FDA Approves Cytokinetics’ Myqorzo for Obstructive Hypertrophic Cardiomyopathy, Positioning It Against BMS’s Camzyos

The FDA approved Cytokinetics' Myqorzo (aficamten) on Friday for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms in Class II or III patients.12

Myqorzo features less restrictive risk mitigation than BMS's Camzyos, including more flexible dosing, less frequent echocardiograms, and minimal drug interaction monitoring, potentially easing prescribing.1

This marks Cytokinetics' first U.S. product approval after nearly 30 years, with the drug available in the second half of January at a list price similar to Camzyos ($89,500 annually).1

Myqorzo was also approved in China by the NMPA early last week.13

Analysts see Myqorzo as a competitive threat to Camzyos, expected to exceed $1B in sales, with upcoming data on non-obstructive HCM potentially broadening its lead.1

Sources:

1. https://www.biopharmadive.com/news/cytokinetics-myqorzo-fda-approval-obstructive-hypertrophic-cardiomyopathy-camzyos/808456/

2. https://ir.cytokinetics.com/press-releases/press-release-details/2025/Cytokinetics-Announces-FDA-Approval-of-MYQORZO-aficamten-for-the-Treatment-of-Adults-with-Symptomatic-Obstructive-Hypertrophic-Cardiomyopathy-to-Improve-Functional-Capacity-and-Symptoms/default.aspx

3. https://ir.cytokinetics.com/press-releases/press-release-details/2025/Cytokinetics-Announces-NMPA-Approval-of-MYQORZO-aficamten-in-China--for-Patients-with-Obstructive-Hypertrophic-Cardiomyopathy/default.aspx