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DEC 19 2025
APPROVED · 284 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

Hypertrophic cardiomyopathy is a condition where the heart muscle thickens without a clear cause, making it harder for the heart to pump blood and sometimes disrupting the electrical signals that keep it beating steadily. Myqorzo is a cardiac myosin inhibitor, a pill that binds to the heart's motor protein and dials down how forcefully the muscle contracts. In obstructive HCM, that gentler contraction may ease the outflow blockage and improve symptoms and exercise capacity.

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)