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 (6/23/25) through T+5. Run-up high $18.09 on 12/5/25, low $8.24 on 9/24/25 (T-120 to T-1). FDA decision 12/8/25. Historical price action, not a forecast.
Decision facts
FDA decision date2025-12-08
OutcomeUnconfirmed · price consistent with a CRL~ price-only (validating)
Decision-day move+18.7%
T-120 run-up (low→high)+105.0% ($8.24→$21.47)
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.