Welcome to our dedicated page for Capricor Therapeutics news (Ticker: CAPR), a resource for investors and traders seeking the latest updates and insights on Capricor Therapeutics stock.
Capricor Therapeutics Inc (NASDAQ: CAPR) generates news primarily around its development of cell and exosome-based therapeutics for rare diseases, with a strong focus on Duchenne muscular dystrophy (DMD). The company’s announcements frequently highlight clinical trial milestones for its lead investigational therapy, Deramiocel (CAP-1002), as well as updates on its StealthX™ exosome platform.
Investors and followers of CAPR news can expect detailed coverage of clinical trial results and regulatory interactions. Recent communications include positive topline results from the pivotal Phase 3 HOPE-3 study of Deramiocel in DMD, information on primary and secondary endpoints such as Performance of Upper Limb (PUL v2.0) and left ventricular ejection fraction, and commentary from clinical investigators. Capricor also reports on its engagement with the U.S. Food and Drug Administration, including a Complete Response Letter for its Biologics License Application and subsequent Type A meeting to align on the role of HOPE-3 data in the regulatory pathway.
News items also cover corporate and financial developments, such as quarterly financial results, public offerings of common stock, and manufacturing readiness at the company’s GMP facility in San Diego, California. In addition, Capricor issues updates on scientific publications and conference presentations, including peer-reviewed work describing Deramiocel’s mechanism of action and data on scalable loading of therapeutic oligonucleotides into exosomes.
For those tracking CAPR, this news feed provides a centralized view of clinical, regulatory, scientific and financing updates directly related to Capricor’s programs. Regular review of these items can help readers follow the progress of Deramiocel in DMD, developments in the StealthX™ platform, and key corporate decisions that shape the company’s therapeutic pipeline.
Capricor Therapeutics (NASDAQ: CAPR) announced a webinar in collaboration with Parent Project Muscular Dystrophy (PPMD) scheduled for July 29, 2025, at 1:00 p.m. ET. The webinar will discuss the status of Capricor's Biologics License Application (BLA) for Deramiocel, their lead product candidate for treating Duchenne Muscular Dystrophy (DMD).
Deramiocel is an allogeneic cardiac-derived cell therapy in late-stage development, demonstrating immunomodulatory and anti-fibrotic properties for preserving cardiac and skeletal muscle function in muscular dystrophies. The company has secured an exclusive commercialization agreement with Nippon Shinyaku Co., Ltd. for Deramiocel distribution in the United States and Japan, pending regulatory approval.
Capricor Therapeutics (NASDAQ: CAPR) received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for Deramiocel, its cell therapy candidate for treating cardiomyopathy in Duchenne muscular dystrophy (DMD).
The FDA stated it cannot approve the BLA in its current form, citing insufficient evidence of effectiveness and the need for additional clinical data. Capricor plans to resubmit the BLA with data from its ongoing Phase 3 HOPE-3 trial, which includes 104 patients, with topline results expected in Q3 2025.
The company will request a Type A meeting with the FDA to discuss next steps. Deramiocel has received multiple designations including Orphan Drug, RMAT, and Rare Pediatric Disease Designation, potentially qualifying for a Priority Review Voucher upon approval.
Capricor Therapeutics (NASDAQ: CAPR) has received positive regulatory updates for Deramiocel, its cell therapy candidate for treating Duchenne Muscular Dystrophy (DMD)-associated cardiomyopathy. The FDA has indicated that an Advisory Committee meeting is not required, and the Biologics License Application (BLA) continues under Priority Review with a PDUFA target date of August 31, 2025.
Key developments include a successful pre-license inspection, mid-cycle review with no major issues, and an upcoming late-cycle review meeting in mid-July. Additionally, four-year data from the HOPE-2 Open-Label Extension study presented at PPMD 2025 Conference showed sustained cardiac function and clinical benefits from long-term Deramiocel treatment.