Capricor Therapeutics Inc., a biotechnology firm, has announced a positive outcome from a Type-B Chemistry, Manufacturing and Controls meeting with the FDA. The meeting addressed next steps for the Biologics License Application for their product, CAP-1002, designed for the treatment of Duchenne muscular dystrophy (DMD).
At present, Capricor's shares stand at $5.22, marking an increase of 8.30% from the previous close of 4.82, with a volume of 551,936.
In the course of discussions with the FDA, Capricor was advised to prepare for a pre-Biologics License Application (BLA) meeting and establish a rolling BLA schedule, to be tabled during a subsequent Type-B meeting. In addition to this, the biotech firm has stated its intent to share 3-year safety and efficacy data from its HOPE-2 open-label extension with FDA.
Capricor also shared that data from Cohort B of the HOPE-3 clinical trial will not be necessary for FDA approval of CAP-1002. The firm's product for DMD treatment, CAP-1002, has already received Orphan Drug Designation and its regulatory pathway is supported by the Regenerative Medicine Advanced Therapy Designation.
