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VSTM FDA Decision Approved · 2025-05-08

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 5/8/25$7.53$3.6711/21/24
Daily close, T-120 (11/21/24) through T+5. Run-up high $7.53 on 3/13/25, low $3.67 on 1/6/25 (T-120 to T-1). FDA decision 5/8/25. Historical price action, not a forecast.
Positioning before the decision
On Apr 24, 2025, 14 days before the decision date, at-the-money options priced a move of ±11.2% through May 16, 2025 (the first listed expiry after the decision; ATM implied volatility 110%). The stock closed +3.7% at the first close across the decision and +6.6% 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 date2025-05-08
DrugAVMAPKI FAKZYNJA CO-PACK
IndicationRecurrent low-grade serous ovarian cancer (LGSOC)
Outcome✓ Approvedprimary-sourced
Decision-day move+3.7%
T-120 run-up (low→high)+12.0% ($4.52→$7.53)
Market-cap tierMicro
Cohort decision-day move (history)4.6% median (n=308)

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 AVMAPKI FAKZYNJA CO-PACK approved by the FDA?

Yes. The FDA approved the application for AVMAPKI FAKZYNJA CO-PACK on May 8, 2025. The primary source is linked on this page.

What was AVMAPKI FAKZYNJA CO-PACK under FDA review for?

The application covered Recurrent low-grade serous ovarian cancer (LGSOC). The FDA approved the application on May 8, 2025.

How did VSTM stock react to the FDA decision?

On the decision day VSTM moved +3.7%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.