Capricor Announces Late‑Breaking HOPE‑3 Phase 3 Presentation at MDA 2026

Capricor Therapeutics reported that results from its Phase 3 HOPE‑3 clinical study evaluating deramiocel (CAP‑1002) in Duchenne muscular dystrophy (DMD) were selected for a late-breaking oral presentation at the 2026 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference. The release states the talk is scheduled for March 11, 2026 at 2:45 p.m. ET, will be presented by Craig McDonald, MD, and is listed in the “Florida 4” location. The announcement includes presentation logistics, a brief summary of the HOPE-3 trial design, and statements about the program’s regulatory status.

According to the company, the late-breaking presentation is titled “Confirmation of Musculoskeletal and Cardiac Benefit in DMD from Deramiocel, an Allogeneic Cell Therapy, in the Phase 3 HOPE-3 Study.” The press release describes the session as “late-breaking” and specifies that it will be an oral presentation, without detailing conference criteria or selection standards. It identifies McDonald as the National Principal Investigator for HOPE-3 and notes his academic roles at UC Davis Health. The release then provides a brief overview of how HOPE-3 was conducted.

The press release describes HOPE-3 as a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial with two cohorts: non-ambulatory and ambulatory boys with DMD who met eligibility criteria. It reports total randomized enrollment of 106 participants across the dual-cohort study. As described, participants were randomly assigned to receive deramiocel or placebo every 3 months, for a total of four doses during the first 12 months of the trial. Beyond these elements, the company’s description is limited to what is included in the announcement.

On the regulatory front, Capricor stated that the HOPE-3 clinical study report (CSR) was submitted to the US Food and Drug Administration (FDA). The release frames this submission as intended to address items outlined in a Complete Response Letter and to support the ongoing review of the company’s Biologics License Application (BLA) for deramiocel in DMD, including the company-stated possibility that the FDA could assign a new Prescription Drug User Fee Act (PDUFA) target action date. The announcement also lists regulatory designations: Orphan Drug Designation (FDA and European Medicines Agency), Regenerative Medicine Advanced Therapy designation (US), Advanced Therapy Medicinal Product designation (Europe), and Rare Pediatric Disease Designation (FDA).

The press release does not provide numerical efficacy findings, effect sizes, or statistical results, and it does not include a safety or adverse event summary from HOPE-3. The company says it plans to present Phase 3 results at the MDA session and provides links to conference details and the agenda. Overall, the announcement reads primarily as a scheduling notice, paired with a high-level snapshot of the study setup and the company’s description of its regulatory review status.

Key Takeaways:

• The company reported that HOPE-3 Phase 3 results for deramiocel in DMD were selected for a late-breaking oral presentation at MDA 2026 (March 11, 2026, 2:45 p.m. ET; presenter Craig McDonald, MD; location listed as Florida 4).
• As described in the release, HOPE-3 is a Phase 3 randomized, double-blind, placebo-controlled trial with ambulatory and non-ambulatory cohorts and 106 randomized participants, with dosing every 3 months for four doses in the first 12 months.
• The announcement states that the HOPE-3 CSR was submitted to FDA in support of an ongoing BLA review and lists multiple designations (Orphan Drug in US/EU, RMAT, ATMP, and Rare Pediatric Disease Designation), alongside a company-stated possibility of an updated PDUFA target action date.