Capricor Therapeutics Initiates FDA Rolling Submission for Duchenne Muscular Dystrophy Treatment

On October 9, 2024, Capricor Therapeutics, Inc. (NASDAQ: CAPR) made a significant announcement regarding its progress with the U.S. Food and Drug Administration (FDA). The company revealed that it has commenced the rolling submission process for a Biologics License Application (BLA) for deramiocel, a treatment intended for all patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy.

In a press release issued by Capricor, it was disclosed that the submission process aims to secure full approval for deramiocel, a hopeful development in the treatment of DMD cardiomyopathy. The filing signifies a pivotal step for Capricor in its pursuit of providing effective solutions for patients grappling with this condition.

The company’s strategic move is geared towards fulfilling its regulatory obligations and expanding its reach in the field of muscular dystrophy treatments. Capricor has outlined its intent to finalize the rolling BLA submission by the conclusion of 2024, highlighting a targeted timeline for this critical regulatory undertaking.

Furthermore, Capricor indicated that the information presented in the press release and associated documents are intended as a disclosure under Regulation FD and are not to be construed as a filed document under the Securities Exchange Act of 1934. These materials also are not to be integrated by reference into any of Capricor’s filings under the Exchange Act unless expressly noted for such purposes.

This notable development reflects Capricor Therapeutics’ commitment to advancing innovative solutions within the medical sphere, particularly catering to patients with DMD cardiomyopathy. The initiation of the BLA submission process underscores the company’s dedication to fostering therapeutic advancements and making a meaningful impact in the realm of muscular dystrophy treatment.

Investors and stakeholders within the healthcare and biopharmaceutical sectors are likely to closely monitor Capricor’s progress with the FDA rolling submission, recognizing the potential implications of this regulatory step for the company’s future operations and therapeutic offerings.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Capricor Therapeutics’s 8K filing here.

Capricor Therapeutics Company Profile

Capricor Therapeutics, Inc (NASDAQ:CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class biological therapeutics for the treatment of rare disorders. Capricor’s lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy.