Cytokinetics(US:CYTK) Globenewswire·2025-12-12 13:42Core Insights - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for MYQORZO® (aficamten) for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults, with a final decision expected from the European Commission in Q1 2026 [2][3]. Company Overview - Cytokinetics is a biopharmaceutical company focused on developing treatments for cardiac muscle dysfunction, with over 25 years of experience in muscle biology [15]. - The company is preparing for potential regulatory approvals and commercialization of aficamten following positive results from the pivotal Phase 3 clinical trial SEQUOIA-HCM [15]. Clinical Trial Results - The CHMP recommendation is based on the SEQUOIA-HCM trial, which demonstrated significant improvements in exercise capacity and safety for patients treated with MYQORZO compared to placebo [5][6]. - MYQORZO treatment for 24 weeks resulted in a peak oxygen uptake (pVO2) increase of 1.8 ml/kg/min compared to a 0.0 ml/kg/min change in the placebo group, with a statistically significant difference (p=0.000002) [6]. - The treatment was well-tolerated, with serious adverse events occurring in 5.6% of MYQORZO patients versus 9.3% in the placebo group [7]. Drug Mechanism and Development - Aficamten is a selective cardiac myosin inhibitor designed to reduce myocardial hypercontractility associated with hypertrophic cardiomyopathy (HCM) by binding to cardiac myosin [8]. - The drug has received Breakthrough Therapy Designation from the FDA and the NMPA in China for treating symptomatic HCM [10]. Ongoing Research - Aficamten is also being evaluated in additional clinical trials, including ACACIA-HCM for non-obstructive HCM and CEDAR-HCM for pediatric patients with oHCM [11].