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Home › FDA Decisions › ALLO 2025-02-14

ALLO FDA Decision CRL · 2025-02-14

Updated ·next FDA decision on the calendar
Mislabel: Phase 1 data publication, clinical-stage

Price into the decision (T-120)

PDUFA 2/14/25$3.22$1.48/30/24
Daily close, T-120 (8/30/24) through T+5. Run-up high $3.22 on 11/13/24, low $1.4 on 2/11/25 (T-120 to T-1). FDA decision 2/14/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-02-14
Outcome✗ CRL⚠ label corrected
Decision-day move+44.7%
T-120 run-up (low→high)+22.0% ($1.4→$3.22)
CRL reasonMislabel: Phase 1 data publication, clinical-stage
Primary sourceView filing ↗
Market-cap tierMid
Cohort decision-day move (history)2.1% median (n=234)

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 February 14, 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 ALLO stock react to the FDA decision?

On the decision day ALLO moved +44.7%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.