Cytokinetics Secures FDA Approval for MYQORZO (aficamten) to Treat Symptomatic Obstructive Hypertrophic Cardiomyopathy
Summary
Cytokinetics, Inc. announced the U.S. Food and Drug Administration (FDA) approval of MYQORZO (aficamten), a cardiac myosin inhibitor, for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). This approval is a major milestone, directly addressing the underlying hypercontractility associated with obstructive HCM to improve patients' functional capacity and symptoms. The drug, which is also approved in China and is under regulatory review in the European Union, underscores the global commercial potential, particularly through its collaboration agreement with Sanofi, which holds exclusive rights in Greater China.
Cytokinetics received FDA approval for MYQORZO (aficamten) on December 19, 2025. The drug treats symptomatic obstructive hypertrophic cardiomyopathy in adults. This milestone validates Cytokinetics' pipeline and boosts its global commercial outlook.
Key Takeaways
- MYQORZO is a Cardiac Myosin Inhibitor for obstructive HCM.
- Sanofi holds exclusive rights for commercialization in Greater China.
- European marketing authorization is anticipated in the first quarter of 2026.
Sentiment: Bullish
The FDA approval and global regulatory progress significantly de-risk the asset for Cytokinetics.
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