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 $64.4 on 9/9/25, low $25.51 on 4/15/25 (T-120 to T-1). FDA decision 9/23/25. Historical price action, not a forecast.
Decision facts
FDA decision date2025-09-23
OutcomeUnconfirmed · price consistent with a CRL~ price-only (validating)
Decision-day move+2.0%
T-120 run-up (low→high)+94.0% ($32.43→$64.4)
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierMid
Cohort decision-day move (history)2.2% median (n=229)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.