Cytokinetics has commenced U.S. commercial operations for MYQORZO (aficamten) following December 2025 FDA approval for symptomatic obstructive hypertrophic cardiomyopathy, with initial prescriptions already dispensed to patients. The cardiac-focused biopharmaceutical company has simultaneously secured regulatory clearance from China's NMPA and the European Commission, establishing a multi-market foundation for the newly approved therapeutic.
The company reported a cash and investment position of $1.22 billion as of December 31, 2025, supporting planned expansion activities throughout 2026. Cytokinetics has provided full-year guidance of $830 million to $870 million in combined research and development and selling, general, and administrative expenses, reflecting investments in commercial execution and continued clinical development.
Key milestones anticipated in the coming months include topline efficacy and safety data from the ACACIA-HCM trial expected in the second quarter of 2026, along with a planned commercial launch in Germany during the same period. These developments position the company to evaluate MYQORZO's market penetration while advancing its clinical pipeline in a target indication with limited treatment options.