Cytokinetics, Incorporated Regulatory Updates and Funding

Cytokinetics, Incorporated filed a Form 8-K on September 15, 2025, detailing regulatory updates and funding activities. The company participated in a Late Cycle Meeting with the FDA regarding its New Drug Application (NDA) for aficamten in obstructive hypertrophic cardiomyopathy (oHCM). Discussions included the proposed REMS program, Elements to Assure Safe Use (ETASU), and anticipated post-marketing requirements. The company expects a differentiated label and risk mitigation profile for aficamten, if approved. The PDUFA target action date remains December 26, 2025. Additionally, the company submitted responses to the European Medicines Agency (EMA) regarding aficamten's potential approval in the European Union. On the funding front, Cytokinetics plans to draw the full $100 million of Tranche 5 term loans under the Development Funding Loan Agreement with Royalty Pharma Development Funding, LLC by October 1, 2025.