Capricor Therapeutics, a biotechnology firm, announced on Thursday that it has completed the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). This application seeks full approval for deramiocel, an investigational cell therapy aimed at treating patients with Duchenne muscular dystrophy (DMD) cardiomyopathy.
Linda Marban, CEO of Capricor, commented on the milestone, stating, "Submitting the BLA is a significant advancement for Capricor and those affected by DMD. This BLA represents extensive efforts to deliver a potentially groundbreaking therapy to patients in need. We believe deramiocel's application is robust due to its demonstrated ability in multiple clinical trials to mitigate cardiac issues associated with DMD. We are eager to collaborate with the FDA throughout the review process to facilitate a potential approval."
The company completed the full rolling BLA submission as previously indicated in late December 2024. This effort is supported by Capricor's existing cardiac data from its Phase 2 HOPE-2 and HOPE-2 Open Label Extension (OLE) trials, supplemented by natural history data from an FDA-funded and published dataset regarding the ramifications of DMD cardiomyopathy and potential disease progression biomarkers.
Capricor has also requested a priority review from the FDA. If granted, this would expedite the review timeline from the standard 10-month period to a shorter 6-month priority review, starting from the date of the FDA's acceptance of the submission.
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