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Home › FDA Decisions › ENGN 2025-11-11

ENGN FDA Decision CRL · 2025-11-11

Updated ·next FDA decision on the calendar
Mislabel: LEGEND clinical CR-rate data, BLA not filed

Price into the decision (T-120)

PDUFA 11/11/25$9.35$2.995/27/25
Daily close, T-120 (5/27/25) through T+5. Run-up high $9.35 on 10/17/25, low $2.99 on 6/26/25 (T-120 to T-1). FDA decision 11/11/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-11-11
Outcome✗ CRL⚠ label corrected
Decision-day move+46.8%
T-120 run-up (low→high)+154.0% ($3.31→$9.35)
CRL reasonMislabel: LEGEND clinical CR-rate data, BLA not filed
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 November 11, 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 ENGN stock react to the FDA decision?

On the decision day ENGN moved +46.8%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.