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.
14 pdufa dates tracked, next on Nov 14, 2026. Event dates and source records are shown with their available source context.
PDUFA: jideytro
Nuvalent, Inc. (NUVL)
PDUFA: lytenava
Outlook Therapeutics, Inc. (OTLK)
PDUFA: fexofenadine
DR REDDYS LABORATORIES LTD (RDY)
PDUFA: deramiocel
CAPRICOR THERAPEUTICS, INC. (CAPR)
PDUFA: rasonque
REVOLUTION MEDICINES, INC. (RVMD)
PDUFA: pomalidomide
DR REDDYS LABORATORIES LTD (RDY)
PDUFA: pixclara
Telix Pharmaceuticals Limited (TLX)
PDUFA: ivonescimab
Summit Therapeutics Inc. (SMMT)
PDUFA: lorundrostat
Mineralys Therapeutics, Inc. (MLYS)
PDUFA: relutrigine
Praxis Precision Medicines, Inc. (PRAX)
PDUFA: 0001193125-26-308343
Dyne Therapeutics, Inc. (DYN)
PDUFA: 0001689548-26-000033
Praxis Precision Medicines, Inc. (PRAX)
PDUFA: 0001193125-26-411011
Cullinan Therapeutics, Inc. (CGEM)
PDUFA: 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: How to Verify a Resubmission Timeline
Separate CRL remediation from the FDA review clock. Check the original letter, resubmission receipt, Class 1 or Class 2 designation, and confirmed goal date.
FDA Priority Review: Timing vs. Approval Probability
Check the correct FDA review clock, separate a PDUFA action goal from approval odds, and audit the timing and probability assumptions in a biotech valuation.
Key terms
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