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 company dedicated to the discovery, development, and commercialization of pioneering biological therapeutics for the treatment of rare disorders. With a significant focus on novel treatment methodologies, Capricor leverages an extensive body of scientific research to innovate in the biotech sector.
The company's lead candidate, CAP-1002, is an “off-the-shelf” cardiac cell therapy designed for the treatment of Duchenne Muscular Dystrophy (DMD). CAP-1002 is composed of allogeneic cardiosphere-derived cells (CDCs), a unique cell population known for its potent immunomodulatory properties. These properties help in altering the immune system's activity to stimulate cellular regeneration. The efficacy and safety of CDCs are well-documented, with over 100 peer-reviewed scientific publications and administration to around 140 human subjects across several clinical trials.
Capricor's development pipeline also includes CDC-Exosomes (CAP-2003) and an Exosome-mRNA vaccine. These innovative platforms underline the company's commitment to expanding its therapeutic reach beyond DMD, addressing multiple medical conditions.
The company has recently shared positive updates, such as the 24-month results from the HOPE-2 Open Label Extension Study of CAP-1002 for DMD, highlighting sustained benefits and safety. Additionally, Capricor has ongoing programs addressing the COVID-19 pandemic and exploring new frontiers in exosome-based therapies.
Financially, Capricor continues to achieve crucial milestones, effectively managing its resources to advance its clinical programs. Recent operational highlights include strategic corporate updates and anticipated milestones for the CAP-1002 Duchenne Muscular Dystrophy Program and Exosome Program. The company actively engages with the scientific community through presentations and conference calls, emphasizing transparency and keeping stakeholders informed.
Capricor’s partnerships and collaborations further strengthen its research and development efforts, paving the way for groundbreaking advancements in treating rare and debilitating diseases. The company remains a significant player in the biotechnology sector, committed to transforming innovative research into tangible, life-changing therapies.
Capricor Therapeutics (NASDAQ: CAPR) has entered into an exclusive, worldwide licensing agreement with Johns Hopkins University to integrate engineered exosomes into its therapeutic portfolio. This agreement allows Capricor to develop, manufacture, and commercialize exosome technology for vaccines and therapeutics. CEO Linda Marbán emphasized that this milestone will facilitate expansion into areas of significant unmet medical needs. The collaboration builds on over a decade of research and aims to enhance therapeutic delivery systems using exosomes.
Capricor Therapeutics (NASDAQ: CAPR) reported a net loss of approximately $4.2 million, or $0.21 per share, for Q4 2020, compared to a loss of $1.5 million in Q4 2019. The total net loss for 2020 was about $13.7 million, or $0.88 per share, up from $7.6 million in 2019. The company holds $32.7 million in cash and equivalents as of December 31, 2020, significantly higher than $9.9 million in 2019. The firm is advancing its engineered exosome platform technology and preparing for a pre-IND meeting with the FDA regarding a multivalent vaccine. Top-line data from the Phase II INSPIRE trial are expected in Q3 2021.
Capricor Therapeutics (NASDAQ: CAPR) announced new preclinical data highlighting the effectiveness of its exosome-based mRNA vaccine for COVID-19. The study shows enhanced mRNA expression with lower toxicity compared to lipid nanoparticles, demonstrating functional RNA delivery in live animals. Key findings include real-time imaging of mRNA delivery and no adverse effects. Capricor plans to engage with the FDA regarding clinical development strategies, indicating significant advancements in their therapeutic pipeline.
Capricor Therapeutics (NASDAQ: CAPR) will report its fourth quarter and full year 2020 financial results on March 11, 2021, after market close. A conference call is scheduled for 4:30 p.m. ET that day. The company focuses on developing cell- and exosome-based therapeutics for various diseases, with its lead candidate, CAP-1002, aimed at treating Duchenne muscular dystrophy and COVID-19. Investors can access more details during the call and via the company's website.
Capricor Therapeutics (NASDAQ: CAPR) has licensed technology from Johns Hopkins University for a novel imaging-based serology test for COVID-19. This platform effectively analyzes patient antibodies to various SARS-CoV-2 proteins, potentially improving serology testing by reducing false positives and negatives. Key findings demonstrate the technology’s capability to capture antibodies in their native conformations. The company plans to advance its COVID-19 vaccine development and engage with the FDA regarding future clinical steps.
Capricor Therapeutics (NASDAQ: CAPR) announced a publication demonstrating enhanced potency of cell therapies through specific signaling pathway manipulation. Collaborating with Cedars-Sinai Medical Center, the study highlighted the upregulation of beta-catenin and downregulation of CD90 as key factors in cell line consistency and potency. The findings link therapeutic efficacy to microRNAs in exosomes, supporting Capricor's advances in exosome-based therapeutics for diseases such as Duchenne muscular dystrophy. The company plans further pipeline expansion announcements in mid-2021.
Capricor Therapeutics has partnered with Lonza to enhance the manufacturing of its leading cell therapy candidate, CAP-1002, aimed at treating Duchenne Muscular Dystrophy (DMD) and complications from COVID-19. The collaboration will leverage Lonza’s expertise to support the scale-up process, crucial for late-stage clinical trials and potential commercialization. CAP-1002 has received orphan drug designation from the FDA and has shown promising results in phase 2 trials. Manufacturing operations will commence at Lonza's Houston center.
Capricor Therapeutics (NASDAQ: CAPR) announced that the independent Data and Safety Monitoring Board (DSMB) has approved the continuation of its Phase II clinical trial assessing CAP-1002 for severe COVID-19 treatment. The DSMB's safety review found no significant issues, allowing the trial, which includes up to 60 patients, to proceed. CAP-1002 aims to mitigate the cytokine storm, a severe inflammatory response in COVID-19 patients. Initial case data suggest promise for CAP-1002 in addressing cardiac complications associated with COVID-19, with results expected in H1 2021.
Capricor Therapeutics (NASDAQ: CAPR) announced the initiation of its Phase 2 INSPIRE trial for CAP-1002, focusing on treating severe COVID-19 patients. The first two patients have been dosed, with the study set to enroll up to 60 participants requiring supplemental oxygen. CAP-1002 utilizes allogeneic cardiosphere-derived cells to target the cytokine storm associated with COVID-19. This trial aims to assess the safety and efficacy of the treatment, particularly for patients facing high risks of morbidity or cardiac complications linked to COVID-19.
Capricor Therapeutics (NASDAQ: CAPR) announced positive preclinical data for a multivalent exosome-mRNA vaccine targeting COVID-19, demonstrating long-lasting immunity to multiple SARS-CoV-2 proteins. The company is expanding its exosome platform technology while advancing its CAP-1002 program for Duchenne Muscular Dystrophy. In Q3 2020, Capricor reported a net loss of approximately $3.9 million, with cash and marketable securities totaling $35.3 million. The company aims to initiate patient enrollment in upcoming clinical studies and explore partnerships to enhance its pipeline.
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