Efficacy CRL, 2nd CRL (Jan 2026): FDA no longer deemed the single-arm Phase 3 ALLELE data adequate for accelerated approval and called for a new study; the earlier GMP issue was resolved.
Price into the decision (T-120)
Daily close, T-120 (7/28/25) through T+5. Run-up high $18.09 on 1/1/26, low $10.32 on 8/15/25 (T-120 to T-1). FDA decision 1/12/26. Historical price action, not a forecast.
Decision facts
FDA decision date2026-01-12
Outcome✗ CRL✓ source-verified
Decision-day move-57.0%
T-120 run-up (low→high)+54.0% ($4.37→$18.09)
CRL reasonEfficacy, 2nd CRL (Jan 2026): FDA no longer deemed the single-arm Phase 3 ALLELE data adequate for accelerated approval and called for a new study; the earlier GMP issue was resolved.
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.