Aficamten

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.

Cytokinetics announced FDA's acceptance of aficamten's NDA for obstructive HCM treatment, with a PDUFA target action date of September 26, 2025. Aficamten, a cardiac myosin inhibitor, showed significant improvements in SEQUOIA-HCM trial, enhancing exercise capacity and symptoms in HCM patients with a favorable safety profile.

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

Cytokinetics announced FDA acceptance of its NDA for aficamten, targeting obstructive HCM treatment, with a PDUFA action date of September 26, 2025. Aficamten showed significant improvements in exercise capacity and symptoms in the SEQUOIA-HCM trial, with a favorable safety profile. The drug aims to become a preferred treatment for HCM, supported by its Breakthrough Therapy and Orphan Drug 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.

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.

The article discusses the importance of enabling JavaScript for optimal app performance.