MIST FDA Decision CRL · 2025-03-28 Updated August 8, 2026 · next FDA decision on the calendar CMC/manufacturing CRL: Etripamil CRL: nitrosamine impurities + facility inspection
Price into the decision (T-120) PDUFA 3/28/25 $2.41 $1.43 10/11/24 Daily close, T-120 (10/11/24) through T+5. Run-up high $2.41 on 3/17/25, low $1.43 on 11/1/24 (T-120 to T-1). FDA decision 3/28/25. Historical price action, not a forecast.
Decision facts FDA decision date 2025-03-28
Outcome ✗ CRL ✓ source-verified
Decision-day move -60.9%
T-120 run-up (low→high) +30.0% ($0.8→$2.41)
CRL reason CMC/manufacturing: Etripamil CRL: nitrosamine impurities + facility inspection
Market-cap tier Nano
Cohort decision-day move (history) 8.0% median (n=116)
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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