ATRA FDA Decision CRL · 2025-01-16 Updated August 8, 2026 · next FDA decision on the calendar inspection CRL: Ebvallo CRL: third-party manufacturer inspection findings
Price into the decision (T-120) PDUFA 1/16/25 $18 $6.81 8/1/24 Daily close, T-120 (8/1/24) through T+5. Run-up high $18 on 1/7/25, low $6.81 on 9/9/24 (T-120 to T-1). FDA decision 1/16/25. Historical price action, not a forecast.
Decision facts FDA decision date 2025-01-16
Outcome ✗ CRL ✓ source-verified
Decision-day move -40.5%
T-120 run-up (low→high) +109.0% ($6.57→$18.0)
CRL reason inspection: Ebvallo CRL: third-party manufacturer inspection findings
Market-cap tier Micro
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.
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