CYTK FDA Decision CRL · 2025-11-07

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)

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

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.