Cytokinetics

Cytokinetics announces first dosing in Phase 1 clinical study of CK-089, a fast skeletal muscle troponin activator, targeting muscular dystrophy and impaired muscle function.

S.P. reports research grants and consulting fees from various pharmaceutical companies and organizations. M.C. reports consulting fees and institutional research support from multiple entities and serves on the board of Praxis. B.H. and E.G. report no competing interests.

Cytokinetics updates on cardiac myosin modulation programs, including NDA submission for aficamten, and plans for COMET-HF and AMBER-HFpEF trials, aiming to build a specialty cardiovascular franchise.

Cytokinetics updates on cardiac myosin modulation programs and global commercial launch readiness for aficamten, including NDA submission to FDA in Q3 2024, COMET-HF Phase 3 trial of omecamtiv mecarbil starting Q4 2024, AMBER-HFpEF Phase 2 trial of CK-586 also starting Q4 2024, and preparations for potential aficamten approval and launch in 2025, alongside the launch of the unbranded disease awareness campaign 'HCM Beyond The Heart'.

DelveInsight's report on Congestive Heart Failure Market (2020-2034) covers epidemiology, market trends, key companies, and therapies. Market size was ~USD 6,900 million in 2023, expected to grow significantly. Key companies include Novartis, Bayer, and Eli Lilly. Therapies like ENTRESTO and JARDIANCE are highlighted. Market drivers include aging population and disease prevalence, while barriers include generic therapies and diagnostic challenges.

Cytokinetics launches 'HCM Beyond the Heart' campaign to educate HCPs on hypertrophic cardiomyopathy's personal burdens, featuring patient stories. The campaign aims to support holistic patient care beyond pharmacotherapeutic treatment, with aficamten expected to be FDA-approved and launched by 2025. The campaign's formal launch is rescheduled for the American Heart Association convention in November.

E.C.H.W. and N.N.B., FDA employees, have no conflicts. R.M.C., also an FDA employee, has no conflicts; previously held equity in Verily Life Sciences and Google Health, and served on several boards.

A.A. (UCSF, NIH T32 grant, past consulting income from LeMaitre and MIS Technologies) and D.R. (FDA) have no conflicts of interest. L.H.C. (Duke, FDA, past consulting income from Regeneron, NFLPA, Boehringer, institutional grants from GSK, Novartis) also has no conflicts. R.M.C. (FDA, former Verily Life Sciences, Google Health employee, held equity, served on boards of Cytokinetics, Centessa, Clinetic, Keystone Symposia, C-Path, Clinical Research Forum, One Fifteen) discloses no conflicts related to this manuscript.