Capricor Therapeutics Announces FDA Type A Meeting to Discuss Duchenne Muscular Dystrophy Treatment Path
Capricor Therapeutics is coordinating with the FDA on regulatory steps for its Duchenne therapy, with updates expected soon.
Capricor Therapeutics has scheduled a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory path for its Biologics License Application (BLA) for Deramiocel, the company’s lead cell therapy candidate for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD).
According to the company, preclinical and clinical studies suggest Deramiocel has immunomodulatory and anti-fibrotic properties that may help preserve heart and skeletal muscle function in patients with muscular dystrophies such as DMD.
Capricor is also developing therapeutics based on its exosome technology, including the StealthX™ platform, which is in preclinical development for applications such as vaccinology and targeted delivery of oligonucleotides, proteins, and small molecule therapeutics.
The company has an exclusive commercialization and distribution agreement with Nippon Shinyaku Co., Ltd. (and its U.S. subsidiary NS Pharma, Inc.) for Deramiocel in the United States and Japan, pending regulatory approval. Both Deramiocel and StealthX™ vaccine candidates are investigational and not approved for commercial use in any indication.
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