Biotechnology company Capricor Therapeutics (NASDAQ:CAPR) announced on Wednesday that it has begun the rolling submission process for a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) to seek full approval for deramiocel in treating Duchenne muscular dystrophy (DMD) cardiomyopathy.

This represents a significant advancement in the regulatory pathway for deramiocel, a first-in-class therapy aimed at addressing a critical unmet medical need. Capricor aims to finalize the BLA submission by the end of 2024.

Priority review may be granted due to deramiocel's potential to offer meaningful improvements in safety and efficacy for DMD cardiomyopathy, a condition with no approved treatments. Upon completion, the FDA will notify Capricor when the application is formally accepted for review.