Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
Price into the decision (T-120)
Daily close, T-120 (6/9/25) through T+5. Run-up high $132.39 on 10/3/25, low $113.5 on 8/7/25 (T-120 to T-1). FDA decision 11/24/25. Historical price action, not a forecast.
Positioning before the decision
On Nov 10, 2025, 14 days before the decision date, at-the-money options priced a move of ±5.4% through Dec 19, 2025 (the first listed expiry after the decision; ATM implied volatility 20%). The stock closed -0.6% at the first close across the decision and +1.3% 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 Itvisma (onasemnogene abeparvovec-brve) approved by the FDA?
Yes. The approval of the application for Itvisma (onasemnogene abeparvovec-brve) was announced on November 24, 2025; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
What was Itvisma (onasemnogene abeparvovec-brve) under FDA review for?
The application covered Spinal muscular atrophy (SMA). The FDA approved the application on November 24, 2025.
How did NVS stock react to the FDA decision?
On the decision day NVS moved -0.6%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.