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Open-Label Extension of the HOPE-2 Duchenne Muscular Dystrophy Trial

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Trial Profile

Open-Label Extension of the HOPE-2 Duchenne Muscular Dystrophy Trial

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Mar 2025

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At a glance

  • Drugs Deramiocel (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms HOPE-2-OLE
  • Sponsors Capricor

    • Most Recent Events

    • 17 Mar 2025 According to a Capricor Therapeutics media release, data from this study presented as a late breaking poster at 2025 Muscular Dystrophy Association Clinical and Scientific Conference, which began on March 16 and runs through March 19 in Dallas, Texas.
    • 17 Mar 2025 Results presented in the Capricor Therapeutics Media Release.
    • 04 Mar 2025 According to a Capricor Therapeutics media release, based upon data from its Phase 2 HOPE-2 and HOPE-2 Open Label Extension trials the U.S. Food and Drug Administration has accepted for review its Biologics License Application (BLA) seeking full approval for deramiocel. Additionally, the FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of August 31, 2025 and at this time, the FDA has not identified any potential review issues.

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