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Cytokinetics: Aficamten and Ulacamten in Obstructive Hypertrophic Cardiomyopathy Treatment
ByAinvest
Wednesday, Aug 20, 2025 8:06 am ET1min read
Cytokinetics is a cardiology company with a late-stage pipeline, including Aficamten, a therapy for obstructive hypertrophic cardiomyopathy (oHCM). Aficamten has a PDUFA date delayed to December 2025, with an FDA review ongoing. The company also has a second lead candidate, Ulacamten, for heart failure with preserved ejection fraction (HFpEF). Cytokinetics is focused on developing novel therapies for diseases of the heart and muscle.
Cytokinetics, a biopharmaceutical company specializing in heart and muscle diseases, has made significant progress with its late-stage pipeline. One of its lead candidates, Aficamten, has shown promising results in the treatment of obstructive hypertrophic cardiomyopathy (oHCM). The drug is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target date of December 26, 2025 [1].Aficamten is a next-generation cardiac myosin inhibitor that targets a unique myosin binding site. The SEQUOIA-HCM trial demonstrated that Aficamten significantly improved peak oxygen uptake and secondary endpoints in symptomatic oHCM patients [1]. The trial showed no evidence of heart failure risk, although regulatory caution may necessitate a Risk Evaluation and Mitigation Strategy (REMS) [1].
Pharmacists will play a crucial role in patient education, monitoring, and adherence if Aficamten is approved. The drug offers a new hope for HCM patients, enhancing treatment options for those who remain symptomatic despite guideline-directed medical therapy [1].
Cytokinetics is also developing Ulacamten, a therapy for heart failure with preserved ejection fraction (HFpEF), further expanding its pipeline in the cardiology space. The company's focus on developing novel therapies for heart and muscle diseases positions it as a key player in the cardiovascular market.
References:
[1] https://www.pharmacytimes.com/view/fda-officials-near-decision-on-aficamten-for-obstructive-hypertrophic-cardiomyopathy
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