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.

Currently, the shares are at $5.22, up 8.30 percent from the previous close of 4.82, on a volume of 551,936.

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.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


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