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.
Updated weekly · 4 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.
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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