PDUFA Dates
PDUFA (Prescription Drug User Fee Act) dates are the deadlines by which the FDA must complete its review of drug applications. These are the most-watched catalysts in biotech investing, often causing 50-200% stock price moves.
24 pdufa dates tracked, next on Sep 22, 2026. Event dates and source records are shown with their available source context.
PDUFA Date: ctx-1301
Cingulate Inc. (CING)
FDA Decision: vp bla
DBV Technologies S.A. (DBVT)
PDUFA Date: vepdegestrant
ARVINAS, INC. (ARVN)
FDA Decision: prednisone
DR REDDYS LABORATORIES LTD (RDY)
FDA Decision: trutakna
Vera Therapeutics, Inc. (VERA)
FDA Decision: senti-202
Senti Biosciences, Inc. (SNTI)
FDA Decision: jideytro
Nuvalent, Inc. (NUVL)
FDA Decision: lytenava
Outlook Therapeutics, Inc. (OTLK)
PDUFA Date: ons-5010
Outlook Therapeutics, Inc. (OTLK)
FDA Decision: zenbexus
BRISTOL MYERS SQUIBB CO (BMY)
FDA Decision: pasatru
REGENERON PHARMACEUTICALS, INC. (REGN)
PDUFA Date: deramiocel
CAPRICOR THERAPEUTICS, INC. (CAPR)
PDUFA Date: dtx401 aav gene therapy
Ultragenyx Pharmaceutical Inc. (RARE)
PDUFA Date: deramiocel
CAPRICOR THERAPEUTICS, INC. (CAPR)
PDUFA Date: zilganersen
IONIS PHARMACEUTICALS INC (IONS)
PDUFA Date: ino-3107
INOVIO PHARMACEUTICALS, INC. (INO)
PDUFA Date: igalmi
BioXcel Therapeutics, Inc. (BTAI)
PDUFA Date: ivonescimab
Summit Therapeutics Inc. (SMMT)
PDUFA Date: deramiocel
CAPRICOR THERAPEUTICS, INC. (CAPR)
PDUFA Date: lorundrostat
Mineralys Therapeutics, Inc. (MLYS)
PDUFA Date: relutrigine
Praxis Precision Medicines, Inc. (PRAX)
Revised from Sep 27, 2026
PDUFA Date: zeleciment rostudirsen (z-rostudirsen
Dyne Therapeutics, Inc. (DYN)
PDUFA Date: ulixacaltamide hcl
Praxis Precision Medicines, Inc. (PRAX)
PDUFA Date: ozekibart
Inhibrx Biosciences, Inc. (INBX)
Frequently asked questions
What is a PDUFA date?
A PDUFA (Prescription Drug User Fee Act) date is the deadline by which the FDA must complete its review of a drug application and issue a decision — either an approval or a Complete Response Letter.
Why do PDUFA dates move biotech stocks?
A PDUFA decision is a binary regulatory event: approval can unlock a drug's commercial revenue while a Complete Response Letter delays it, frequently causing 50-200% single-day stock moves.
How current is the PDUFA calendar?
Event dates and source records are shown with their available source context.
Learn more
What Is PDUFA? A Complete Guide for Biotech Investors
Understand PDUFA dates, how the FDA review process works, and why PDUFA action dates are the most important catalysts in biotech investing.
FDA Complete Response Letters (CRLs): What They Mean for Biotech Investors
Learn what a Complete Response Letter is, why the FDA issues CRLs, how companies respond, and what CRL outcomes mean for biotech stock prices and timelines.
FDA Priority Review vs. Standard Review: What the Difference Means for Biotech Investors
Compare FDA Priority Review and Standard Review timelines, learn what triggers each designation, and understand how review type affects drug approval probability and stock prices.
Key terms
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