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DEC 19 2025
APPROVED · 224 DAYS AGO

Cytokinetics Myqorzo (aficamten) $CYTK

for obstructive hypertrophic cardiomyopathy (HCM)

NDA · Standard Review

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.

About

Myqorzo (aficamten) is a pill that works by directly calming the overactive heart muscle, reducing its excessive squeezing force. This mechanism targets the fundamental cause of the obstruction and stiffness in symptomatic obstructive HCM. For patients, this may improve their ability to exercise and reduce symptoms like shortness of breath.

Pivotal trial

MAPLE-HCM Phase 3 completed NCT05767346

The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction

Source: ClinicalTrials.gov

Also in development

PDUFA history

  • SEP 26 2025 shifted to DEC 26 2025 (FDA major-amendment extension (3 months) — REMS / risk-mitigation discussions; announced MAY 1 2025)