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Deramiocel - Capricor Therapeutics

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Drug Profile

Deramiocel - Capricor Therapeutics

Alternative Names: Allogeneic adult stem cell therapy for myocardial infarction - Capricor; Allogeneic cardiosphere-derived cells - Capricor; Allogeneic CDCs - Capricor; Allogenic derived cells - Capricor; CAP-1002

Latest Information Update: 26 Aug 2026

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At a glance

  • Originator Capricor
  • Developer Capricor; Capricor Therapeutics; Medical University of South Carolina
  • Class Exosome therapies; Stem cell therapies
  • Mechanism of Action Exosome replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Duchenne muscular dystrophy
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Duchenne muscular dystrophy
  • Phase II COVID 2019 infections
  • Phase I/II Cardiomyopathies
  • Discontinued Heart failure; Myocardial infarction

Most Recent Events

  • 24 Aug 2026 FDA assigns PDUFA action date of 22/11/2026 for Duchenne muscular dystrophy (In adolescents, In children, In the elderly, In adults) in USA
  • 24 Aug 2026 US FDA extends PDUFA Target Action Date for submitted BLA of Deramiocel for Duchenne muscular dystrophy
  • 13 Aug 2026 Capricor Therapeutics initiates regulatory engagement in Europe and Japan for Deramiocel for Duchenne muscular dystrophy

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