Cytokinetics Highlights Progress in Cardiac Myosin Modulation Programs and Global Commercial Launch Readiness at Investor & Analyst Day

Core Insights - Cytokinetics has submitted a New Drug Application (NDA) for aficamten to the FDA and is preparing for a potential commercial launch in 2025 [2][8] - The company is advancing its cardiac myosin modulation programs, including the COMET-HF Phase 3 trial for omecamtiv mecarbil and the AMBER-HFpEF Phase 2 trial for CK-586, both expected to begin in Q4 2024 [1][5][6] Company Developments - The NDA submission for aficamten marks a significant step in the company's strategy to build a specialty cardiovascular franchise [2] - Cytokinetics is focusing on differentiated market access and patient experience as part of its go-to-market strategies for aficamten [8] - The company has launched an unbranded disease awareness campaign titled "HCM Beyond The Heart" aimed at healthcare professionals [1][8] Clinical Trials - COMET-HF is a Phase 3 trial designed to assess the efficacy and safety of omecamtiv mecarbil in patients with symptomatic heart failure and severely reduced ejection fraction, with an expected enrollment of approximately 1,800 patients [3][5] - AMBER-HFpEF is a Phase 2 trial aimed at evaluating the safety and tolerability of CK-586 in patients with symptomatic heart failure with preserved ejection fraction, also set to begin in Q4 2024 [6][18] Expert Perspectives - The event will feature insights from leading clinicians specializing in hypertrophic cardiomyopathy (HCM) and heart failure, enhancing the understanding of treatment landscapes [7] Global Launch Preparations - Cytokinetics is actively engaging with payers and conducting health economics research to support the launch of aficamten in the U.S. and Europe [8][10] - The company plans to submit a Marketing Authorization Application (MAA) for aficamten to the European Medicines Agency (EMA) in Q4 2024 [10]