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Tuesday, June 17, 2025

Capricor Orphan Drug Designation for Becker Muscular Dystrophy, Regulatory Progress for Duchenne

 

  • U.S. FDA grants Orphan Drug Designation to Deramiocel for the treatment of Becker Muscular Dystrophy, broadening Capricor’s focus in neuromuscular diseases
  • Capricor remains on track for the August 31, 2025, PDUFA date for Deramiocel in Duchenne Muscular Dystrophy following successful FDA Pre-License Inspection

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