Capricor Therapeutics Awaits FDA Review for Duchenne Therapy

Published 1 days agoCAPR

Capricor Therapeutics Awaits FDA Review for Duchenne Therapy

Capricor Therapeutics is currently waiting for an important decision from the FDA regarding their Duchenne muscular dystrophy treatment, deramiocel. As of March 4, 2025, the FDA has granted Priority Review status to Capricor's Biologics License Application for deramiocel, which sets the stage for a potential decision by August 31, 2025. This cell therapy focuses on treating cardiomyopathy, a common, severe complication in DMD patients.

Key clinical trial data has shown that deramiocel could significantly impact the progression of DMD-related cardiac issues. The company has also secured Orphan Drug Designation in both the United States and Europe, along with other crucial regulatory statuses that highlight the therapy's potential impact in these territories. Capricor has aligned with Nippon Shinyaku for future commercialization in the U.S. and Japan, pending regulatory approvals.

Market-wise, Capricor's stock performance recently faced a setback. By the latest report, shares were valued at $10.50, representing a $1.36 drop from previous levels, as noted by Reuters. Despite the fluctuations, ongoing developments with deramiocel's regulatory progress remain a core focus for investors and stakeholders.

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