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 (6/16/25) through T+5. Run-up high $12.52 on 11/27/25, low $7.75 on 6/19/25 (T-120 to T-1). FDA decision 12/1/25. Historical price action, not a forecast.
Positioning before the decision
On Nov 17, 2025, 14 days before the decision date, at-the-money options priced a move of ±15.7% through Dec 19, 2025 (the first listed expiry after the decision; ATM implied volatility 117%). The stock closed -1.7% at the first close across the decision and -2.7% 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 date2025-12-01
OutcomeUnconfirmed · price consistent with approval~ price-only (validating)
Decision-day move-1.7%
T-120 run-up (low→high)+55.0% ($7.82→$12.52)
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierMicro
Cohort decision-day move (history)4.6% median (n=308)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.