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 (11/12/24) through T+5. Run-up high $6.43 on 11/20/24, low $4.18 on 4/11/25 (T-120 to T-1). FDA decision 4/29/25. Historical price action, not a forecast.
Positioning before the decision
On Apr 15, 2025, 14 days before the decision date, at-the-money options priced a move of ±58.9% through May 16, 2025 (the first listed expiry after the decision; ATM implied volatility 258%). The stock closed -0.9% at the first close across the decision and +19.6% 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 ZEVASKYN (prademagene zamikeracel) approved by the FDA?
Yes. The approval of the application for ZEVASKYN (prademagene zamikeracel) was announced on April 29, 2025; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
What was ZEVASKYN (prademagene zamikeracel) under FDA review for?
The application covered Recessive dystrophic epidermolysis bullosa (RDEB). The FDA approved the application on April 29, 2025.
How did ABEO stock react to the FDA decision?
On the decision day ABEO moved -0.9%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.