Cytokinetics, Inc.
Cytokinetics Participates in Late Cycle Meeting with FDA for Aficamten NDA
Summary
On September 15, 2025, Cytokinetics, Incorporated participated in a Late Cycle Meeting with the FDA regarding its New Drug Application (NDA) for aficamten in obstructive hypertrophic cardiomyopathy (oHCM). The Company discussed its proposed REMS program, including Elements to Assure Safe Use (ETASU) and anticipated post-marketing requirements. Cytokinetics continues to expect a differentiated label and risk mitigation profile for aficamten if approved by the FDA. The Prescription Drug User Fee Act (PDUFA) target action date for the NDA remains December 26, 2025.
Profitelligence Alerts
Get alerts for CYTK
Be first to know when Cytokinetics, Inc. files with the SEC.
Filing Categories
Advertisement
About Cytokinetics, Inc.
Cytokinetics, Inc. is a biopharmaceutical company focused on the discovery, development, and commercialization of novel muscle activators as potential treatments for debilitating diseases. Primarily, the company's work aims to address unmet medical needs in the fields of neurology and cardiology, offering therapeutic solutions that target muscle function. Cytokinetics' research centers on small molecule drugs that modulate muscle performance, which could significantly aid patients suffering from heart failure, amyotrophic lateral sclerosis (ALS), and other muscle-related conditions. The company is actively involved in clinical trials and collaborates with other notable entities in its quest for innovative medical advancements. Its contributions to the healthcare sector exemplify the growing role of targeted therapy in improving patient outcomes. Headquartered in South San Francisco, California, Cytokinetics operates as a key player in the biotechnology landscape, with a commitment to pioneering treatments that leverage the complex mechanisms of muscle biology.
Official SEC Documents
Advertisement