Capricor Announces Positive Type-B Interaction With FDA For CAP-1002 In Treating DMD

(RTTNews) - Capricor Therapeutics Inc. (CAPR) Wednesday announced a positive Type-B Chemistry, Manufacturing and Controls meeting with the FDA on next steps for the Biologics License Application for CAP-1002 in treating Duchenne muscular dystrophy or DMD.

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The FDA advised Capricor to include a discussion for a pre-BLA meeting and rolling BLA schedule in the upcoming Type-B meeting. Capricor said it plans to share its HOPE-2 open label extension 3-year safety and efficacy data with FDA.

Data from Cohort B of the HOPE-3 clinical trial will not be necessary for FDA approval of the product.

CAP-1002 for the treatment of DMD has received Orphan Drug Designation and the regulatory pathway for CAP-1002 is supported Regenerative Medicine Advanced Therapy Designation.