Daily close, T-120 (4/15/25) through T+5. Run-up high $129.73 on 9/5/25, low $101.96 on 4/15/25 (T-120 to T-1). FDA decision 9/30/25. Historical price action, not a forecast.
Positioning before the decision
On Sep 16, 2025, 14 days before the decision date, at-the-money options priced a move of ±4.7% through Oct 17, 2025 (the first listed expiry after the decision; ATM implied volatility 20%). The stock closed +3.3% at the first close across the decision and +6.6% 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.
Was Rhapsido (Remibrutinib )(LOU064) - (REMIX-1) approved by the FDA?
Yes. The FDA approved the application for Rhapsido (Remibrutinib )(LOU064) - (REMIX-1) on September 30, 2025. The primary source is linked on this page.
What was Rhapsido (Remibrutinib )(LOU064) - (REMIX-1) under FDA review for?
The application covered Chronic spontaneous urticaria (CSU). The FDA approved the application on September 30, 2025.
How did NVS stock react to the FDA decision?
On the decision day NVS moved +3.3%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.