Capricor Receives FDA Regenerative Medicine Advanced Therapy Designation for Duchenne Muscular Dystrophy Therapy

Biotech Investing

Capricor Therapeutics (NASDAQ:CAPR) today announced that the U.S. Food and Drug Administration has granted CAP-1002, its lead investigational cell therapy for the treatment of Duchenne muscular dystrophy, the Regenerative Medicine Advanced Therapy designation. As quoted in the press release: In notifying Capricor, the FDA Office of Tissues and Advanced Therapies, stated that the FDA will “work …

As quoted in the press release:

In notifying Capricor, the FDA Office of Tissues and Advanced Therapies, stated that the FDA will “work closely” with Capricor “to provide guidance on the subsequent development of CAP-1002” for the treatment of Duchenne muscular dystrophy, “including providing advice on generating the evidence needed to support approval of the drug in an efficient manner.”

Click here to read the full press release.

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