Shots:
- The CHMP has recommended Cytokinetics’ Myqorzo for the treatment of adults with symptomatic (NYHA, class II-III) oHCM, with EC decision expected in Q1’26
- Opinion was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.8 vs 0 ml/kg/min, consistent across all subgroups & in pts with or without background beta-blocker therapy. Results were published in The NEJM
- Additionally, Myqorzo is under regulatory review in other countries, incl. the US (PDUFA: Dec 26, 2025), while China’s NMPA is reviewing its NDA under Priority Review
Ref: Cytokinetics| Image: Cytokinetics |Press Release
Related News: Cytokinetics Reports P-III (MAPLE-HCM) Trial Data of Aficamten for Obstructive Hypertrophic Cardiomyopathy
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