SNSE FDA Decision CRL · 2025-10-17 Updated August 8, 2026 · next FDA decision on the calendar Mislabel: ESMO Phase 1/2 clinical data, clinical-stage
Price into the decision (T-120) PDUFA 10/17/25 $17.575 $5.9 5/2/25 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 date 2025-10-17
Outcome ✗ CRL ⚠ label corrected
Decision-day move -33.4%
T-120 run-up (low→high) +170.0% ($6.52→$17.58)
CRL reason Mislabel: ESMO Phase 1/2 clinical data, clinical-stage
Market-cap tier Micro
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.
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