Cytokinetics Inc., trumpeted US FDA approval for Myqorzo (aficamten) tablets (5 mg, 10 mg, 15 mg, and 20 mg strengths) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. The approval marks Cytokinetics’ first FDA-approved medicine and is based on positive results from the pivotal SEQUOIA-HCM Phase 3 trial.
Myqorzo is an allosteric and reversible cardiac myosin inhibitor that directly targets hypercontractility and left ventricular outflow tract (LVOT) obstruction in oHCM patients. In SEQUOIA-HCM, treatment demonstrated significant improvements in exercise capacity and symptom relief versus placebo, consistent across key patient subgroups.
The label includes a Boxed Warning for heart failure risk due to reduced left ventricular ejection fraction (LVEF), and the product will be available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) requiring echocardiographic monitoring before and during treatment. Myqorzo is expected to launch in the US in January 2026, supported by the company’s patient-education and insurance assistance initiative.
Myqorzo is the second FDA-approved therapy in the oHCM space, entering a market previously dominated by Bristol Myers Squibb’s Camzyos (mavacamten) and offering a potentially more convenient dosing and safety profile. Aficamten may offer a faster onset of action compared to mavacamten thanks to a shorter half-life and more rapid achievement of steady-state concentrations, allowing for quicker titration and effect on cardiac contractility. The molecule’s pharmacokinetics also allow for easier and more frequent dose adjustments, useful in clinical practice for individualized therapy.
In parallel, China’s NMPA recently approved Myqorzo for oHCM, and the EU’s CHMP has issued a positive opinion with a final European Commission decision expected in Q1 2026, underscoring a rapidly evolving global regulatory landscape for the medicine. Of note, Cytokinetics has signed several regional licensing deals in relation to Myqorzo, with Bayer (for Japan) and Sanofi (for Greater China), as well as a substantial royalty funding collaboration with Royalty Pharma.