UNCY FDA Decision CRL · 2025-06-30 Updated August 8, 2026 · next FDA decision on the calendar inspection CRL, OLC NDA CRL: third-party vendor cGMP inspection deficiency
Price into the decision (T-120) PDUFA 6/30/25 $9 $4.61 1/13/25 Daily close, T-120 (1/13/25) through T+5. Run-up high $9 on 6/10/25, low $4.61 on 4/10/25 (T-120 to T-1). FDA decision 6/30/25. Historical price action, not a forecast.
Decision facts FDA decision date 2025-06-30
Outcome ✗ CRL ✓ source-verified
Decision-day move -29.9%
T-120 run-up (low→high) +57.0% ($4.6→$9.0)
CRL reason inspection, OLC NDA CRL: third-party vendor cGMP inspection deficiency
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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