Cytokinetics' Aficamten Approval Nears with Q1 2026 US Launch Targeted, FDA Review Advances

Cytokinetics is targeting an early Q1 2026 U.S. launch for aficamten, a treatment for obstructive hypertrophic cardiomyopathy (oHCM), as FDA review advances and clinical milestones approach. The FDA extended the PDUFA date to December 26, 2025, and a late-cycle review meeting has been scheduled. The company's CEO reported that the review is progressing as expected, and the team is working towards a successful launch of the treatment.

Cytokinetics, Incorporated (Nasdaq: CYTK) has reported significant progress in the development and regulatory review of aficamten, a treatment for obstructive hypertrophic cardiomyopathy (oHCM), as the company continues to prepare for a potential U.S. launch in early 2026. The FDA extended the Prescription Drug User Fee Act (PDUFA) target action date to December 26, 2025, and a late-cycle review meeting has been scheduled for September. The company’s CEO, Robert I. Blum, stated that the review is progressing as expected, and the team is focused on a successful launch.

Key highlights from the second quarter of 2025 include positive topline results from the MAPLE-HCM trial, which will be presented at the European Society of Cardiology Congress 2025. Additionally, the company has made substantial progress in its clinical trials for aficamten, including the initiation of the CAMELLIA-HCM trial in Japan. Cytokinetics also announced the approval of ulacamten as the nonproprietary name for CK-4021586 by the World Health Organization.

The company’s financial results for the second quarter of 2025 showed a decrease in cash, cash equivalents, and investments to approximately $1.0 billion, down from $1.1 billion at the beginning of the year. Total revenues for the quarter were $66.8 million, primarily driven by licensing and collaboration agreements and clinical milestone achievements. Research and Development (R&D) expenses increased to $112.6 million, reflecting higher personnel-related costs and medical affairs-related activities. General and Administrative (G&A) expenses also increased to $65.7 million, primarily due to investments toward commercial readiness.

Cytokinetics is maintaining its full-year 2025 financial guidance, with GAAP operating expense projected to be between $670 million and $710 million. The company continues to invest in commercial readiness activities, including sales force recruitment and finalization of promotional launch campaigns, to support the potential approval and launch of aficamten.

References:
[1] https://www.biospace.com/press-releases/cytokinetics-reports-second-quarter-2025-financial-results-and-provides-business-update