Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
Price into the decision (T-120)
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.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was Risperidone Extended-Release approved by the FDA?
Yes. The FDA approved the application for Risperidone Extended-Release on September 11, 2025, per the FDA's own record. The company announced it 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.