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
Latest Information Update: 26 Jun 2024
At a glance
- Drugs Deramiocel (Primary)
- Indications Duchenne muscular dystrophy
- Focus Registrational; Therapeutic Use
- Acronyms HOPE-2
- Sponsors Capricor Therapeutics
- 25 Jun 2024 According to a Capricor Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) has scheduled a Pre-BLA (Biologics License Application) meeting with the Company in the third quarter of 2024 for deramiocel (CAP-1002), for the treatment of Duchenne Muscular Dystrophy (DMD)
- 11 Jun 2024 According to a Capricor Therapeutics media release, FDA has agreed to a pre-BLA meeting based on their review of clinical data from HOPE-2, HOPE-2 open label extension (OLE) and available data from HOPE-3. The company plans to initiate BLA filing with a rolling submission in the third quarter of 2024 and plans to further outline the submission schedule with the FDA in the coming months.
- 04 Jun 2024 According to a Capricor Therapeutics media release, topline results from this trial expected in the fourth quarter of 2024.