ETON – ET-600 oral desmopressin melt PDUFA – February 25, 2026
Eton Pharmaceuticals’ ET-600 is an oral transmucosal desmopressin formulation for nocturnal polyuria.
The FDA has accepted the NDA with a standard review and set a PDUFA date of February 25, 2026. The
filing is backed by a bioequivalence programme versus existing desmopressin formulations and a
single-dose safety profile designed to minimise hyponatraemia risk in older adults.
Key sources:
-
Eton Pharmaceuticals press release announcing NDA acceptance and PDUFA date of February 25, 2026.
ASND – TransCon CNP PDUFA in achondroplasia – February 28, 2026
Ascendis Pharma’s TransCon CNP is a long-acting CNP prodrug for achondroplasia. After an initial
deferral driven by manufacturing questions, the FDA has extended the review and set a new PDUFA
date of February 28, 2026. Phase 2 and Phase 3 data have shown sustained improvements in annualised
growth velocity, body proportions and secondary outcomes in paediatric patients.
Key sources:
-
Ascendis Pharma regulatory update confirming extended PDUFA date of February 28, 2026 for TransCon CNP.
CVAC – Phase 2 mRNA trial in newly diagnosed glioblastoma – February 4, 2026
CureVac is running a Phase 2 study of an mRNA-based immunotherapy in newly diagnosed glioblastoma,
testing whether personalised neoantigen vaccines can prolong progression-free survival on top of
standard chemoradiotherapy. Preliminary February data are expected to focus on safety, immune
activation and early PFS trends; any clear signal here would help validate the CNS arm of the
company’s oncology platform.
Note: timing and exact dataset size come from conference and catalyst calendars and should be
re-checked against official CureVac communications or meeting abstracts closer to the date.
XCUR – Burixafor (GPC-100) Phase 2 multiple myeloma data – February 5, 2026
Exicure (via the legacy GPC partnership) is developing Burixafor, an oral CXCR4 antagonist, for
multiple myeloma and stem-cell mobilisation. Updated Phase 2 data around February 5 are expected
to include response rates and safety profile in combination with standard backbones, building on
prior evidence that deeper CXCR4 blockade can improve marrow trafficking and chemosensitivity.
Key sources:
-
Company clinical update and third-party coverage indicating a February 5 data presentation window.
ILMN – FY 2025 earnings and 2026 outlook – February 5, 2026
Illumina is scheduled to report fourth-quarter and full-year 2025 results on February 5, 2026,
with a focus on NovaSeq X placements, core sequencing consumables growth and progress on divesting
or restructuring non-core assets. For biotech investors, the call is a read-through on broader
genomics capital spending and clinical sequencing trends into 2026.
Key sources:
-
Illumina investor relations calendar – Q4 2025 and FY 2025 earnings call set for February 5, 2026.
RGNX – RGX-121 PDUFA in neuronopathic Hunter syndrome – February 8, 2026
Clemidsogene lanparvovec (RGX-121) is REGENXBIO’s AAV gene therapy for severe neuronopathic Hunter
syndrome (MPS II). The BLA was accepted with Priority Review, and the original PDUFA date of
November 9, 2025 was subsequently extended by the FDA to February 8, 2026 to allow review of
additional longer-term CAMPSIITE data. This action date is a major binary event for the programme,
testing how the agency weighs single-arm gene therapy data in an ultra-rare neurodegenerative
disease and the durability of benefit in treated children.
AZN – Q4 2025 earnings and oncology pipeline update – February 10, 2026
AstraZeneca plans to report fourth-quarter and full-year 2025 results on February 10, 2026. Beyond
headline revenue and EPS, investors will focus on updated numbers for Tagrisso, Enhertu, Datopotamab
deruxtecan and the broader ADC and immuno-oncology portfolio, as well as any new guidance on R&D
spend and late-stage readouts for 2026.
Key sources:
-
AstraZeneca corporate calendar – “Fourth quarter and full year 2025 results” scheduled for February 10, 2026.
