Capricor Therapeutics Inc Stock Price, News & Analysis

Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on cell and exosome-based therapeutics for rare diseases, will join the Russell 2000® Index and the Russell 3000® Index, starting July 1, 2024.

The inclusion reflects the company's advancements in its lead Duchenne muscular dystrophy program. CEO Linda Marbán, Ph.D., highlighted that this achievement enhances Capricor's visibility within the investment community.

The annual Russell indexes reconstitution ranks the 4,000 largest U.S. stocks by market capitalization, with membership lasting one year. Approximately $10.5 trillion in assets are benchmarked against these indexes, administered by FTSE Russell.

Capricor Therapeutics (NASDAQ: CAPR) announced positive long-term results from the HOPE-2 OLE study for its drug deramiocel (CAP-1002), targeting Duchenne muscular dystrophy (DMD). The study showcased improvements in both skeletal muscle and cardiac function over three years, including left ventricular ejection fraction (LVEF) and indexed volumes. Patients exhibited a statistically significant benefit in the Performance of the Upper Limb (PUL v2.0) score compared to an external comparator. A pre-BLA meeting with the FDA is scheduled for Q3 2024 to expedite the Biologics License Application (BLA) filing. The results will be presented at the PPMD Annual Conference on June 29, 2024.

Capricor Therapeutics (NASDAQ: CAPR) announced a scheduled Pre-BLA (Biologics License Application) meeting with the FDA for deramiocel (CAP-1002), a treatment for Duchenne Muscular Dystrophy (DMD), in the third quarter of 2024.

This meeting aims to finalize the BLA filing plans and outline the rolling submission timeline. CEO Linda Marbán emphasized the urgency and potential approval of deramiocel due to the unmet needs of DMD patients. She also highlighted the necessity of multiple therapies to effectively combat DMD.

Capricor will present the latest 36-month data from the HOPE-2 open-label extension study at the Parent Project Muscular Dystrophy 30th Annual Conference from June 27-29, 2024.

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.