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BioSniper ranking

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.

Ranked entities
10
Freshness
No verified data date available
Method
Published source data
BioSniper AIPage evidence connected

Prepared research question

Why is PDUFA Date: zilganersen — Next FDA Decisions (PDUFA & AdCom) → IONS in this position, and what could change the ranking?

Run cited research

Traceable citations · Unknowns marked

  1. 1PDUFA Date: zilganersenIONIS PHARMACEUTICALS INC (IONS)Sep 22, 2026PDUFA
  2. 2PDUFA Date: ino-3107INOVIO PHARMACEUTICALS, INC. (INO)Oct 30, 2026PDUFA
  3. 3PDUFA Date: ivonescimabSummit Therapeutics Inc. (SMMT)Nov 14, 2026PDUFA
  4. 4PDUFA Date: igalmiBioXcel Therapeutics, Inc. (BTAI)Nov 14, 2026PDUFA
  5. 5PDUFA Date: deramiocelCAPRICOR THERAPEUTICS, INC. (CAPR)Nov 22, 2026PDUFA
  6. 6PDUFA Date: lorundrostatMineralys Therapeutics, Inc. (MLYS)Dec 22, 2026PDUFA
  7. 7PDUFA Date: relutriginePraxis Precision Medicines, Inc. (PRAX)Dec 27, 2026PDUFA
  8. 8PDUFA Date: zeleciment rostudirsen (z-rostudirsenDyne Therapeutics, Inc. (DYN)Jan 21, 2027PDUFA
  9. 9PDUFA Date: ulixacaltamide hclPraxis Precision Medicines, Inc. (PRAX)Jan 29, 2027PDUFA
  10. 10PDUFA 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?

Event dates and source records are shown with their available source context. Only dates that appear in a primary source are shown.

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