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 (10/9/24) through T+5. Run-up high $16.44 on 11/18/24, low $8 on 10/16/24 (T-120 to T-1). FDA decision 3/26/25. Historical price action, not a forecast.
Positioning before the decision
On Mar 12, 2025, 14 days before the decision date, at-the-money options priced a move of ±30.9% through Apr 17, 2025 (the first listed expiry after the decision; ATM implied volatility 127%). The stock closed +6.1% at the first close across the decision and -18.0% 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.
Decision facts
FDA decision date2025-03-26
DrugWVE-N531 - (FORWARD-53)
IndicationDuchenne muscular dystrophy (DMD) in boys
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was WVE-N531 approved by the FDA?
Yes. The approval of the application for WVE-N531 was announced on March 26, 2025; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
What was WVE-N531 under FDA review for?
The application covered Duchenne muscular dystrophy (DMD) in boys. The FDA approved the application on March 26, 2025.
How did WVE stock react to the FDA decision?
On the decision day WVE moved +6.1%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.