Cytokinetics(CYTK) Newsfilter·2025-01-13 12:30Core Insights - Cytokinetics, Inc. is preparing for the potential approval and commercial launch of aficamten for obstructive hypertrophic cardiomyopathy (HCM) in the U.S. by September 26, 2025, with significant milestones planned for 2025 [1][3][4] - The company has outlined its Vision 2030, aiming to become a leading muscle-focused specialty biopharmaceutical company, with strategic objectives to enhance patient access to innovative medicines [2][10] 2025 Milestones - Aficamten is expected to be commercially launched in the U.S. in the second half of 2025, pending FDA approval [7] - The company plans to continue patient enrollment in the COMET-HF trial for omecamtiv mecarbil through 2025, with completion expected in 2026 [4] - Enrollment for the AMBER-HFpEF trial of CK-586 is set to be completed in the second half of 2025 [5] Clinical Trials and Development - The MAPLE-HCM trial results, comparing aficamten to metoprolol, are anticipated in the first half of 2025 [7] - The ACACIA-HCM trial for aficamten in non-obstructive HCM is expected to complete enrollment in the second half of 2025 [7] - The CEDAR-HCM trial for pediatric patients is also set to complete enrollment in the second half of 2025 [7] Vision 2030 Objectives - The Vision 2030 roadmap includes goals to deliver product approvals, achieve broad access to medicines, and promote equitable access [10][14] - The company aims to reach over 100,000 patients globally with its medicines and extend its leadership in muscle biology through multiple therapeutic modalities [14]