Unverified record. The outcome below was inferred from the share-price reaction around this date. Nobody has confirmed it against an FDA, SEC or company document, and it may be wrong: we have published at least one inferred outcome that turned out to be impossible (see corrections). Treat it as a price observation, not as a regulatory fact. Verified decisions on this site always link a primary source.
Daily close, T-120 (4/8/25) through T+5. Run-up high $148.84 on 9/11/25, low $113.38 on 4/17/25 (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 ±5.7% through Sep 26, 2025 (the first listed expiry after the decision; ATM implied volatility 33%). The stock closed -1.0% at the first close across the decision and -1.5% 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
OutcomeUnconfirmed · price consistent with a CRL~ price-only (validating)
Decision-day move-1.0%
T-120 run-up (low→high)+18.0% ($122.68→$148.84)
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierLarge
Cohort decision-day move (history)1.0% median (n=835)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.