Next FDA Decisions (PDUFA & AdCom)

PDUFA action dates and FDA Advisory Committee (AdCom) meetings are the most closely watched regulatory catalysts in biotech, frequently driving large single-day stock moves. This ranking lists the nearest upcoming FDA decisions first, so you can see what is coming next.

Top 12 · updated Jul 2, 2026.

  1. 1PDUFA Date: ons-5010Outlook Therapeutics, Inc. (OTLK)Jul 29, 2026PDUFA
  2. 2PDUFA Date: deramiocelCAPRICOR THERAPEUTICS, INC. (CAPR)Aug 22, 2026PDUFA
  3. 3PDUFA Date: dtx401 aav gene therapyUltragenyx Pharmaceutical Inc. (RARE)Aug 23, 2026PDUFA
  4. 4PDUFA Date: zilganersenIONIS PHARMACEUTICALS INC (IONS)Sep 22, 2026PDUFA
  5. 5PDUFA Date: relutriginePraxis Precision Medicines, Inc. (PRAX)Sep 27, 2026PDUFA
  6. 6PDUFA Date: ino-3107INOVIO PHARMACEUTICALS, INC. (INO)Oct 30, 2026PDUFA
  7. 7PDUFA Date: ivonescimabSummit Therapeutics Inc. (SMMT)Nov 14, 2026PDUFA
  8. 8PDUFA Date: igalmiBioXcel Therapeutics, Inc. (BTAI)Nov 14, 2026PDUFA
  9. 9PDUFA Date: lorundrostatMineralys Therapeutics, Inc. (MLYS)Dec 22, 2026PDUFA
  10. 10PDUFA Date: relutriginePraxis Precision Medicines, Inc. (PRAX)Dec 27, 2026PDUFA
  11. 11PDUFA Date: ulixacaltamide hclPraxis Precision Medicines, Inc. (PRAX)Jan 29, 2027PDUFA
  12. 12PDUFA Date: ozekibartInhibrx Biosciences, Inc. (INBX)Apr 14, 2027PDUFA

Ranked by soonest date. Only dates confirmed in a primary source (SEC filing, FDA source, or company disclosure) are shown; speculative far-future dates are excluded.

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 — an approval or a Complete Response Letter.

Is an AdCom vote binding on the FDA?

No — an Advisory Committee vote is advisory, though historically it predicts the FDA's final decision roughly 75–80% of the time.

How current is this ranking?

Upcoming FDA decisions are refreshed hourly from SEC filings, FDA sources, and company disclosures; only dates that appear in a primary source are shown.