Caprock Mining Corp

Capricor Therapeutics closed a public offering of 5,073,800 shares, raising $86.3 million. Proceeds will fund product development, manufacturing, and general corporate purposes. Piper Sandler & Co. and Oppenheimer & Co. Inc. managed the offering.

Capricor Therapeutics presents positive three-year safety and efficacy data from Phase II HOPE-2 trial for DMD cell therapy, deramiocel, and initiates BLA submission to FDA. Deramiocel shows sustained cardiac and skeletal muscle benefits, with potential for long-term efficacy.

Capricor Therapeutics announced positive three-year results from its HOPE-2 study for deramiocel, a treatment for Duchenne muscular dystrophy (DMD), showing sustained efficacy and safety, particularly in stabilizing cardiac and skeletal muscle function. The company plans to submit a Biologics License Application to the FDA by the end of 2024, aiming for fast-track approval. Deramiocel has received Orphan Drug Designation and is supported by the Regenerative Medicine Advanced Therapy Designation.

Capricor Therapeutics initiates rolling submission for U.S. approval of deramiocel, a cell therapy for cardiomyopathy in Duchenne muscular dystrophy (DMD) patients, based on HOPE-2 trial data showing significant heart and arm function improvements. The therapy, eligible for priority review, aims to provide significant benefits for DMD patients with cardiomyopathy, currently without treatments.

Capricor Therapeutics initiates rolling BLA submission to FDA for deramiocel to treat DMD cardiomyopathy, aiming to complete by end of 2024, potentially eligible for priority review.

Capricor Therapeutics initiated a rolling BLA submission with the FDA for deramiocel, aiming for full approval to treat DMD cardiomyopathy by end of 2024. Deramiocel, with Orphan Drug and RMAT designations, may qualify for priority review, offering a novel treatment for DMD, a condition with no current approved therapies.

Capricor Therapeutics has started a rolling BLA submission with the FDA for deramiocel, aiming to treat Duchenne muscular dystrophy cardiomyopathy. The submission, potentially eligible for priority review, is expected to be completed by end of 2024. Deramiocel, a novel treatment, has shown promise in preclinical and clinical studies for its immunomodulatory and regenerative effects.

DelveInsight's Exosomes Pipeline Insight 2024 report details 75+ therapies from 70+ companies, including Innovex Therapeutics, Coya Therapeutics, EV Therapeutics, and others. Key therapies like ExoCoVac, COYA 201, EV-101, and StemXO are in various clinical trial phases. Notable approvals include Aruna Bio's AB126 for acute ischemic stroke and EXO Biologics' EXOB-001 for bronchopulmonary dysplasia. The report covers mechanism of action, route of administration, and market dynamics.

Six clinical-stage biotech companies are advancing Duchenne muscular dystrophy treatments: Wave Life Sciences, Sarepta Therapeutics, Capricor Therapeutics, Edgewise Therapeutics, Italfarmaco, and Avidity Biosciences. These companies focus on various therapeutic approaches, including RNA medicines, gene therapies, myosin inhibitors, and HDAC inhibitors. The global Duchenne treatment market is expected to grow significantly, driven by regulatory approvals and ongoing research.

Capricor Therapeutics signed a deal with Nippon Shinyaku for European commercialization of deramiocel, a DMD treatment, receiving $20 million upfront and potential $715 million in milestones. The partnership aims to bring deramiocel to market, addressing a disease with no cure, and extends Capricor's cash runway into 2026.