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 (3/14/25) through T+5. Run-up high $59.35 on 3/14/25, low $45.64 on 7/31/25 (T-120 to T-1). FDA decision 8/29/25. Historical price action, not a forecast.
Positioning before the decision
On Aug 15, 2025, 14 days before the decision date, at-the-money options priced a move of ±7.4% through Sep 19, 2025 (the first listed expiry after the decision; ATM implied volatility 30%). The stock closed -0.9% at the first close across the decision and -6.9% 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 Wayrilz (rilzabrutinib) approved by the FDA?
Yes. The FDA approved the application for Wayrilz (rilzabrutinib) on August 29, 2025, per the FDA's own record. The primary source is linked on this page.
What was Wayrilz (rilzabrutinib) under FDA review for?
The application covered Immune thrombocytopenic purpura (ITP). The FDA approved the application on August 29, 2025.
How did SNY stock react to the FDA decision?
On the decision day SNY moved -0.9%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.