EGRX – CAL02 Phase 2 data in severe bacterial pneumonia
Eagle Pharmaceuticals is co-developing CAL02, a first-in-class anti-toxin liposomal agent for severe
bacterial pneumonia. February 2026 is the current window for a Phase 2 readout assessing mortality
and ventilator-free days on top of standard-of-care antibiotics in ICU patients. A clean safety
profile plus even modest efficacy could open a new mechanism in resistant Gram-positive and
Gram-negative infections.
Note: exact day is based on external catalyst calendars; always reconfirm in the company’s own newsflow.
XOMA / GOSS – Seralutinib Phase 3 PROSERA topline in PAH – mid-February 2026 window
Gossamer Bio and XOMA are partnered on seralutinib, an inhaled PDGFR/CSF1R/Colony-stimulating
receptor inhibitor for pulmonary arterial hypertension (PAH). The PROSERA Phase 3 trial is designed
to demonstrate improvements in 6-minute walk distance and risk scores versus background therapy. A
mid-February topline window would be a major binary event for both GOSS and the XOMA royalty stream.
Key sources:
-
Company and partner updates outlining completion of Phase 3 enrolment and guidance for a 2026 topline readout.
GLUE – MRT-2359 Phase 1/2 MYC-driven solid tumour update
Monte Rosa Therapeutics’ MRT-2359 is a targeted protein degrader of GSPT1 in MYC-driven solid tumours.
The ongoing Phase 1/2 trial explores multiple schedules and combination strategies; a February 2026
update is expected to add more patients at the 0.5–0.75 mg cohorts, with a focus on durability of
responses and tolerability as doses increase.
Key sources:
-
Monte Rosa development update on MRT-2359 and ongoing Phase 1/2 trial in MYC-driven solid tumours.
CAPR – Deramiocel BLA path in Duchenne muscular dystrophy
After a prior Complete Response Letter on its cell-therapy candidate Deramiocel in Duchenne muscular
dystrophy, Capricor is working with the FDA on a resubmission strategy that may involve additional
CMC work and updated long-term clinical data. Mid-February has been flagged by several catalyst
calendars as a window for clarity on the BLA path, but investors should view this as indicative
only until confirmed by formal company communication.
REGN – Dupixent BLA filing in fungal chronic rhinosinusitis – late February focus
Regeneron and Sanofi are exploring Dupixent in multiple inflammatory indications, including fungal
chronic rhinosinusitis with nasal polyposis. A late-February 2026 window is being monitored for a
potential BLA submission or detailed Phase 3 update in this setting, which would further broaden
Dupixent’s anti-type-2 inflammation footprint if successful.
Note: timeline here is based mainly on Street expectations and conference commentary; treat it as
a soft catalyst until a formal filing announcement is made.
MRK – Keytruda ovarian cancer label expansion – February 2026 PDUFA window
Merck is pursuing multiple label expansions for Keytruda, including combinations in ovarian cancer.
The February 2026 entry in this calendar reflects an expected FDA decision window for one of these
supplemental applications, based on external PDUFA trackers and analyst commentary rather than a
formally disclosed PDUFA date.
Note: treat timing as indicative only and verify against Merck’s own regulatory updates and FDA databases.
ADCT – Loncastuximab tesirine (Zynlonta) in relapsed/refractory DLBCL
Loncastuximab tesirine is ADC Therapeutics’ CD19-directed antibody–drug conjugate, approved as
Zynlonta for relapsed or refractory diffuse large B-cell lymphoma after at least two prior lines
of therapy. Current development focuses on earlier lines of treatment and combinations with
standard backbones, aiming to broaden the label and move the drug up in the treatment sequence.
February 2026 read-through: this calendar entry reflects external catalyst trackers that flag
a February window for updated clinical data or programme guidance in DLBCL. Investors should confirm
the exact timing and dataset against ADC Therapeutics’ own press releases, presentations and SEC filings.
ANRO – ALTO-101 in major depressive disorder
Alto Neuroscience is developing ALTO-101, an oral molecule targeting cyclic AMP signalling pathways,
for major depressive disorder. The programme is built around biomarker-guided psychiatry, where
patients are selected based on EEG and other markers that predict response to the mechanism.
February 2026 read-through: the February 1, 2026 entry represents a window for updated Phase 2
data or development guidance from the ALTO-101 depression programme. Exact dates and endpoints
should be re-checked in Alto’s clinical updates and any future SEC filings.
