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ATRA FDA Decision CRL · 2025-01-16

Page updated October 14, 2026·next FDA decision on the calendar ·Data as of Oct 14, 2026 7:39 PM ET

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 →

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Specialist biotech funds holding ATRA, 13F for the quarter ended June 30, 2026

Fund	Shares	Value at quarter end	Filing
EcoR1 Capital	1,552,000	$17.8 million	filed August 14, 2026
Redmile Group	441,701	$5.1 million	filed August 14, 2026

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 source-verified approved by the FDA?

Not in this review cycle. A Complete Response Letter, declining to approve the application for source-verified in its current form, was announced on January 16, 2025. 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.