Cytokinetics (CYTK) said Monday it has received acceptance for its new drug application of cardiac myosin inhibitor aficamten from the US Food and Drug Administration to treat obstructive hypertrophic cardiomyopathy.
The decision was based on Cytokinetics' pivotal phase 3 clinical study for 24 weeks of aficamten that demonstrated that the inhibitor showed "significantly improved exercise capacity" compared with placebo, the company said.
The FDA has set Sept. 26, 2025, as the Prescription Drug User Fee Act date, the company said, adding that the FDA has not planned an advisory committee meeting to discuss the application.
Shares of the company were down more than 1% in recent Monday premarket activity.
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