Adam Feuerstein , 2025-05-02 11:51:00
Cytokinetics committed an unforced error that has extended the review of its heart disease drug by three months, knocked down its stock price, and once again, triggered the ire of investors over questionable management decision-making.
The Food and Drug Administration “recently notified” Cytokinetics, the company announced Thursday, that the agency required additional time to fully review a safety management plan for its drug aficamten. As a result, the expected approval decision date for the drug was pushed back to Dec. 26 from Sept. 26.
This might have been viewed as a minor disappointment, and perhaps a delay that could have been pinned on staffing cuts at the FDA, except for another aggravating — dare I call it incomprehensible — admission made by Cytokinetics on Thursday.
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