel), with BF-RhodoLED lamps — photodynamic therapy of superficial basal cell carcinoma | PDUFA (sNDA) | Source | |
| $BMY | Bristol Myers Squibb | Camzyos (mavacamten) — extension to adolescents with symptomatic obstructive hypertrophic cardiomyopathy | PDUFA (sNDA) | Source |
October 2026
| Date | Ticker | Company | Event | Type | Source |
|---|---|---|---|---|---|
| $MRK | Merck & Co. | Welireg (belzutifan) with Lenvima (lenvatinib) — advanced clear cell renal cell carcinoma, after a PD-1 or PD-L1 inhibitor | PDUFA (sNDA) | Source | |
| $RHHBY | Roche | Tecentriq (atezolizumab) and Tecentriq Hybreza in combination with chemotherapy, adjuvant use — stage III colon cancer with deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) statusPriority review granted on data from the phase III ATOMIC study in 712 patients; Roche states the FDA is expected to decide by 9 October 2026. | PDUFA (sBLA) | Source | |
| $MRK | Merck & Co. | ifinatamab deruxtecan (I-DXd) — extensive-stage small cell lung cancer, after platinum-based chemotherapyco-developed with Daiichi Sankyo | PDUFA | Source | |
| $RHHBY | Roche | Enspryng (satralizumab), interleukin-6 receptor inhibitor — moderate-to-severe thyroid eye diseasePriority review on the phase III SatraGO-1 and SatraGO-2 studies; if approved it would be the first at-home subcutaneous treatment option for this indication. | PDUFA (sBLA) | Source | |
| $IRD | Opus Genetics | phentolamine ophthalmic solution 0.75% — presbyopia | PDUFA (sNDA) | Source | |
| $VTRS | Viatris | MR-141 (phentolamine ophthalmic solution 0.75%) — presbyopia | PDUFA (sNDA) | Source | |
| $PHAR | Pharming Group | Joenja (leniolisib) — activated PI3K-delta syndrome, paediatric extension from 4 to 11 yearsresubmission accepted on 4 June 2026 after the 30 January 2026 CRL | PDUFA (sNDA) | Source | |
| $IONS | Ionis Pharmaceuticals | bepirovirsen, developed with GSK — chronic hepatitis B | PDUFA | Source | |
| $INO | Inovio Pharmaceuticals | INO-3107, DNA immunotherapy — recurrent respiratory papillomatosis in adults | PDUFA (BLA) | Source |
November 2026
| Date | Ticker | Company | Event | Type | Source |
|---|---|---|---|---|---|
| $AGIO | Agios Pharmaceuticals | Pyrukynd (mitapivat) — sickle cell disease, accelerated approval pathway | PDUFA (sNDA) | Source | |
| $BTAI | BioXcel Therapeutics | Igalmi (dexmedetomidine, sublingual film) — acute agitation in bipolar disorder or schizophrenia, at-home use | PDUFA (sNDA) | Source | |
| $CYTK | Cytokinetics | aficamten — obstructive hypertrophic cardiomyopathy, extension based on the MAPLE-HCM trial | PDUFA (sNDA) | Source | |
| $SMMT | Summit Therapeutics | ivonescimab (SMT112) — EGFR-mutated non-squamous NSCLC, after TKI, in combination with chemotherapy | PDUFA | Source | |
| $CAPR | Capricor Therapeutics | deramiocel (CAP-1002), cell therapy — Duchenne muscular dystrophy cardiomyopathyClass 2 resubmission after the July 2025 CRL; on 24 August 2026 the FDA extended the target action date from 22 August to 22 November 2026, classifying the amendment containing 24-month HOPE-3 data as a major amendment | PDUFA | Source | |
| $SVRA | Savara | Molbreevi (molgramostim), inhalation solution — autoimmune pulmonary alveolar proteinosisdate extended by three months for a major amendment | PDUFA | Source | |
| $SNY | Sanofi | venglustat, oral glucosylceramide synthase inhibitor — Gaucher disease type 3, neurological manifestations | PDUFA | Source | |
| $BBIO | BridgeBio Pharma | BBP-418 — limb-girdle muscular dystrophy LGMD2I/R9 | PDUFA | Source | |
| $GSK | GSK | neladalkib (NVL-655) — advanced ALK-positive NSCLC, previously treated with TKIformerly a Nuvalent asset, acquired by GSK on 15 July 2026 | PDUFA | Source | |
| $PYPD | PolyPid | D-PLEX100, local prolonged-release doxycycline depot — prevention of surgical site infections in colorectal surgery | PDUFA | Source | |
| $COGT | Cogent Biosciences | bezuclastinib, with sunitinib — gastrointestinal stromal tumours previously treated with imatinib | PDUFA | Source | |
| $RHHBY | Roche | giredestrant — adjuvant treatment of ER-positive, HER2-negative early breast cancer, lidERA trial | PDUFA | Source | |
| $VRTX | Vertex Pharmaceuticals | povetacicept, dual BAFF and APRIL inhibitor — IgA nephropathy, accelerated approval pathway | PDUFA | Source |
December 2026
| Date | Ticker | Company | Event | Type | Source |
|---|---|---|---|---|---|
| $EXEL | Exelixis | zanzalintinib, with atezolizumab — third-line or later metastatic colorectal cancer, STELLAR-303 trial | PDUFA | Source | |
| $VNDA | Vanda Pharmaceuticals | imsidolimab, IL-36R antagonist — generalized pustular psoriasismolecule originated by AnaptysBio, BLA held by Vanda | PDUFA | Source | |
| $CORT | Corcept Therapeutics | relacorilant, selective glucocorticoid receptor antagonist — Cushing's syndromeNDA resubmitted on 17 June 2026 after a CRL on this indication | PDUFA | Source | |
| $RHHBY | Roche | giredestrant, with everolimus — ER-positive, ESR1-mutated advanced breast cancer | PDUFA | Source | |
| $MLYS | Mineralys Therapeutics | lorundrostat — hypertension in adults, in combination with other antihypertensives | PDUFA | Source | |
| $GILD | Gilead Sciences | anito-cel (anitocabtagene autoleucel), anti-BCMA CAR-T — relapsed or refractory multiple myeloma, fourth lineBLA filed by Arcellx, acquired by Gilead on 28 April 2026 | PDUFA | Source | |
