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Cytokinetics Reports First Quarter 2025 Financial Results and Provides Business Update
PDUFA Date for Aficamten in Obstructive HCM Extended by FDA to December 26, 2025 Topline Results from MAPLE-HCM Expected in May Enrollment Completed in
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"PDUFA Date for Aficamten in Obstructive HCM Extended by FDA to December 26, 2025 Topline Results from MAPLE-HCM Expected in May Enrollment Completed in ACACIA-HCM; Topline Results Expected in 1H 2026 ~$1.1 Billion in Cash, Cash Equivalents and Investments as of March 31, 2025 SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the first quarter of 2025. “In the first quarter, we made progress towards commercial readiness and advanced our specialty cardiology pipeline,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Recently, our PDUFA date for aficamten in obstructive HCM was extended by FDA to provide time to review a REMS submission made at the Agency’s request subsequent to the initial NDA filing acceptance. We remain confident in the distinct benefit-risk and pharmaceutic profile of aficamten, and our top priority is bringing this potential therapy to patients. This month, we also expect to report topline results from MAPLE-HCM, and we continue conduct of ACACIA-HCM, for which we have now completed enrollment of patients. With a strong balance sheet and prudent attention to capital deployment, we are well positioned to deliver across regulatory, clinical and commercial milestones.” Q1 and Recent Highlights Cardiac Muscle Programs aficamten (cardiac myosin inhibitor) The U.S. Food & Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) target action date for the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) to December 26, 2025. Following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for aficamten in obstructive HCM without an accompanying REMS and the FDA accepted the NDA for filing. During the NDA review, the FDA requested that Cytokinetics submit a REMS consistent with the inherent characteristics of aficamten, which the company provided. The submission of a REMS has now been determined by FDA to be a Major Amendment to the NDA resulting in a standard three-month extension to the original PDUFA action date. No additional clinical data or studies have been requested of Cytokinetics by FDA. Completed a mid-cycle review meeting wi...