Clinical/Endpoint CRL, Bitopertin (EPP): FDA wants the Phase 3 APOLLO result before deciding: the PPIX biomarker change isn't yet linked to sunlight-exposure benefit. Stock rose on relief / clear path.
Price into the decision (T-120)
Daily close, T-120 (8/29/25) through T+5. Run-up high $94.11 on 11/28/25, low $59.41 on 9/1/25 (T-120 to T-1). FDA decision 2/15/26. Historical price action, not a forecast.
Decision facts
FDA decision date2026-02-15
Outcome✗ CRL✓ source-verified
Decision-day move+17.2%
T-120 run-up (low→high)+29.0% ($55.95→$94.11)
CRL reasonClinical/Endpoint, Bitopertin (EPP): FDA wants the Phase 3 APOLLO result before deciding: the PPIX biomarker change isn't yet linked to sunlight-exposure benefit. Stock rose on relief / clear path.
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierSmall
Cohort decision-day move (history)3.6% median (n=279)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.