Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Price into the decision (T-120)
Daily close, T-120 (7/18/24) through T+5. Run-up high $65.72 on 8/6/24, low $53.35 on 12/24/24 (T-120 to T-1). FDA decision 1/2/25. Historical price action, not a forecast.
Positioning before the decision
On Dec 19, 2024, 14 days before the decision date, at-the-money options priced a move of ±10.4% through Jan 17, 2025 (the first listed expiry after the decision; ATM implied volatility 46%). The stock closed +0.3% at the first close across the decision and -2.0% 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 Prucalopride Tablets approved by the FDA?
Yes. The FDA approved the application for Prucalopride Tablets on December 26, 2024, per the FDA's own record. The company announced it on January 2, 2025. The primary source is linked on this page.
What was Prucalopride Tablets under FDA review for?
The application covered (RLD) Motegrity Biosimilar. The FDA approved the application on January 2, 2025.
How did ANIP stock react to the FDA decision?
On the decision day ANIP moved +0.3%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.