Aficamten

Cytokinetics announced FDA acceptance of its NDA for aficamten, a cardiac myosin inhibitor for obstructive HCM treatment, with a target action date of September 26, 2025. Supported by SEQUOIA-HCM trial results, aficamten showed significant improvements in exercise capacity and symptoms, with a favorable safety profile.

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.

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 in exercise capacity and cardiac function. Aficamten also under evaluation in MAPLE-HCM and FOREST-HCM studies. Bayer AG to acquire rights in Japan, with Cytokinetics receiving upfront and milestone payments.

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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.

Novocure's electrical field-emitting device in Phase 3 trial showed extended survival in pancreatic cancer patients when used with chemo; Merus licensed U.S. rights of its cancer drug zenocutuzumab to Partner Therapeutics; FDA to decide on Cytokinetics' heart drug aficamten approval by Sept. 26, 2025; FDA investigates blood cancer cases post-Bluebird bio's Skysona treatment; Fate Therapeutics' CEO Scott Wolchko to retire, with Bob Valamehr taking over in 2025.

Cytokinetics (CYTK) announced the FDA accepted the New Drug Application for aficamten for obstructive hypertrophic cardiomyopathy, with a PDUFA target action date of September 26, 2025. The FDA previously granted aficamten Orphan Drug and Breakthrough Therapy designations.

The FDA accepted Cytokinetics' NDA for aficamten, a cardiac myosin inhibitor for obstructive HCM, with a PDUFA date of September 26, 2025. Aficamten aims to reduce myocardial hypercontractility and is supported by SEQUOIA-HCM Phase 3 trial data showing significant improvements in exercise capacity and clinical outcomes. The drug has received Orphan Drug and Breakthrough Therapy designations and is under review in China. Cytokinetics anticipates aficamten becoming a preferred HCM treatment and a foundation for its cardiology franchise.