Form 8-K CAPRICOR THERAPEUTICS, For: Feb 05
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Capricor (CAPR) Receives FDA RMAT Designation for Duchenne Muscular Dystrophy Therapy
February 5, 2018 7:09 AM ESTCapricor Therapeutics (NASDAQ: CAPR) today announced that the U.S. Food and Drug Administration (FDA) has granted CAP-1002, its lead investigational cell therapy for the treatment of Duchenne muscular dystrophy, the Regenerative Medicine Advanced Therapy (RMAT) designation.
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.
The FDA... More
