Rebuilt daily·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
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)4.7% median (n=312)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was EBVALLO approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for EBVALLO in its current form, was announced on January 12, 2026. 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.