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Home › FDA Decisions › MIST 2025-03-28

MIST FDA Decision CRL · 2025-03-28

CMC/manufacturing CRL — Etripamil CRL — nitrosamine impurities + facility inspection

Price into the decision (T-120)

$2.36$0.8
Historical price action; green = local high, red = low/sell-off.

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 ↗
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