Aficamten

Cytokinetics announced EMA validation of aficamten's MAA for obstructive HCM, supported by SEQUOIA-HCM trial results. The drug, a cardiac myosin inhibitor, aims to improve exercise capacity and relieve HCM symptoms.

Cytokinetics announces Sanofi's acquisition of aficamten rights in Greater China for HCM treatment. Aficamten, a selective cardiac myosin inhibitor, targets myocardial hypercontractility. Cytokinetics eligible for up to $150m in milestone payments and royalties on sales.

Cytokinetics announced EMA validation of aficamten's MAA for obstructive HCM, supported by SEQUOIA-HCM Phase 3 trial results showing significant improvements in exercise capacity. Aficamten has Breakthrough Therapy Designation from FDA and NMPA, with regulatory filings under review in the U.S. and China.

Sanofi acquires exclusive rights to develop and commercialize aficamten, a next-in-class cardiac myosin inhibitor for hypertrophic cardiomyopathy in Greater China from Corxel Pharmaceuticals. Cytokinetics remains eligible for up to $150 million in milestone payments and royalties on future sales. Aficamten has received Breakthrough Therapy Designation for symptomatic obstructive hypertrophic cardiomyopathy and is under various clinical trials.

Cytokinetics announces enrollment open for COMET-HF, a Phase 3 trial evaluating omecamtiv mecarbil for heart failure with severely reduced ejection fraction, in collaboration with Duke Clinical Research Institute.

Cytokinetics announced FDA acceptance of aficamten's NDA for obstructive hypertrophic cardiomyopathy, with a PDUFA date set for Sept. 26, 2025. Aficamten, a cardiac myosin inhibitor, showed improvements in exercise capacity and safety in the SEQUOIA-HCM trial.

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Cytokinetics announced FDA acceptance of NDA for aficamten, a cardiac myosin inhibitor for obstructive hypertrophic cardiomyopathy, with a PDUFA target action date of September 26, 2025. SEQUOIA-HCM Phase 3 trial results showed aficamten significantly improved exercise capacity and clinical outcomes with a favorable safety profile.