| $PRAX | Praxis Precision Medicines | relutrigine — SCN2A and SCN8A developmental and epileptic encephalopathiesdate extended from 27 September 2026 for a major amendment | PDUFA | Source | |
| $VTRS | Viatris | fast-acting meloxicam — moderate to severe acute pain, non-opioid analgesic | PDUFA | Source | |
| $COGT | Cogent Biosciences | bezuclastinib monotherapy — non-advanced systemic mastocytosis | PDUFA | Source |
Since the previous update ten decisions have come in and remain in the table with their outcome: $JNJ's Imaavy (nipocalimab-aahu) in warm autoimmune hemolytic anemia, approved on 24 August 2026; $RARE's GENGLYCOS (pariglasgene brecaparvovec-opnr) in glycogen storage disease type Ia, approved on 19 August 2026, four days ahead of the goal date; $REGN's Pasatru (garetosmab-grts) in fibrodysplasia ossificans progressiva, approved on 19 August 2026; Ziihera (zanidatamab-hrii) from $JAZZ and $ZYME in first-line HER2-positive gastroesophageal adenocarcinoma, approved on 25 August 2026; $RVMD's Rasonque (daraxonrasib) in metastatic pancreatic adenocarcinoma, approved on 26 August 2026; $GILD's Bixlenvo in HIV, approved on 27 August 2026 on the goal date; $ROIV's Lisraya (brepocitinib) in adult dermatomyositis, approved on 27 August 2026; Mimrylo (rusfertide) in polycythemia vera, approved on 28 August 2026 to Takeda, which holds worldwide rights to the molecule discovered by $PTGX; $IONS' Zanvastro (zilganersen) in Alexander disease, approved on 3 September 2026, nineteen days ahead of the 22 September goal date and the first drug authorised for the disease; and $AZN's Etcamah (camizestrant) in ESR1-mutated breast cancer, granted accelerated approval on 4 September 2026. The PDUFA date for $CAPR's deramiocel was instead extended from 22 August to 22 November 2026: the FDA classified the amendment containing 24-month HOPE-3 data as a major amendment. Entries removed earlier stay out of the table because the FDA acted before the period it covers: iberdomide (ZENBEXUS, $BMY) approved on 13 August 2026; Padcev with Keytruda or Keytruda Qlex in muscle-invasive bladder cancer ($MRK and $PFE) approved on 10 July 2026; the Leqembi Iqlik subcutaneous initiation dose ($BIIB) approved on 13 July 2026; and zidesamtinib, approved as JIDEYTRO ($GSK), on 22 July 2026. Three fourth-quarter decisions also stay out because no primary source gives a day: $REGN's cemdisiran in generalised myasthenia gravis, guided only to November 2026; $BAYRY's sevabertinib in first-line HER2-mutated NSCLC; and $NVO's Mim8 (denecimig) in haemophilia A. FDA target dates can move. A PDUFA date is the date by which the agency aims to act, not a promise that it will, and a review can be extended by three months if the sponsor files a major amendment. Check the linked source before acting on any entry. Educational content only, not investment advice.
A free Biotech Catalyst Calendar is available as an embedded calendar and as a table of confirmed FDA dates, designed to help traders track upcoming price-moving events such as clinical trial readouts, FDA decisions, and regulatory milestones. Every date in the table is confirmed by a primary source and linked to it.
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
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Disclaimer. This content is for educational and informational purposes only. It is not investment advice and not a recommendation to buy or sell any security, in line with SEC (USA) guidance. Data is generated by AI from web sources and may contain errors or be out of date — always verify against the linked primary source. Do your own research and consult a licensed advisor. Full disclaimer: merlintrader.com/disclaimer.
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 | Shorter FDA review timeline (commonly ~6 months). |
| Standard Review | Standard FDA review timeline (commonly ~10 months). |
| AdCom | Advisory Committee meeting with public discussion and a vote (FDA is not bound by it). |
| 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 | Study finished operationally (often LPLV / last patient last visit). | NO |
| Database Lock | Dataset is finalized for analysis (internal milestone). | NO |
| Interim Data | Partial analysis/results at a predefined checkpoint. | YES (partial) |
| Topline Data | High-level results release (often via PR/filing). | YES |
| Data Released / Readout | Explicit statement that results are out / analyzed. | YES |
| Full Results / Full Dataset | Detailed data (often conference/paper). | YES |
| Conference Presentation | Results presented at a meeting (abstract/poster/oral). | USUALLY |
| 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. |
| 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 (strong early clinical evidence; closer FDA guidance). |
| RMAT | Regenerative Medicine Advanced Therapy designation (cell/gene/regenerative). |
| RPDD / PRV | Priority Review Voucher (can shorten review or be monetized). |
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). |
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
Dates and events are compiled from public sources: company press releases and investor-relations pages, SEC filings, FDA communications and ClinicalTrials.gov, plus first-tier financial newswires. Estimated windows are marked as such. Nothing here is a recommendation; entries should always be confirmed against primary sources before use.
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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.