Cytokinetics Announces 2025 Corporate Milestones and Vision 2030

Core Insights - Cytokinetics, Inc. is preparing for a pivotal year in 2025 with a focus on the potential approval and commercial launch of aficamten for obstructive hypertrophic cardiomyopathy (HCM) in the U.S. [2] - The company has outlined its Vision 2030, aiming to become a leading muscle biology specialty biopharmaceutical company by delivering innovative medicines and improving patient lives globally [8]. 2025 Milestones - Aficamten, a cardiac myosin inhibitor, is set for potential approval and commercial launch in the U.S. in the second half of 2025, pending FDA approval [4]. - The company is advancing clinical trials for aficamten, including the MAPLE-HCM trial, with topline results expected in the first half of 2025 [4][3]. - Enrollment in the COMET-HF trial for omecamtiv mecarbil will continue through 2025, with completion expected in 2026 [3]. Commercial Strategy - Cytokinetics is preparing go-to-market strategies for aficamten in the U.S. and expanding commercial readiness in Europe, anticipating EMA approval in the first half of 2026 [4]. - Coordination with Sanofi is planned to support aficamten's potential approval in China in the second half of 2025 [4]. Ongoing Research and Development - The company is also focused on completing the Phase 1 study of CK-089, a fast skeletal muscle troponin activator, in healthy participants in 2025 [6]. - Ongoing pre-clinical development and research activities are directed towards additional muscle biology-focused programs [7]. Vision 2030 Objectives - The Vision 2030 roadmap includes goals to deliver product approvals, achieve broad access to medicines, and promote equitable access [8][11]. - The company aims to reach over 100,000 patients globally with its medicines and extend its leadership in muscle biology through multiple therapeutic modalities [11].