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Friday, August 8, 2025

Capricor's DMD Treatment Reaches Critical FDA Milestone: Type A Meeting to Discuss BLA Path



Capricor Therapeutics (NASDAQ: CAPR) has announced a scheduled Type A meeting with the FDA to discuss the regulatory pathway for their Biologics License Application (BLA) for Deramiocel, their lead cell therapy candidate for treating cardiomyopathy in Duchenne muscular dystrophy (DMD).

Due to this meeting, the company has rescheduled its Q2 2025 financial results release to August 11, 2025, after market close, with a conference call at 4:30 p.m. ET. Deramiocel, currently in late-stage development, has shown promising immunomodulatory and anti-fibrotic properties in preserving cardiac and skeletal muscle function in DMD patients. The company has an exclusive commercialization agreement with Nippon Shinyaku Co., Ltd. for Deramiocel in the US and Japan.

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