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FDA Approves Myqorzo for Obstructive Hypertrophic Cardiomyopathy

12/20/2025

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Summary

Cytokinetics' Drug Approved

The U.S. Food and Drug Administration approved Cytokinetics' drug Myqorzo for obstructive hypertrophic cardiomyopathy.
Myqorzo is a cardiac myosin inhibitor that targets cardiac muscle contraction.
Myqorzo will be available in January for patients with obstructive hypertrophic cardiomyopathy.
The labeling includes a serious warning for heart failure risks.
Cytokinetics' shares rose in after-hours trading after the approval.

Summary

Cytokinetics Seeks Approval

Cytokinetics expects U.S. FDA approval of aficamten for obstructive hypertrophic cardiomyopathy (oHCM) on December 26.
The approval would be Cytokinetics’ first FDA approval after 27 years.
Analysts project aficamten could reach about $10 billion in annual sales.
Aficamten’s rapid titration offers an advantage over Bristol Myers Squibb's Camzyos, which has slower dosing, and Cytokinetics plans global commercialization partnerships.

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Cytokinetics' Drug Approved

The U.S. Food and Drug Administration approved Cytokinetics' drug Myqorzo for obstructive hypertrophic cardiomyopathy.
Myqorzo is a cardiac myosin inhibitor that targets cardiac muscle contraction.
Myqorzo will be available in January for patients with obstructive hypertrophic cardiomyopathy.
The labeling includes a serious warning for heart failure risks.
Cytokinetics' shares rose in after-hours trading after the approval.

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