Cytokinetics vs. Camzyos: Who Will Win the Battle for HCM Patients?

Cytokinetics presented its Q2 2025 earnings and strategic updates, which highlighted significant operational milestones and challenges. The company’s focus remains on advancing its pipeline of muscle biology-focused therapies, particularly within cardiology. A key development is the ongoing regulatory process for aficamten, a treatment for obstructive hypertrophic cardiomyopathy (oHCM). The FDA extended its PDUFA date for the New Drug Application to December 26, 2025. Regulatory reviews in Europe and China are progressing, with potential approvals anticipated in the first half of 2026 in Europe, and in the second half of this year in China. Interaction with regulatory bodies has shown no major obstacles, indicated by completed GCP inspections without observations.