- Latest Presentation at MDA Featuring Phase 3 HOPE-3 Results Supporting Delamiocell in Duchenne Muscular Dystrophy
- The HOPE-3 Clinical Study Report (CSR) has been submitted to the U.S. Food and Drug Administration (FDA) in support of the ongoing BLA review.
SAN DIEGO, Feb. 24, 2026 (Globe Newswire) — Capricore Therapeutics The biotechnology company (NASDAQ: CAPR), which develops transformed cell- and exosome-based therapies for the treatment of rare diseases, today announced that results from the Phase 3 HOPE-3 clinical study of Delamiocell in Duchenne muscular dystrophy (DMD) have been selected for a state-of-the-art oral presentation at the 2026 Muscular Dystrophy Association (MDA) Clinical Science Conference, March 8-11. 2026, Orlando, Florida.
“The selection of HOPE-3 as the latest presentation at the MDA conference recognizes the strength and growing clinical evidence supporting Delamiocel and its potential impact on patients living with Duchenne,” said Linda Malvan, Ph.D., Chief Executive Officer of Capricor. “We look forward to sharing these Phase 3 results with the DMD community as we advance our regulatory efforts, including recently submitting the HOPE-3 clinical trial report to the FDA as part of the ongoing BLA review process. We continue to work toward determining potential approval and remain focused on bringing this therapy to patients as efficiently as possible.”
MDA presentation details
| Date and time: | March 11, 2026, 2:45 PM ET |
| Presentation title: | Confirmation of musculoskeletal and cardiac effects of allogeneic cell therapy Deramiocel in DMD in Phase 3 HOPE-3 trial |
| Presenter: | Craig McDonald, MD (Professor of Physical Medicine and Rehabilitation and Pediatrics at UC Davis Health and National Principal Investigator of the HOPE-3 trial) |
| position: | florida 4 |
This CSR submission was requested by the FDA following previous regulatory communications and is intended to address the items outlined in the Complete Response Letter (CRL) and support the ongoing review of the company’s Biologics License Application (BLA) for delamiocel for Duchenne muscular dystrophy, including the FDA’s potential assignment of a new Prescription Drug User Fee Act (PDUFA) target action date.
Click here for more information about the MDA conference. here. Click to view the meeting agenda. here.
About Duchenne muscular dystrophy
Duchenne muscular dystrophy (DMD) is a severe X-linked genetic disease characterized by progressive muscle degeneration that affects the skeletal, respiratory, and cardiac muscles. This is caused by a lack of functional dystrophin, an important structural protein in muscle cells. DMD affects approximately 15,000 people in the United States, primarily boys. Over time, deterioration of the heart muscle leads to cardiomyopathy and heart failure, which is the main cause of death in DMD. There is no cure and treatment options remain limited.
About Delamiocel
Delamiocell (CAP-1002) is composed of allogeneic cardiomyocyte-derived cells (CDCs), a rare cardiac cell population that has been shown in preclinical and clinical studies to exert potent immunomodulatory and antifibrotic effects in maintaining cardiac and skeletal muscle function in muscular dystrophies such as DMD. CDC works by secreting extracellular vesicles known as exosomes. Exosomes target macrophages and change their expression profile to adopt a healing rather than a pro-inflammatory phenotype. CDC has been investigated in more than 250 peer-reviewed scientific publications and administered to more than 250 subjects in multiple clinical trials.
Delamiocel has received orphan drug designation from both the US FDA and the European Medicines Agency (EMA) for the treatment of DMD. Additionally, it has received Regenerative Medicine Advanced Therapy (RMAT) designation in the United States, Advanced Therapy Medicinal Product (ATMP) designation in Europe, and Rare Pediatric Disease designation from the FDA, which could result in priority review if approved.
About HOPE-3 Phase 3 Study
HOPE-3 is a multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trial consisting of two cohorts evaluating the safety and efficacy of delamiocel in patients with DMD. Nonambulatory and ambulatory boys who met eligibility criteria were randomly assigned to receive either delamiocel or placebo every 3 months for a total of four doses during the first 12 months of the study. A total of 106 subjects were randomized in the dual-cohort study. For more information, visit ClinicalTrials.gov. NCT05126758.
About Capricor Therapeutics
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell- and exosome-based therapies to redefine the treatment landscape for rare diseases. At the forefront of our innovation is our lead product candidate, Delamiocell. This is an allogeneic heart-derived cell therapy currently in late stage development for the treatment of Duchenne muscular dystrophy (DMD). Extensive preclinical and clinical data have demonstrated the potent immunomodulatory and antifibrotic effects of delamiocell to help maintain cardiac and skeletal muscle function in DMD. Capricor is also leveraging the power of exosome technology, using its proprietary StealthX™ platform in preclinical development focused on vaccinology and targeted delivery of oligonucleotides, proteins and small molecule therapeutics, with the potential to treat and prevent a wide range of diseases. At Capricor, we are committed to pushing the boundaries of what is possible and paving the way to transformative treatments for those in need. For more information, please visit: caprico.comand follow Capricorn facebook, Instagram and ×.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release regarding the efficacy, safety and intended uses of Capricor’s product candidates. initiation, conduct, size, timing, and results of clinical trials; Clinical trial enrollment pace. plans for regulatory filings, future research and clinical trials; regulatory developments related to our products, including future interactions with regulatory authorities and our ability to obtain regulatory approval or otherwise bring our products to market; Manufacturing capacity. Regulatory meeting dates. Required regulatory testing may be delayed or failed, which could delay or prevent approval of our products. our ability to achieve product milestones and receive milestone payments from our commercial partners; and other statements regarding Capricor’s management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing words such as “believes,” “plans,” “may,” “anticipates,” “expects,” “estimates,” “should,” “targets,” “intends,” and similar words). “will” and similar expressions) should also be considered forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated in such forward-looking statements. Further information regarding these and other risks that may affect Capricor’s business is contained in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 26, 2025, and in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the Securities and Exchange Commission on November 10, 2025. All forward-looking statements in this press release are based on information available to Capricor as of the date of this press release, and Capricor undertakes no obligation to update these forward-looking statements.
Subject to regulatory approval, Capricor has entered into an agreement with Nippon Shinyaku Co., Ltd. (US subsidiary: NS Pharma, Inc.) for the exclusive commercialization and distribution of its DMD treatment Delamiocel in the United States and Japan. Deramiocel and StealthX™ vaccines are investigational candidates and have not been approved for commercial use in any indication.
For more information, please contact us below.
Capricor Media Contact:
Raquel Cona
KCSA Strategic Communications
rcona@kcsa.com
212.896.1204
Capricor contact information:
AJ Bergman, Chief Financial Officer
abergmann@capricor.com
858.727.1755
Source: Capricor Therapeutics
Released on February 24, 2026