Rebuilt daily·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Aficamten (MYQORZO) was FDA-APPROVED Dec 19, 2025; the CRL label on this date appears to be a data error; treat as approved.
Price into the decision (T-120)
Daily close, T-120 (5/23/25) through T+5. Run-up high $63.59 on 10/31/25, low $30.28 on 6/2/25 (T-120 to T-1). FDA decision 11/7/25. Historical price action, not a forecast.
Positioning before the decision
On Dec 5, 2025, 14 days before the decision date, at-the-money options priced a move of ±23.4% through Jan 16, 2026 (the first listed expiry after the decision; ATM implied volatility 88%). The stock closed +0.8% at the first close across the decision and +1.5% 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 date2025-11-07
Outcome✗ CRL⚠ label corrected
Decision-day move-0.2%
T-120 run-up (low→high)+91.0% ($33.23→$63.59)
CRL reasonAficamten (MYQORZO) was FDA-APPROVED Dec 19, 2025; the CRL label on this date appears to be a data error; treat as approved.
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierSmall
Cohort decision-day move (history)3.7% median (n=302)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.
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.