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.
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.
Not in this review cycle. On January 12, 2026 the FDA issued a Complete Response Letter, declining to approve the application for EBVALLO in its current form. A CRL is not final; the primary source is linked on this page.
How did ATRA stock react to the FDA decision?
On the decision day ATRA moved -57.0%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.