ARDX – Tenapanor in constipation / CF-focused study
Tenapanor is Ardelyx’s oral NHE3 inhibitor that reduces sodium absorption in the gut, approved as
Ibsrela for IBS-C and as Xphozah for hyperphosphataemia in CKD patients. Its mechanism makes it
a candidate for investigator-initiated studies in difficult-to-treat constipation, including
cystic fibrosis-related settings, where altered fluid balance and motility are key issues.
February 2026 read-through: the calendar entry reflects small-scale, early clinical work
exploring Tenapanor’s utility in CF-related constipation rather than a large registrational trial.
Investors should treat this as a soft catalyst and verify details in Ardelyx’s pipeline disclosures
and any associated clinical trial registries.
BHVN – BHV-7000 Kv7 activator in epilepsy and RNS
BHV-7000 is Biohaven’s oral Kv7 channel activator designed to dampen neuronal hyperexcitability with
a differentiated safety and tolerability profile versus older sodium-channel anti-seizure drugs.
The company is advancing BHV-7000 across focal onset seizures and other epileptic indications, with
parallel work on responsive neurostimulation (RNS) settings.
February 2026 read-through: February is flagged as a potential window for interim Phase 2
data and programme updates in focal onset seizures. The precise timing and depth of data should be
confirmed against Biohaven’s clinical newsflow and upcoming conference agendas.
BRNS – VTP-300 therapeutic vaccine in chronic hepatitis B
VTP-300 is a therapeutic vaccine platform designed to induce robust, multi-antigen T-cell responses
against hepatitis B virus, with the goal of driving patients toward functional cure when used on
top of standard-of-care nucleos(t)ide analogues. Early clinical data have shown reductions in HBsAg
in a subset of patients, with ongoing dose and schedule optimisation.
February 2026 read-through: the February 1, 2026 entry corresponds to expected updates from
mid-stage HBV trials, as flagged by third-party catalyst calendars. Investors should cross-check
the actual announcement dates on the company’s website and in clinical conference programmes.
CANF – Namodenoson (CF102) in advanced hepatocellular carcinoma
Namodenoson is Can-Fite’s oral A3 adenosine receptor agonist being developed for second-line
hepatocellular carcinoma, with Phase 3 work comparing it against standard therapies in patients
who have failed first-line systemic treatment. Prior Phase 2 data suggested a survival signal in
specific patient subgroups with preserved liver function.
February 2026 read-through: the February window indicates potential interim or top-line
updates from the Phase 3 programme, as referenced by external catalyst compendia. As always, the
exact timing and statistical strength of any readout must be confirmed in Can-Fite’s formal
releases and regulatory interactions.
CNSP – Berubicin in glioblastoma multiforme
Berubicin is a next-generation anthracycline designed to cross the blood–brain barrier, making it
a rare chemotherapy agent directly targeting malignant glioma cells. CNS Pharmaceuticals is running
a Phase 2 trial in glioblastoma multiforme to assess response rate, survival and safety versus
current standards of care.
February 2026 read-through: the February 1 entry marks a window in which interim survival
or response data could be shared, based on trial timelines and external catalyst trackers. Any
trading decision should be anchored to the actual data releases and regulatory commentary.
CPIX – Oral Ifetroban in diffuse cutaneous systemic sclerosis
Ifetroban is an oral thromboxane receptor antagonist being studied in diffuse cutaneous systemic
sclerosis and SSc-associated pulmonary arterial hypertension. The Phase 2 programme is designed
to look at skin score improvements, cardiopulmonary parameters and safety in a population with
high unmet need and limited effective options.
February 2026 read-through: the February 1 calendar entry reflects an anticipated update
from this Phase 2 work as recorded in clinical-trial and catalyst databases. Given the small and
heterogeneous patient cohorts, investors should treat early signals cautiously and verify details
in official trial publications.
DAWN – DAY101 / tovorafenib in paediatric low-grade glioma
Day One Biopharmaceuticals’ tovorafenib (DAY101) is an oral type II RAF inhibitor targeting BRAF-
altered paediatric low-grade glioma. The FIREFLY-1 trial has already shown substantial objective
response rates and durable disease control in heavily pre-treated children, supporting a potential
registration package.
