Cytokinetics, Inc. (NASDAQ: CYTK) announced that the U.S. Food and Drug Administration approved its cardiac myosin inhibitor MYQORZO (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The approval, granted on December 19, 2025, marks the company’s first FDA‑approved product and validates its muscle‑modulator platform.
The approval was based on the Phase 3 SEQUOIA‑HCM trial, which enrolled 282 patients and demonstrated that MYQORZO significantly improved exercise capacity—measured by peak oxygen uptake—and reduced left‑ventricular outflow‑tract (LVOT) gradients compared with placebo. The trial’s results support the drug’s mechanism of action as a reversible cardiac myosin inhibitor that lowers hypercontractility in the heart.
MYQORZO carries a boxed warning for the risk of heart failure due to potential reductions in left‑ventricular ejection fraction. The labeling includes a Risk Evaluation and Mitigation Strategy (REMS) that requires regular echocardiographic monitoring to manage this risk. The REMS program is designed to ensure patient safety while allowing broader access to the therapy.
Cytokinetics plans to launch MYQORZO in the United States in the second half of January 2026 and will offer a patient support program called MYQORZO & You™. The company also received approval from the China National Medical Products Administration on December 17, 2025, and expects a European Commission decision in the first quarter of 2026, positioning the drug for a global rollout.
Analysts have upgraded their coverage of Cytokinetics to “Strong Buy,” citing the FDA approval as a pivotal milestone that unlocks a new revenue stream and strengthens the company’s pipeline. The approval has also prompted a surge in analyst optimism, with many upgrading their outlooks and raising their expectations for the company’s commercial performance.
CEO Robert I. Blum said, “This FDA approval is a historic moment for Cytokinetics and for patients with obstructive HCM. It confirms the promise of our science and sets the stage for the first commercial launch of a muscle‑modulator therapy.” He added that the company remains focused on scaling production, securing reimbursement, and expanding access through its patient support program.
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