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 (11/1/24) through T+5. Run-up high $941.39 on 11/1/24, low $546.39 on 4/11/25 (T-120 to T-1). FDA decision 4/20/25. Historical price action, not a forecast.
Positioning before the decision
On Apr 4, 2025, 16 days before the decision date, at-the-money options priced a move of ±9.8% through Apr 25, 2025 (the first listed expiry after the decision; ATM implied volatility 51%). The stock closed -0.3% at the first close across the decision and +7.0% 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 EYLEA HD (24-week dosing) approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for EYLEA HD (24-week dosing) in its current form, was announced on April 20, 2025. A CRL is not final; the primary source is linked on this page.
What was EYLEA HD (24-week dosing) under FDA review for?
The application covered Wet age-related macular degeneration (wAMD). The FDA declined to approve the application in its current form on April 20, 2025.
How did REGN stock react to the FDA decision?
On the decision day REGN moved -0.3%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.