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
- 8
- Freshness
- No verified data date available
- Method
- Published source data
Prepared research question
Why is PDUFA: ivonescimab — Next FDA Decisions (PDUFA & AdCom) → SMMT in this position, and what could change the ranking?
Traceable citations · Unknowns marked
- 1PDUFA: ivonescimabSummit Therapeutics Inc. (SMMT)Nov 14, 2026PDUFA
- 2PDUFA: 0001104659-26-100071CAPRICOR THERAPEUTICS, INC. (CAPR)Nov 22, 2026PDUFA
- 3PDUFA: lorundrostatMineralys Therapeutics, Inc. (MLYS)Dec 22, 2026PDUFA
- 4PDUFA: relutriginePraxis Precision Medicines, Inc. (PRAX)Dec 27, 2026PDUFA
- 5PDUFA: 0001193125-26-308343Dyne Therapeutics, Inc. (DYN)Jan 21, 2027PDUFA
- 6PDUFA: 0001689548-26-000033Praxis Precision Medicines, Inc. (PRAX)Jan 29, 2027PDUFA
- 7PDUFA: 0001193125-26-411011Cullinan Therapeutics, Inc. (CGEM)Feb 27, 2027PDUFA
- 8PDUFA: 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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