Cytokinetics Reports Third Quarter 2025 Financial Results and Provides Business Update

Interactions with FDA Progressing Towards December 26, 2025 PDUFA Date for Aficamten; U.S. Commercial Launch Preparations on Track

Ex-U.S. Regulatory Reviews of Aficamten Ongoing in China and E.U.

~$1.25 Billion in Cash, Cash Equivalents and Investments as of September 30, 2025

SOUTH SAN FRANCISCO, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the third quarter of 2025.

“I’m pleased that our teams continue to demonstrate strong execution and sustained momentum as we approach the PDUFA date for the aficamten NDA. Our commercial preparations have been deliberate and strategic, positioning us well for this milestone,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “During the third quarter, we expanded the evidence base for aficamten, with MAPLE-HCM further reinforcing the potential of aficamten in patients with obstructive HCM. With a strong balance sheet, clear focus, and a deep commitment to our mission, we are entering this pivotal transformation toward potential commercialization with confidence, alignment and purpose as we aim to deliver on the promise of translating our science to a new medicine for patients.”

Q3 and Recent Highlights

Cardiac Muscle Programs

aficamten (cardiac myosin inhibitor)

• Continued to support the review of the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) by the U.S. Food and Drug Administration (FDA) ahead of the Prescription Drug User Fee Act (PDUFA) action date of December 26, 2025.
• On September 15, 2025, the Company participated in a Late Cycle Meeting with the FDA regarding the NDA for aficamten in which the Company discussed its proposed Risk Evaluation and Mitigation Strategy (REMS) program, including Elements to Assure Safe Use (ETASU) and anticipated post-marketing requirements. Based on the Company’s discussions and communications with FDA to date, the Company continues to expect a differentiated label and risk mitigation profile for aficamten, if approved by the FDA.
• Submitted responses to the Day 120 List of Questions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) with respect to the ongoing review of the Marketing Authorization Application (MAA) for aficamten for the treatment of obstructive HCM in the European Union and received the Day 180 List of Questions. We expect a potential EMA decision regarding the MAA in 1H 2026.
• Continued to support the review of the NDA for aficamten for obstructive HCM by the Center for Drug Evaluation (CDE) in China.
• Presented primary results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), a Phase 3 randomized, double-blind, active-comparator clinical trial, at the European Society of Cardiology Congress 2025 demonstrating superiority of aficamten to metoprolol on peak oxygen uptake (pVO2) (change from baseline to Week 24, least squares mean (LSM) treatment difference (SE), +2.3 (0.39) mL/kg/min, p