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 develops cell and exosome-based therapeutics for rare diseases, with Deramiocel, an allogeneic cardiac-derived cell therapy, as its lead program for Duchenne muscular dystrophy. Company news commonly covers HOPE-3 clinical data, Biologics License Application communications with the FDA, regulatory designations for Deramiocel, and manufacturing activities tied to the DMD program.
Updates also include financial results, corporate presentations at neurology and muscular dystrophy medical meetings, collaboration revenue references tied to its U.S. Distribution Agreement with Nippon Shinyaku, and preclinical work using the StealthX exosome platform for vaccinology and delivery of oligonucleotides, proteins, and small-molecule therapeutics.
Capricor Therapeutics (NASDAQ: CAPR) announced its fourth quarter and full year 2021 financial results, reporting a net loss of $6.2 million for Q4 and $20 million for the year. The company entered an exclusive partnership with Nippon Shinyaku for the commercialization of CAP-1002 for Duchenne Muscular Dystrophy, securing an upfront payment of $30 million and potential milestone payments of up to $705 million. The HOPE-3 Phase 3 trial for CAP-1002 is set to begin, and top-line data from the Phase 2 INSPIRE trial on COVID-19 is expected soon. Capricor's cash reserves stood at $34.9 million as of December 31, 2021.
Capricor Therapeutics (NASDAQ: CAPR) will announce its Q4 and full-year 2021 financial results on March 10, 2022, after market close. A conference call and webcast will follow at 4:30 p.m. ET. The company focuses on cell and exosome-based therapeutics, with its lead candidate, CAP-1002, in clinical development for Duchenne muscular dystrophy and COVID-19 complications. The webcast will be accessible 15 minutes prior to the call, and a replay will be available afterward.
Capricor Therapeutics (NASDAQ: CAPR) has appointed Dr. Daniel Paulson as Vice President of Clinical Development, focusing on the late-stage cell therapy program CAP-1002 and expanding the exosome platform. Dr. Paulson brings nearly 20 years of drug development experience, previously serving at Bayer AG and Sanofi. His expertise will aid in the potential commercialization of CAP-1002, targeting Duchenne muscular dystrophy and cytokine storm in COVID-19 patients. The company aims to advance its exosome technology for nucleic acid delivery in treating various diseases.
Nippon Shinyaku Co., Ltd. and Capricor Therapeutics have formed an exclusive distribution agreement for CAP-1002, aimed at treating Duchenne muscular dystrophy (DMD) in the U.S. This investigational therapy is not yet approved in the U.S. CAP-1002 uses human cardiosphere-derived cells, targeting a range of DMD patients. A Phase II trial showed promise in enhancing upper limb and cardiac functions. The drug has received orphan and RMAT designations from the FDA, paving the way for a Phase III trial, with a potential market launch post-BLA approval.
Capricor Therapeutics (NASDAQ: CAPR) has partnered with Nippon Shinyaku for the exclusive commercialization of its lead asset, CAP-1002, for Duchenne muscular dystrophy (DMD) in the U.S. Capricor will receive an upfront payment of $30 million and potential milestone payments of up to $705 million. The HOPE-3 Phase 3 trial has been approved by the FDA and is set to begin. Capricor will maintain a double-digit revenue percentage from product sales. The collaboration aims to leverage Nippon Shinyaku's expertise in rare diseases and existing DMD treatment portfolio.
Capricor Therapeutics (NASDAQ: CAPR) announced significant progress in its COVID-19 therapeutic development. A study published in the Journal of Biological Chemistry indicates that its exosome-based mRNA vaccine candidate can generate a robust T-cell response, potentially offering long-lasting immunity. Capricor has also completed enrollment for its Phase 2 trial of CAP-1002, aimed at treating severe COVID-19 patients, with topline data expected in Q1 2022. The dual mRNA delivery method could enhance protection against coronavirus variants, showcasing the company's innovative approach to addressing the pandemic.
Capricor Therapeutics (NASDAQ: CAPR) announced that CEO Dr. Linda Marbán will be the keynote speaker at the TriLink Biotechnologies Annual mRNA Day Conference on November 16, 2021. The global virtual event, in collaboration with Genetic Engineering News and The CRISPR Journal, aims to explore advancements in mRNA-based therapeutics. Dr. Marbán emphasized the importance of mRNA technology in treating diseases, particularly post-COVID-19. Capricor continues to develop its leading candidate, CAP-1002, and exosome technology for various diseases.
Capricor Therapeutics has announced significant progress in its clinical programs, including the approval of the Phase 3 HOPE-3 study for CAP-1002 in Duchenne muscular dystrophy (DMD). The positive Phase 2 HOPE-2 data, which met its primary efficacy endpoint with a p-value of 0.01, demonstrated a 71% slowing in disease progression. Additionally, the INSPIRE trial for COVID-19 has completed enrollment with 63 patients. Financially, the company reported a net loss of $3.9 million for Q3 2021, with $40.8 million in cash reserves, sufficient to support operations for two more years.
Capricor Therapeutics (NASDAQ: CAPR) will announce its third quarter financial results on November 9, 2021, after market close. A conference call and webcast will follow at 4:30 p.m. ET. The company focuses on developing cell and exosome-based therapeutics, with its lead candidate, CAP-1002, in clinical trials for Duchenne muscular dystrophy and COVID-19 cytokine storm. The results will provide insights into its ongoing projects and future direction.
Capricor Therapeutics announced positive outcomes from the HOPE-2 trial for CAP-1002, demonstrating significant improvements in Duchenne muscular dystrophy (DMD) patients. The trial met its primary efficacy endpoint of mid-level Performance of Upper Limb (PUL) v1.2 (p=0.01), with additional positive results in skeletal and cardiac functions. CAP-1002 slowed the decline of muscle function by 71% over one year, with significant cardiac improvements (p=0.002). The findings were presented at the World Muscle Society Annual Meeting, indicating potential for advancing into pivotal trials.