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SNSE FDA Decision CRL · 2025-10-17

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

Mislabel: ESMO Phase 1/2 clinical data, clinical-stage

Price into the decision (T-120)

Daily close, T-120 (5/2/25) through T+5. Run-up high $17.575 on 10/16/25, low $5.9 on 6/2/25 (T-120 to T-1). FDA decision 10/17/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-10-17

Outcome✗ CRL⚠ label corrected

Decision-day move-33.4%

T-120 run-up (low→high)+170.0% ($6.52→$17.58)

CRL reasonMislabel: ESMO Phase 1/2 clinical data, clinical-stage

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 October 17, 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 SNSE stock react to the FDA decision?

On the decision day SNSE moved -33.4%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.