Capricor completes BLA submission for deramiocel

US biotech Capricor Therapeutics (Nasdaq: CAPR) today announced the completion of the submission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking full approval for deramiocel, an investigational cell therapy, to treat patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy.

The company noted that the submission of the BLA marks a pivotal step for Capricor and those impacted by DMD.

“This BLA is the culmination of a body of work that has been focused on bringing this potentially transformational therapy to those patients in need," said Linda Marbán, chief executive of Capricor. “We believe that the strength of this application is that deramiocel has shown in multiple clinical trials attenuation of the cardiac implications of DMD. We look forward to working with the FDA throughout the review process to support this potential approval,” she added.