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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Human Allogeneic Cardiosphere-Derived Cells for the Treatment of Duchenne Muscular Dystrophy

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Human Allogeneic Cardiosphere-Derived Cells for the Treatment of Duchenne Muscular Dystrophy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Dec 2025

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At a glance

  • Drugs Deramiocel (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms HOPE-3
  • Sponsors Capricor Therapeutics

Most Recent Events

  • 16 Dec 2025 According to Capricor Therapeutics media release, the company will host a community webinar to share and discuss positive topline results from Phase 3 HOPE-3 trial and how the findings inform ongoing regulatory discussions, including next steps with the U.S. Food and Drug Administration (FDA). The webinar will be held on Wednesday, December 17, 2025, at 1:00 p.m. ET. Participants are encouraged to submit questions in advance.
  • 03 Dec 2025 According to Capricor Therapeutics media release, company expect that detailed HOPE-3 results will be submitted for presentation at a future scientific meeting and for publication in a peer-reviewed journal.
  • 03 Dec 2025 According to Capricor Therapeutics media release, company plans to submit its response to the Complete Response Letter incorporating HOPE-3 data, following prior alignment with FDA

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