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