February 2026 read-through: the February 1 entry in this calendar is tied to expected
follow-up data, regulatory milestones or label discussions derived from FIREFLY-1 and related
studies. Exact milestones should be confirmed via Day One’s investor updates and regulatory news.
IMCR – IMC-F106C PRAME-targeted ImmTAC in solid tumours
IMC-F106C is Immunocore’s ImmTAC (TCR bispecific) targeting the cancer–testis antigen PRAME,
designed to redirect T cells against PRAME-expressing solid tumours. The ongoing PRAME-02
programme includes multiple solid tumour cohorts, assessing response durability and safety in
patients with high unmet need.
February 2026 read-through: February is used here as a window for additional Phase 1/2
cohort data or expansion-cohort guidance, based on published trial timelines. For precise data
cuts and cohort composition, investors should rely on Immunocore’s formal trial updates and
conference presentations.
ARQT – Arcutis medical dermatology and Zoryve franchise
Arcutis Biotherapeutics focuses on topical, nonsteroidal therapies for chronic inflammatory skin
diseases. Its lead franchise, Zoryve (roflumilast), includes multiple formulations for plaque
psoriasis, seborrheic dermatitis and atopic dermatitis, aiming to deliver steroid-like efficacy
with a cleaner safety and tolerability profile suitable for long-term use.
February 2026 read-through: the February pipeline-update window in this calendar is linked
to ongoing lifecycle work around Zoryve and earlier-stage medical dermatology assets, as flagged
by Street notes and catalyst trackers. Before trading, investors should verify actual catalysts
against Arcutis’ own earnings materials, pipeline updates and regulatory disclosures.
BIOA – BioAge longevity and age-related disease programmes
BioAge is a longevity-focused biotech using multi-omics data and AI to identify pathways that drive
healthy ageing, then developing small-molecule or biologic drugs against those targets. Its
pipeline spans muscle weakness, immune ageing and metabolic disorders that become more prevalent
with age, with several clinical candidates exploring whether modulating these pathways can improve
resilience in older adults.
February 2026 read-through: the February 15 entry captures a generic pipeline update window
referenced in external calendars for new data or partnering moves around BioAge’s lead clinical
assets. Any concrete trading thesis should be cross-checked with the company’s own newsflow and
clinical-trial registries.
BTAI – BioXcel neuropsychiatry and oncology franchise (BXCL501-led)
BioXcel Therapeutics is developing BXCL501, a sublingual dexmedetomidine film, for acute agitation
in schizophrenia, bipolar disorder and Alzheimer’s disease, alongside additional neuropsychiatric
indications. The company also has an oncology arm using AI-enabled drug-repositioning and network
analysis to identify new combinations and mechanisms in solid tumours.
February 2026 read-through: this February pipeline-update slot refers to potential label
expansions, post-marketing data and strategic decisions around BXCL501, as well as progress in the
oncology portfolio. Given prior regulatory and governance scrutiny, investors should rely only on
official BioXcel filings, FDA documents and reputable conference presentations when sizing any
catalyst.
CNTB – Connect Biopharma T cell–driven immunology pipeline
Connect Biopharma develops therapies for T cell–driven inflammatory diseases, led by rademikibart
(CBP-201), an IL-4Rα–targeting antibody for atopic dermatitis, asthma and other allergic conditions.
The broader pipeline includes additional biologics aimed at modulating pathogenic T helper responses
in chronic inflammatory settings.
February 2026 read-through: the February 15 entry reflects an expected window for data or
strategic updates around rademikibart late-stage studies and next steps in broader immunology
indications, based on external catalyst trackers. Exact milestones should be confirmed against
Connect Biopharma’s own press releases and clinical-trial disclosures.
CRDF – Onvansertib in TNBC and KRAS-mutated colorectal cancer
Cardiff Oncology’s lead asset, onvansertib, is an oral PLK1 inhibitor being tested in combination
with chemotherapy and targeted agents across multiple tumour types. In triple-negative breast cancer
and KRAS-mutated metastatic colorectal cancer, the goal is to enhance chemosensitivity and deepen
responses by disrupting mitotic checkpoints in rapidly dividing tumour cells.
