Part of NIPPON SHINYAKU CO
Clinical Trials
13
5 active
Approvals
2
Total approvals
Agencies
1
Regulatory bodies
Founded
1999
Active, not recruiting
5
38.5%
Approved For Marketing
1
7.7%
Completed
6
46.1%
Terminated
1
7.7%
- Capricor Therapeutics will release its second quarter 2026 financial results after market close on Thursday, August 13, 2026. - Management will host a conference call and webcast at 4:30 p.m. ET the same day to discuss results and provide a recent corporate update. - The company's lead candidate, Deramiocel, is an allogeneic cardiac-derived cell therapy in late-stage development for Duchenne muscular dystrophy (DMD). - Capricor is also advancing its StealthX exosome platform for targeted delivery of oligonucleotides, proteins, and small-molecule therapeutics.
- Capricor Therapeutics published a peer-reviewed study in Biomedicines describing a novel in-vitro potency assay that characterizes the anti-fibrotic mechanism of action of Deramiocel for Duchenne muscular dystrophy treatment. - The study demonstrated that cardiosphere-derived cells suppress collagen I and III gene expression in primary human fibroblasts through secreted exosomes and soluble factors, with consistent results across over 100 manufacturing lots. - The validated assay enhances quality control and product consistency for Deramiocel as it advances through late-stage development, with Phase 3 HOPE-3 trial topline data expected in mid-fourth quarter 2025. - Deramiocel has received multiple regulatory designations including Orphan Drug status from FDA and EMA, and Regenerative Medicine Advanced Therapy designation, supporting its potential for treating this rare neuromuscular disorder.
- Capricor Therapeutics has dosed the first subjects in a Phase 1 clinical trial of its StealthX exosome-based vaccine, marking the first-in-human evaluation of this novel platform. - The trial is funded by NIAID under the U.S. Department of Health and Human Services' Project NextGen initiative, which aims to develop next-generation vaccine platforms for broader protection against respiratory viruses. - StealthX offers potential advantages over mRNA vaccines by containing no adjuvants, using a more natural delivery system with native proteins, and allowing rapid adaptability to emerging targets. - Initial data from the study is expected in the first quarter of 2026, with the platform designed for versatility across therapeutic areas including rare diseases and targeted payload delivery.
