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ENGN FDA Decision CRL · 2025-11-11

Page updated November 5, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

Mislabel: LEGEND clinical CR-rate data, BLA not filed

Price into the decision (T-120)

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)4.7% median (n=312)

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 ENGN, 13F for the quarter ended June 30, 2026

Fund	Shares	Value at quarter end	Filing
Perceptive Advisors	4,822,169	$8.3 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 November 11, 2025. 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.