Aficamten

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.

Cytokinetics announced EMA validation of aficamten's MAA for obstructive HCM, supported by SEQUOIA-HCM trial results. The MAA follows FDA's NDA acceptance with a PDUFA date of Sept 26, 2025. Aficamten, a cardiac myosin inhibitor, showed significant improvements in exercise capacity and secondary endpoints in Phase 3 trials.

Cytokinetics' aficamten, a cardiac myosin inhibitor for obstructive hypertrophic cardiomyopathy (HCM), has its Marketing Authorization Application (MAA) validated by EMA, advancing its review process in Europe, following ongoing reviews 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.

Sanofi acquires rights to develop and commercialize aficamten in Greater China for HCM treatment from CORXEL. Cytokinetics to receive up to $150M in milestone payments and royalties. Aficamten, a cardiac myosin inhibitor, has Breakthrough Therapy Designation and is under Phase 3 trials for HCM.

Sanofi acquires exclusive rights to aficamten, a cardiac myosin inhibitor for hypertrophic cardiomyopathy treatment in Greater China, from Corxel Pharmaceuticals. Cytokinetics to receive up to $150M in milestone payments and royalties, leveraging Sanofi's cardiovascular expertise for broader patient access.

Sanofi acquires rights to develop and commercialize aficamten, a cardiac myosin inhibitor for hypertrophic cardiomyopathy (HCM) treatment in Greater China from CORXEL. Cytokinetics, the original rights holder, may receive up to $150M in milestone payments and royalties. Aficamten, with Breakthrough Therapy Designation, is under clinical trials for HCM treatment.

Cytokinetics' NDA for aficamten, a cardiac myosin inhibitor for obstructive HCM, accepted by FDA with a target action date of Sept. 26, 2025. Supported by phase III SEQUOIA-HCM study showing significant improvements. Bayer AG to acquire rights in Japan, with Cytokinetics receiving payments and royalties. CYTK shares down 39.5% YTD.