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.
23 pdufa dates tracked, next on Jul 29, 2026. Updated .
PDUFA Date: tividenofusp alfa
Denali Therapeutics Inc. (DNLI)
PDUFA Date: rp1
Replimune Group, Inc. (REPL)
PDUFA Date: filspari
Travere Therapeutics, Inc. (TVTX)
PDUFA Date: daraxonrasib
Royalty Pharma plc (RPRX)
PDUFA Date: gtx-104 for formal review
Grace Therapeutics, Inc. (GRCE)
PDUFA Date: jakafi xr
Incyte Corp. (INCY)
PDUFA Date: veppanu
ARVINAS, INC. (ARVN)
PDUFA Date: venetoclax
DR REDDYS LABORATORIES LTD (RDY)
PDUFA Date: afrezza
MANNKIND CORP (MNKD)
PDUFA Date: ctx-1301
Cingulate Inc. (CING)
PDUFA Date: vepdegestrant
ARVINAS, INC. (ARVN)
PDUFA Date: ons-5010
Outlook Therapeutics, Inc. (OTLK)
PDUFA Date: deramiocel
CAPRICOR THERAPEUTICS, INC. (CAPR)
PDUFA Date: dtx401 aav gene therapy
Ultragenyx Pharmaceutical Inc. (RARE)
PDUFA Date: zilganersen
IONIS PHARMACEUTICALS INC (IONS)
PDUFA Date: relutrigine
Praxis Precision Medicines, Inc. (PRAX)
PDUFA Date: ino-3107
INOVIO PHARMACEUTICALS, INC. (INO)
PDUFA Date: igalmi
BioXcel Therapeutics, Inc. (BTAI)
PDUFA Date: ivonescimab
Summit Therapeutics Inc. (SMMT)
PDUFA Date: lorundrostat
Mineralys Therapeutics, Inc. (MLYS)
PDUFA Date: relutrigine
Praxis Precision Medicines, Inc. (PRAX)
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 often is the PDUFA calendar updated?
BioSniper's catalyst calendar is refreshed hourly from SEC filings, FDA sources, and company disclosures.
Learn more
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