Trial Profile
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 25 Mar 2025
Price :
$35
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At a glance
- Drugs Deramiocel (Primary)
- Indications Duchenne muscular dystrophy
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms HOPE-2
- Sponsors Capricor Therapeutics
- 20 Mar 2025 According to a Capricor Therapeutics media release, company announced the U.S. FDA has accepted Biologics License Application (BLA) seeking full approval of deramiocel for the treatment of Duchenne muscular dystrophy (DMD) cardiomyopathy with a Prescription Drug User Fee Act (PDUFA) target action date set for August 31, 2025.
- 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.
- 02 Jan 2025 According to a Capricor Therapeutics media release, company announced the completion of the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking full approval for deramiocel to treat patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy supported by data from its Phase 2 HOPE-2 and HOPE-2 Open Label Extension (OLE) trials.