Shots:
- Cytokinetics has reported P-III (MAPLE-HCM) trial data assessing aficamten vs SoC metoprolol in pts (n=175) with symptomatic obstructive hypertrophic cardiomyopathy (HCM); regulatory review is ongoing in the US FDA (PDUFA: Dec 26, 2025) & EMA, with its NDA also under NMPA’s priority review
- The trial met its 1EP, showing superior improvement in peak oxygen uptake (pVO₂) from baseline to Wk. 24 as measured by cardiopulmonary exercise testing; full data to be presented in a future meeting
- Additionally, aficamten is being evaluated in multiple P-III trials, incl. ACACIA-HCM for non-obstructive HCM, CEDAR-HCM pediatric trial for obstructive HCM, & FOREST-HCM OLE study in HCM pts
Ref: Cytokinetics | Image: Cytokinetics | Press Release
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