Capricor Therapy FDA Review Extended

FDA Extends Review for Capricor Duchenne Therapy Following New Data

Capricor Therapeutics, Inc. (NASDAQ:CAPR) has received a three-month extension to review its experimental cell therapy for Duchenne muscular dystrophy. The FDA accepted new 24-month clinical data and additional analyses from the company, which supports a refined proposed indication focused on upper limb function, a primary goal of Capricor's late-stage trial. This shift from the previous attempt to secure approval for cardiomyopathy in Duchennes patients, which was rejected by the FDA last year. However, the extension gives regulators more time to consider the new evidence, but could potentially delay a decision until November 22. The revised strategy may give Capricors a more focused regulatory argument regarding deramiocel's effect on Duchenene-related heart disease.

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