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Capricor Therapeutics, Inc. - $CAPR STOCK NEWS

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.

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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.

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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.

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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.

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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.

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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.

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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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Capricor Therapeutics announces positive outcomes from a Type-B meeting with the FDA regarding the CAP-1002 program for Duchenne Muscular Dystrophy. The FDA supports requests for a Pre-BLA meeting and Rolling BLA submission, aligning with the company on non-clinical comparability. Capricor plans to share 3-year safety and efficacy data with the FDA in the second quarter of 2024. The company is on track to potentially accelerate the BLA filing process for CAP-1002 treatment.
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Capricor Therapeutics (CAPR) to present at H.C. Wainwright and Cantor Fitzgerald conferences to discuss progress on CAP-1002 for Duchenne muscular dystrophy.
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Capricor Therapeutics (CAPR) announces positive 24-month results from HOPE-2 open-label extension study of CAP-1002 in Duchenne Muscular Dystrophy. The study shows significant improvements in skeletal and cardiac muscle function, with a 64% reduction in disease progression. CAP-1002 demonstrates a favorable safety profile and potential long-term benefits for patients.
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Capricor Therapeutics announces completion of enrollment in Cohort A of Phase 3 trial for CAP-1002 in Duchenne Muscular Dystrophy, successful interim analysis, and plans for top-line data reporting in Q4 2024. The company also discloses upcoming FDA meeting for commercial manufacturing planning, expansion at San Diego facility, and 3-year data report in Q2 2024. Additionally, Capricor shares updates on a clinical trial collaboration with NIH, financial results, and corporate milestones.
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FAQ

What does Capricor Therapeutics Inc. specialize in?

Capricor specializes in the discovery, development, and commercialization of biological therapeutics for rare disorders.

What is CAP-1002?

CAP-1002 is an off-the-shelf cardiac cell therapy developed for the treatment of Duchenne Muscular Dystrophy (DMD).

What are cardiosphere-derived cells (CDCs)?

CDCs are a unique population of cells known for their immunomodulatory activity, which helps stimulate cellular regeneration.

What recent achievements has Capricor announced?

Recent achievements include positive 24-month results from the HOPE-2 Open Label Extension Study of CAP-1002 for DMD.

How many human subjects have received CAP-1002?

Approximately 140 human subjects have received CAP-1002 across several clinical trials.

What other programs does Capricor have in its pipeline?

Capricor's pipeline includes CDC-Exosomes (CAP-2003) and an Exosome-mRNA vaccine.

Does Capricor have a focus on COVID-19 treatments?

Yes, Capricor has ongoing programs addressing the COVID-19 pandemic.

What financial updates has Capricor recently provided?

Capricor has shared recent operational highlights, including strategic corporate updates and anticipated milestones.

How does Capricor engage with the scientific community?

Capricor actively engages through presentations, conference calls, and webcasts, keeping stakeholders informed.

What makes Capricor a significant player in the biotech sector?

Capricor's commitment to innovative research and development for rare diseases and its strategic partnerships make it a significant player.

Capricor Therapeutics, Inc.

Nasdaq:CAPR

CAPR Rankings

CAPR Stock Data

176.55M
26.04M
8.2%
21.62%
11.12%
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About CAPR

capricor therapeutics, inc. (nasdaq: capr) is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of first-in-class biological therapeutics for the treatment of rare disorders. our innovative technology builds upon a large body of scientific research and enables us to approach the treatment of diseases in novel ways. capricor’s lead candidate, cap-1002, is an “off-the-shelf” cardiac cell therapy that is currently in clinical development for the treatment of duchenne muscular dystrophy (dmd). cap-1002 consists of allogeneic cardiosphere-derived cells, or cdcs, a unique population of cells which include progenitor cells that have been shown to exert potent immunomodulatory activity, which alters the immune system’s activity to stimulate cellular regeneration. cdcs have been the subject of over 100 peer-reviewed scientific publications and have been administered to approximately 140 human subjects across several clinical trials. capricor has