Cytokinetics Gets FDA Breakthrough Designation for Aficamten
10 December 2021 - 12:15AM
Dow Jones News
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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