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.
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Capricor Therapeutics (NASDAQ: CAPR) announced the publication of a preclinical study in Microbiology Spectrum, showcasing the potential of its StealthX™ exosome platform to develop a multivalent vaccine targeting SARS-CoV-2 proteins. The study indicates that engineered exosomes expressing SARS-CoV-2 spike and nucleocapsid proteins can induce strong immune responses. Notably, the combination approach (STX-S+N) demonstrated robust antibody production and T-cell response with minimal protein doses, lacking adjuvants. CEO Linda Marbán highlighted the significance of this platform in generating potentially superior vaccines. The results support further exploration of the StealthX™ platform in expanding Capricor's therapeutic pipeline, especially concerning rapidly evolving viruses.
Capricor Therapeutics (NASDAQ: CAPR) reported promising 18-month results from its HOPE-2 open-label extension study for CAP-1002, aimed at treating Duchenne muscular dystrophy (DMD). Presented by Dr. Craig McDonald at the Muscular Dystrophy Association Clinical & Scientific Conference, the findings show statistically significant improvements in the Performance of the Upper Limb (PUL version 2.0) scale (p=0.02) compared to the placebo group. Both groups showed reduced disease progression after starting treatment. CAP-1002 maintained a good safety profile, and the study indicates potential long-term benefits for patients. The company is advancing to the HOPE-3 Phase 3 trial.
Capricor Therapeutics (NASDAQ: CAPR) reports progress in its HOPE-3 Phase 3 trial for CAP-1002 in Duchenne Muscular Dystrophy (DMD), with enrollment exceeding 30% and an interim analysis expected in Q4 2023. The company also engaged with the FDA for a Biologics License Application (BLA) pathway. A partnership with Nippon Shinyaku expands its DMD franchise in Japan, yielding $12 million upfront and potential milestones of $89 million. Financially, Q4 2022 revenue was approximately $1 million, with a net loss of $7.7 million. Capricor's cash and equivalents totaled $41.4 million, sufficient to fund operations into Q4 2024.
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