February 2026 read-through: the February calendar entry for onvansertib plus paclitaxel
in TNBC marks a potential data-update window inferred from trial timelines and Street commentary.
Investors should confirm the presence, size and quality of any dataset directly in Cardiff’s
clinical updates, conference abstracts and SEC filings.
CTMX – CytomX Probody® masked antibody platform
CytomX Therapeutics is advancing its Probody platform, which masks antibodies or T cell engagers
until they reach the tumour microenvironment, aiming to widen the therapeutic window for potent
immune-oncology mechanisms. Programmes include T cell engagers such as CX-904 and multiple masked
antibodies directed against solid tumour targets where systemic toxicity is a concern.
February 2026 read-through: the February 15 pipeline-update slot is associated with ongoing
Phase 1/2 dose-escalation data and potential partnering or reprioritisation decisions around key
Probody assets. For concrete details, investors should rely on CytomX’s own R&D updates and
high-quality conference presentations.
DYN – Dyne Therapeutics muscle disease portfolio (DM1, DMD and beyond)
Dyne Therapeutics uses its FORCE™ platform to deliver oligonucleotide therapeutics to muscle tissue,
with lead candidates in myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) exon
51–skippable mutations. Early clinical data have focused on safety, target engagement and functional
readouts such as myotonia and muscle strength in populations with few effective options.
February 2026 read-through: the February pipeline window in this calendar corresponds to
expected follow-up data from ongoing DM1 and DMD studies and potential expansion into additional
indications. As always, any thesis around DYN catalysts should be anchored in Dyne’s formal clinical
announcements and peer-reviewed or conference-level presentations.
FULC – Fulcrum sickle-cell and genetic disease portfolio
Fulcrum Therapeutics is developing small-molecule regulators of gene expression for serious genetic
diseases. Its sickle-cell programme, centred on the PKR activator pociredir, aims to improve
haemoglobin levels and reduce vaso-occlusive crises by enhancing red blood cell energy metabolism,
while earlier work in facioscapulohumeral muscular dystrophy and other indications targets disease-
driving transcriptional programs.
February 2026 read-through: the February 15 entry represents a generic pipeline-update
window for new clinical data, regulatory dialogue or strategic moves in sickle cell disease and
the broader Fulcrum portfolio, as inferred from external trackers. Investors should check the
exact nature of any February news directly in Fulcrum’s press releases, earnings materials and
SEC filings.
BCRX – BioCryst complement / HAE franchise
BioCryst focuses on oral small-molecule inhibitors of complement pathways and kallikrein for rare
diseases, led by Orladeyo for hereditary angioedema and a broader complement pipeline in renal and
systemic indications. Pipeline updates often centre on new indications, long-term safety data and
combinations with standard-of-care regimens.
February 2026 read-through: the February 15 pipeline-update slot is a generic window for
programme updates and incremental data; specific tradeable catalysts should always be verified
against BioCryst’s official newsflow and regulatory interactions.
DNLI – Denali neurodegeneration and blood–brain barrier platform
Denali Therapeutics develops therapies for neurodegenerative diseases, leveraging its Transport
Vehicle (TV) technology to move biologics across the blood–brain barrier. Its pipeline spans
Parkinson’s disease, Alzheimer’s and other CNS disorders, often in partnership with larger pharma
companies for late-stage development.
February 2026 read-through: the February entry captures a broad pipeline-update window
in which Denali may provide additional clarity on CNS programmes and partnered assets. Concrete
catalysts must be confirmed via Denali’s own R&D days, earnings calls and regulatory filings.
IBIO – iBio oncology and AI-driven discovery
iBio has repositioned itself as an AI-enhanced oncology discovery company, using computational
platforms to design immuno-oncology and targeted agents against difficult tumour targets. Its
early-stage pipeline is focused on preclinical and Phase 1 programmes in solid tumours, with
a heavy emphasis on partnering and platform validation.
February 2026 read-through: the February 15 pipeline-update entry is intended as a soft
window for platform updates, early clinical readouts or new collaborations, rather than a single
binary event. As usual, investors should anchor any expectations to official iBio disclosures and
regulatory documentation.
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