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 (4/8/25) through T+5. Run-up high $42.86 on 7/18/25, low $24.47 on 4/15/25 (T-120 to T-1). FDA decision 9/23/25. Historical price action, not a forecast.
Positioning before the decision
On Sep 9, 2025, 14 days before the decision date, at-the-money options priced a move of ±26.9% through Oct 17, 2025 (the first listed expiry after the decision; ATM implied volatility 106%). The stock closed +3.6% at the first close across the decision and +17.7% 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 date2025-09-23
DrugApitegromab - (SAPPHIRE)
IndicationType 2 and Type 3 Spinal Muscular Atrophy (SMA)
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 Apitegromab approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for Apitegromab in its current form, was announced on September 23, 2025. A CRL is not final; the primary source is linked on this page.
What was Apitegromab under FDA review for?
The application covered Type 2 and Type 3 Spinal Muscular Atrophy (SMA). The FDA declined to approve the application in its current form on September 23, 2025.
How did SRRK stock react to the FDA decision?
On the decision day SRRK moved +3.6%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.