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JAZZ FDA Decision Approved · 2025-08-06

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 8/6/25$144.17$97.782/19/25
Daily close, T-120 (2/19/25) through T+5. Run-up high $144.17 on 3/4/25, low $97.78 on 5/14/25 (T-120 to T-1). FDA decision 8/6/25. Historical price action, not a forecast.
Positioning before the decision
On Jul 23, 2025, 14 days before the decision date, at-the-money options priced a move of ±10.3% through Aug 15, 2025 (the first listed expiry after the decision; ATM implied volatility 51%). The stock closed -6.4% at the first close across the decision and +0.1% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.

Decision facts

FDA decision date2025-08-06
DrugDordaviprone (ONC201) - (ACTION)
IndicationH3 K27M-mutant diffuse midline glioma
Outcome✓ Approvedprimary-sourced
Decision-day move-6.4%
T-120 run-up (low→high)+9.0% ($97.78→$100.05)
Market-cap tierMid
Cohort decision-day move (history)2.1% median (n=234)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

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Questions

Was Dordaviprone (ONC201) - (ACTION) approved by the FDA?

Yes. The FDA approved the application for Dordaviprone (ONC201) - (ACTION) on August 6, 2025. The primary source is linked on this page.

What was Dordaviprone (ONC201) - (ACTION) under FDA review for?

The application covered H3 K27M-mutant diffuse midline glioma. The FDA approved the application on August 6, 2025.

How did JAZZ stock react to the FDA decision?

On the decision day JAZZ moved -6.4%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.