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.
Historical price action; green = local high, red = low/sell-off.
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.