Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Price into the decision (T-120)
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)
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 LIVMARLI (maralixibat) (tablet formulation) approved by the FDA?
Yes. The FDA approved the application for LIVMARLI (maralixibat) (tablet formulation) on April 10, 2025, per the FDA's own record. The company announced it 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.