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SNDX FDA Decision Approved · 2025-10-24

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 10/24/25$17.04$8.735/9/25
Daily close, T-120 (5/9/25) through T+5. Run-up high $17.04 on 9/5/25, low $8.73 on 7/8/25 (T-120 to T-1). FDA decision 10/24/25. Historical price action, not a forecast.
Positioning before the decision
On Oct 10, 2025, 14 days before the decision date, at-the-money options priced a move of ±26.9% through Nov 21, 2025 (the first listed expiry after the decision; ATM implied volatility 100%). The stock closed -7.8% at the first close across the decision and -8.8% 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 date2025-10-24
DrugRevuforj (revumenib) - (AUGMENT-101)
IndicationRelapsed/refractory (R/R) acute leukemias
Outcome✓ Approvedprimary-sourced
Decision-day move-7.8%
T-120 run-up (low→high)+85.0% ($8.73→$17.04)
Market-cap tierSmall
Cohort decision-day move (history)3.6% median (n=280)

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 Revuforj (revumenib) - (AUGMENT-101) approved by the FDA?

Yes. The FDA approved the application for Revuforj (revumenib) - (AUGMENT-101) on October 24, 2025. The primary source is linked on this page.

What was Revuforj (revumenib) - (AUGMENT-101) under FDA review for?

The application covered Relapsed/refractory (R/R) acute leukemias. The FDA approved the application on October 24, 2025.

How did SNDX stock react to the FDA decision?

On the decision day SNDX moved -7.8%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.