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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) announced that the FDA has scheduled a Pre-BLA meeting in Q3 2024 for the company's lead product, deramiocel (CAP-1002), aimed at treating Duchenne Muscular Dystrophy (DMD). The meeting will finalize BLA filing plans and outline a rolling submission timeline. Capricor's CEO, Linda Marbán, emphasized the urgency due to the unmet needs of DMD patients and the potential of deramiocel as an anchor therapy. Additionally, Capricor will present the latest 36-month data from the HOPE-2 Open Label Extension (OLE) study at the Parent Project Muscular Dystrophy 30th Annual Conference from June 27-29, 2024.
Capricor Therapeutics (NASDAQ: CAPR) announced a successful Type-B meeting with the FDA for their lead asset, CAP-1002, aimed at treating Duchenne muscular dystrophy (DMD). The FDA approved a rolling Biologics License Application (BLA) submission, set to begin in Q3 2024. The rolling BLA process could streamline regulatory review and reduce risks. The company also received positive clinical results from their HOPE-2 and HOPE-2 OLE studies, with additional data pending from the HOPE-3 trial. The WHO selected 'Deramiocel' as the International Nonproprietary Name for CAP-1002. Capricor could also receive a Priority Review Voucher following FDA approval due to its rare pediatric disease designation. This regulatory progress signifies pivotal steps toward the potential commercialization of CAP-1002.
Capricor Therapeutics (NASDAQ: CAPR) has announced positive 3-year results from their HOPE-2 open-label extension (OLE) study involving CAP-1002 for treating Duchenne muscular dystrophy (DMD). The study showed continued benefits in skeletal muscle function and cardiac function, with patients experiencing a statistically significant reduction in the decline of upper limb function (PUL 2.0) and stabilization in left ventricular ejection fraction (LVEF). These results were recently shared with the FDA at a Type-B meeting in May 2024, and detailed results will be presented at the Parent Project Muscular Dystrophy (PPMD) 30th Annual Conference in late June 2024. The company plans to release topline results from their Phase 3 HOPE-3 pivotal trial in Q4 2024.
Capricor Therapeutics (NASDAQ: CAPR) announced its Q1 2024 financial results and provided a corporate update. Key highlights include the completion of enrollment for the HOPE-3 Phase 3 trial (Cohort A) of CAP-1002 for Duchenne Muscular Dystrophy (DMD) and the receipt of a $10 million milestone payment from Nippon Shinyaku. Capricor held a successful Type-B CMC FDA meeting and plans to report 3-year HOPE-2 OLE data in Q2 2024. Financially, the company reported $4.9 million in Q1 2024 revenues, up from $3 million in Q1 2023, with a net loss of $9.8 million. Capricor's cash position stands at $39.9 million, sufficient to cover expenses into Q1 2025.
Capricor Therapeutics is set to present updates on its exosome platform technology at the ASGCT 27th Annual Meeting, showcasing a potential exosome-based approach for treating arginase-1 deficiency (ARG1-D), a rare genetic metabolic disease. The preclinical findings demonstrate the therapeutic potential of Capricor's StealthX™ exosome platform technology in delivering enzyme-replacement therapies. The company aims to leverage partnership opportunities to advance its exosome platform for therapeutic and vaccine development.
Capricor Therapeutics (CAPR) is set to present at various upcoming scientific and medical conferences, showcasing their transformative cell and exosome-based therapeutics for rare diseases. The company will be discussing potential applications for the treatment of rare diseases like Arginase-1 Deficiency and Duchenne Muscular Dystrophy. The presentations will cover advancements in targeted cargo delivery and disease modification in later-stage patients. These conferences provide a platform for Capricor to share their innovative research and progress in the biotechnology sector.
Capricor Therapeutics, a biotechnology company focusing on cell and exosome-based therapeutics for rare diseases, will announce its first quarter 2024 financial results on May 13, 2024. The company will also host a conference call and webcast at 4:30 p.m. ET on the same day to provide a corporate update.
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