ACHVAchieve Life Sciences — cytisinicline
Indication: Nicotine dependence / smoking cessation in adults
ORCA Phase 3 showed superior abstinence vs placebo; first new smoking cessation therapy in ~20 years if approved.
Updated weekly · 9 upcoming catalysts
2026 PDUFA Date Tracker
Upcoming FDA Prescription Drug User Fee Act target action dates for US-listed biotech and pharma sponsors. Sponsor, ticker, drug, indication, regulatory pathway, and clinical context — the catalysts that drive biotech stock moves.
LNTHLantheus Holdings — LNTH-2501 (Ga 68 edotreotide kit)
Indication: PET imaging of somatostatin receptor-positive neuroendocrine tumors
PDUFA extended 3 months from Mar 29 to Jun 29 for additional CMC review; not tied to safety/efficacy.
PFEPfizer — HYMPAVZI (marstacimab)
Indication: Expanded: hemophilia A/B patients 6+ with inhibitors and pediatric (6-11) without inhibitors
Expansion sBLA would make HYMPAVZI the first non-factor option for kids 6-11; FDA pushed decision from Q1 to Jun 29.
ARQTArcutis Biotherapeutics — ZORYVE (roflumilast) Cream 0.3%
Indication: Plaque psoriasis in children ages 2-5
Would make roflumilast the first topical PDE4 inhibitor labeled for plaque psoriasis down to age 2.
ORKAOrca Bio — Orca-T
Indication: AML, ALL, MDS requiring allogeneic stem cell transplant
First allogeneic cell therapy of its kind; Precision-T hit cGvHD-free survival endpoint. FDA extended PDUFA 3 months (CMC amendment).
CAPRCapricor Therapeutics — deramiocel
Indication: Duchenne muscular dystrophy (DMD) cardiomyopathy
CRL-resubmission after FDA lifted prior complete response letter; HOPE-3 Phase 3 hit primary PUL v2.0 plus LVEF endpoint.
PHAPharmaEssentia — Besremi (ropeginterferon alfa-2b-njft)
Indication: Essential thrombocythemia (ET) in adults
Label expansion from polycythemia vera into ET; SURPASS-ET showed 42.9% vs 6.0% mELN response vs anagrelide.
NUVLNuvalent — zidesamtinib (NVL-520)
Indication: TKI pre-treated locally advanced or metastatic ROS1-positive NSCLC
CNS-penetrant, TRK-sparing ROS1-selective inhibitor designed to overcome G2032R resistance; ARROS-1 data-backed.
IONSIonis Pharmaceuticals — zilganersen
Indication: Alexander disease (AxD) in children and adults
First disease-modifying therapy for ultra-rare fatal GFAP neurodegenerative disease; pivotal met primary gait-speed endpoint.
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