By Chris Wack


Capricor Therapeutics said Wednesday that it has an upcoming Type-B clinical meeting with the U.S. Food and Drug Administration planned for early in the third quarter.

During the planned meeting with the FDA, Capricor said it will outline its proposed path towards submission of a potential Biologics License Application and further discuss its ongoing clinical trial of CAP-1002 with the agency.

The company plans to use its CAP-1002 for the treatment of Duchenne muscular dystrophy

The regulatory pathway for CAP-1002 is supported by a Regenerative Medicine Advanced Therapy Designation, as well as a Orphan Drug Designation.

If Capricor receives market approval for CAP-1002 by the FDA, it would be eligible to receive a Priority Review Voucher based on its designation as a rare pediatric disease.


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(END) Dow Jones Newswires

June 07, 2023 09:40 ET (13:40 GMT)

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