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ATRA FDA Decision CRL · 2025-01-16

Updated September 3, 2026·next FDA decision on the calendar

inspection CRL: Ebvallo CRL: third-party manufacturer inspection findings

Price into the decision (T-120)

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 date2025-01-16

Outcome✗ CRL✓ source-verified

Decision-day move-40.5%

T-120 run-up (low→high)+109.0% ($6.57→$18.0)

CRL reasoninspection: Ebvallo CRL: third-party manufacturer inspection findings

Primary sourceView filing ↗

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.

See the full 2026 PDUFA calendar →

Questions

Was source-verified approved by the FDA?

Not in this review cycle. On January 16, 2025 the FDA issued a Complete Response Letter, declining to approve the application for source-verified 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 -40.5%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.