Cytokinetics’ Global Strategy Raises Big Questions—Is the Company Ready for a Worldwide HCM Push?

Cytokinetics reported its third quarter 2025 results, highlighting key developments and strategic planning for its lead candidate, aficamten. The company is actively preparing for the potential FDA approval of aficamten for obstructive hypertrophic cardiomyopathy (oHCM), with significant progress in commercial readiness and regulatory engagements. On the regulatory front, Cytokinetics has conducted productive discussions with the FDA regarding aficamten’s Risk Evaluation and Mitigation Strategies (REMS) program and labeling considerations. The completion of Good Clinical Practice (GCP) inspections without noted observations and the ongoing dialogue with the FDA provide a hopeful outlook for the anticipated approval by the end of 2025. Additionally, the company has made strides in seeking approval from the European Medicines Agency (EMA), with ongoing responses to their inquiries and hopes for a favorable decision in the first half of 2026.