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.
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)3.6% median (n=279)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.