Cytokinetics Gets FDA Breakthrough Designation for Aficamten

By Colin Kellaher

Cytokinetics Inc. on Thursday said the U.S. Food and Drug Administration granted breakthrough-therapy designation to aficamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy, a disease in which the heart muscle becomes abnormally thick.

The South San Francisco, Calif., biopharmaceutical company said the designation for aficamten is based on results from a Phase 2 study in which a large majority of patients treated with the cardiac myosin inhibitor achieved the target goal of treatment.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

Shares of Cytokinetics, which closed Wednesday at $37.05, rose about 4% in light premarket trading Thursday.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

December 09, 2021 08:00 ET (13:00 GMT)

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