Cytokinetics wins UK MHRA approval and NICE backing for MYQORZO (aficamten) in obstructive HCM

On 30 July 2026, Cytokinetics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for MYQORZO (aficamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The company also secured positive final draft guidance from the National Institute for Health and Care Excellence (NICE), recommending the drug for use on the NHS in England and Wales.

Aficamten is a next-in-class cardiac myosin inhibitor designed to reduce the excessive cardiac contractility that drives left ventricular outflow tract obstruction in HCM. The approval was supported by the pivotal Phase 3 SEQUOIA-HCM trial, in which aficamten improved peak oxygen uptake and functional capacity in patients with symptomatic obstructive HCM.

The dual MHRA authorisation and NICE recommendation clear the path for reimbursed NHS access, marking a significant regulatory milestone for Cytokinetics as it builds out the commercial footprint of its lead cardiovascular medicine beyond the United States.