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) is a clinical-stage biotechnology leader advancing novel cell and exosome-based therapies for rare diseases. This dedicated news hub provides investors and researchers with essential updates on therapeutic developments, regulatory milestones, and scientific advancements.
Discover comprehensive coverage of CAP-1002 clinical progress for Duchenne muscular dystrophy, StealthXTM platform innovations, and strategic partnerships driving next-generation treatments. Our curated repository ensures access to verified press releases and objective reporting on critical developments in cardiac cell therapies and exosome delivery systems.
Key updates include clinical trial phases, peer-reviewed research publications, manufacturing advancements, and regulatory interactions. Bookmark this page for real-time tracking of Capricor's progress in redefining regenerative medicine through rigorous scientific validation and targeted therapeutic approaches.
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.
OmniAb (NASDAQ: OABI) has announced two strategic appointments to its Board of Directors: Philip J. Gotwals, Ph.D., and Steve Crouse, while Director Sarah Boyce steps down after nearly six years of service. These changes increase the board size to seven members.
Dr. Gotwals brings 30 years of biopharmaceutical experience, notably as Global Head of Business Development and Licensing at Novartis Institutes for BioMedical Research, where his team executed over 50 major strategic transactions. He will serve on the Human Capital Management & Compensation Committee and Science & Technology Committee.
Steve Crouse, currently Senior Vice President and General Manager of Bio-Techne's Analytical Solutions Division, contributes over 20 years of life sciences expertise. He will serve on the Audit Committee and Science & Technology Committee.