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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: 09 May 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

  • 05 May 2025 According to a Capricor Therapeutics media release, during the meeting, FDA stated that no significant deficiencies have been identified by the Review Committee and that the package is on track for a Prescription Drug User Fee Act (PDUFA) action date of August 31, 2025. The FDA has also confirmed its intent to hold an advisory committee meeting, although an official date has not yet been set.
  • 05 May 2025 According to a Capricor Therapeutics media release, supported by cardiac data from Phase 2 HOPE-2 and HOPE-2 OLE trials, company today announced the completion of a mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for Biologics License Application (BLA) seeking full approval for deramiocel, for patients diagnosed with Duchenne muscular dystrophy cardiomyopathy.
  • 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.

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