Daily close, T-120 (10/28/24) through T+5. Run-up high $53.16 on 2/20/25, low $38.42 on 10/31/24 (T-120 to T-1). FDA decision 4/14/25. Historical price action, not a forecast.
Positioning before the decision
On Mar 31, 2025, 14 days before the decision date, at-the-money options priced a move of ±9.4% through Apr 17, 2025 (the first listed expiry after the decision; ATM implied volatility 82%). The stock closed +0.0% at the first close across the decision and -3.0% 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 date2025-04-14
DrugLIVMARLI (maralixibat) (tablet formulation)
IndicationAlagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
Was LIVMARLI (maralixibat) (tablet formulation) approved by the FDA?
Yes. The FDA approved the application for LIVMARLI (maralixibat) (tablet formulation) on April 14, 2025. The primary source is linked on this page.
What was LIVMARLI (maralixibat) (tablet formulation) under FDA review for?
The application covered Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). The FDA approved the application on April 14, 2025.
How did MIRM stock react to the FDA decision?
On the decision day MIRM moved +0.0%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.