Aficamten

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.

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 trial results showed significant improvements in exercise capacity and favorable safety profile.

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.

Cytokinetics announced FDA acceptance of its NDA for aficamten, a cardiac myosin inhibitor for treating obstructive hypertrophic cardiomyopathy (HCM), with a PDUFA target date of September 26, 2025. The NDA is supported by SEQUOIA-HCM Phase 3 trial results showing significant exercise capacity improvement with aficamten versus placebo, and positive impacts on clinical outcomes and cardiac biomarkers.

Aficamten treatment in FOREST-HCM trial showed 70% of SRT-eligible oHCM patients no longer needing SRT after 24 weeks, with 92.9% improving at least 1 NYHA class.

Astellas' request to update Izervay's prescribing info rejected by FDA; Jupiter Bioventures, co-founded by Norman Sharpless and Nathaniel David, launches with $70M to create biotech startups; Bayer pays Cytokinetics $53M for aficamten licensing in Japan; Neurogene continues Rett syndrome gene therapy trial at lowest dose after side effects; Cybin's stock dips despite positive Phase 2 data for CYB003; Novartis licenses radiopharmaceutical from Ratio Therapeutics, targeting SSTR2 protein.

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Cytokinetics and Bayer form exclusive licensing deal for aficamten in Japan, focusing on hypertrophic cardiomyopathy (HCM). The agreement includes €50 million upfront, potential €90 million in milestones, and up to €490 million in commercial milestone payments, plus tiered royalties on Japanese sales. Bayer will conduct Phase 3 trials for obstructive HCM, while Cytokinetics expands ACACIA-HCM and CEDAR-HCM trials into Japan.

Cytokinetics presented new post-hoc analyses of GALACTIC-HF, showing omecamtiv mecarbil's efficacy in reducing heart failure risks in high-risk patients, including older adults and those with ventricular arrhythmias. The treatment effect was consistent across age groups and reduced the primary outcome risk in severe heart failure patients. Omecamtiv mecarbil also showed safety regarding ventricular arrhythmias and potential benefits for those with severely reduced LVEF.