Cytokinetics Shares Fall After FDA Extends Review of Heart Drug Aficamten

Dow Jones

May 02, 2025

By Stephen Nakrosis

Shares of biopharmaceutical company Cytokinetics were trading in the red in the after-hours market following news the Food and Drug Administration extended the prescription drug user fee act action date for the new drug application for aficamten.

The company is evaluating aficamten to treat patients with obstructive hypertrophic cardiomyopathy, a thickening of the heart muscle.

The FDA said it needed additional time to conduct a full review of the company's proposed risk evaluation and mitigation strategy, Cytokinetics said. No additional clinical data or studies have been requested by the FDA, the company also said.

After the bell, the company's shares were trading 13% lower, at $37.10. The stock closed Thursday's regular session at $42.92, basically flat on the day.

Year to date, the stock is down by over 33%.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

May 01, 2025 18:45 ET (22:45 GMT)

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