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MIST FDA Decision CRL · 2025-03-28

Updated ·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$1.4310/11/24
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.
Positioning before the decision
On Mar 14, 2025, 14 days before the decision date, at-the-money options priced a move of ±71.6% through Apr 17, 2025 (the first listed expiry after the decision; ATM implied volatility 285%). The stock closed -60.9% at the first close across the decision and -66.7% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.

Decision facts

FDA decision date2025-03-28
Outcome✗ CRL✓ source-verified
Decision-day move-60.9%
T-120 run-up (low→high)+30.0% ($0.8→$2.41)
CRL reasonCMC/manufacturing: Etripamil CRL: nitrosamine impurities + facility inspection
Primary sourceView filing ↗
Market-cap tierNano
Cohort decision-day move (history)8.0% median (n=117)

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 March 28, 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 MIST stock react to the FDA decision?

On the decision day MIST moved -60.9%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.