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AMRX FDA Decision Approved · 2025-09-04

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 9/4/25$9.59$6.973/20/25
Daily close, T-120 (3/20/25) through T+5. Run-up high $9.59 on 8/25/25, low $6.97 on 4/17/25 (T-120 to T-1). FDA decision 9/4/25. Historical price action, not a forecast.
Positioning before the decision
On Aug 21, 2025, 14 days before the decision date, at-the-money options priced a move of ±7.9% through Sep 19, 2025 (the first listed expiry after the decision; ATM implied volatility 60%). The stock closed +0.1% at the first close across the decision and +2.9% 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 date2025-09-04
DrugRisperidone Extended-Release
IndicationSchizophrenia
Outcome✓ Approvedprimary-sourced
Decision-day move+0.1%
T-120 run-up (low→high)+28.0% ($7.16→$9.62)
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 Risperidone Extended-Release approved by the FDA?

Yes. The FDA approved the application for Risperidone Extended-Release on September 4, 2025. The primary source is linked on this page.

What was Risperidone Extended-Release under FDA review for?

The application covered Schizophrenia. The FDA approved the application on September 4, 2025.

How did AMRX stock react to the FDA decision?

On the decision day AMRX moved +0.1%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.