for obstructive hypertrophic cardiomyopathy (HCM)
FDA approved Myqorzo (aficamten) on December 19, 2025 — ~1 week ahead of the extended PDUFA — for adults with symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms. Second-in-class cardiac myosin inhibitor after BMS's Camzyos (mavacamten). Available in 5/10/15/20 mg doses.
Hypertrophic cardiomyopathy thickens the heart muscle, making it harder to pump blood and sometimes disrupting electrical signals that coordinate heartbeats. Myqorzo (aficamten) is a pill that directly targets overactive heart muscle fibers by blocking a key protein involved in excessive contraction. By calming this overdrive, the drug may help relieve symptoms like shortness of breath and improve daily activity levels for people with this condition.
This is an open-label extension study of China cohort in the phase 3 study (CY 6031) of aficamten for the treatment of obstructive HCM (oHCM) to collect long-term safety and tolerability data, including assessments of cardiac function and steady-state Pharmacokinetics (PK) during chronic dosing with aficamten.
Source: ClinicalTrials.gov