PDUFA Dates
FDA target action dates — the deadline by which the FDA must decide on a drug application. The single most-watched binary catalyst in biotech.
October 20264
November 202610
December 20269
FDA PDUFA Date AVT16 (vedolizumab biosimilar) (standard review)
January 20278
February 202711
FDA PDUFA Date Lunsumio VELO (mosunetuzumab) in combination with Polivy (polatuzumab vedotin) (accelerated review)
FDA PDUFA Date uniQure Huntington's disease gene therapy (accelerated review)
FDA PDUFA Date olanzapine extended-release injectable suspension (standard review)
March 20273
April 20273
FDA PDUFA Date Trastuzumab Pamirtecan (T-Pam, DB-1303, BNT323)
May 20277
June 20276
July 20271
August 20275
September 20274
About PDUFA Dates
A PDUFA date is the deadline by which the U.S. Food and Drug Administration must take action on a New Drug Application (NDA) or Biologics License Application (BLA). It is named after the Prescription Drug User Fee Act, under which companies pay a fee in exchange for the FDA committing to a review timeline.
Standard reviews carry a 10-month goal date (12 months from submission); Priority Review — granted to drugs that offer a significant improvement over existing options — shortens that to 6 months (8 from submission). On or before the PDUFA date the FDA issues one of three outcomes: an approval, a Complete Response Letter (CRL) identifying deficiencies, or, occasionally, an extension of the review clock.
Why PDUFA Dates matter to investors
PDUFA dates are binary, scheduled events, which makes them the most tradable catalyst in biotech. An approval can re-rate a stock overnight; a CRL or unexpected delay can cut a small-cap in half. Because the date is known in advance, options-implied volatility and pre-decision run-ups build around it — which is exactly why investors track a live PDUFA calendar.
Frequently asked questions
What is a PDUFA date?
A PDUFA date is the FDA’s target deadline to decide on a drug application under the Prescription Drug User Fee Act. Standard reviews target 10 months; Priority Reviews target 6 months.
What happens on a PDUFA date?
The FDA issues one of three outcomes: approval, a Complete Response Letter (CRL) listing deficiencies, or an extension of the review period. The decision often arrives on or shortly before the date, and sometimes early.
Do PDUFA dates move stock prices?
Yes — they are binary regulatory events. Approvals frequently drive sharp gains and CRLs or delays sharp losses, so PDUFA dates are among the highest-impact biotech catalysts.
Can a PDUFA date change?
Yes. The FDA can extend the date (commonly by three months) if a company submits a major amendment, or act before it. CatalystAlert labels each date confirmed, estimated, or AI-detected so you know how firm it is.