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MIST FDA Decision CRL · 2025-03-28

Page updated ·next FDA decision on the calendar ·Data as of Nov 12, 2026 2:24 AM ET
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=122)

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 →

Specialist biotech funds holding MIST, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
RTW Investments7,833,336$10.5 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

Was source-verified approved by the FDA?

Not in this review cycle. A Complete Response Letter, declining to approve the application for source-verified in its current form, was announced on March 28, 2025. 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.