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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 it will present three-year safety and efficacy results from its HOPE-2 open-label extension (OLE) study for deramiocel, its lead asset for treating Duchenne muscular dystrophy (DMD). The data will be presented in a late-breaking poster at the 29th Annual Congress of the World Muscle Society (WMS 2024) in Prague, Czechia, from October 8-12, 2024.
The presentation, titled "Multi-modal benefits of deramiocel (CAP-1002) in late-stage patients with DMD: a new treatment approach to target skeletal and cardiac muscle pathogenesis (HOPE 2-OLE trial: 36-month data)," will be led by Dr. Craig McDonald from UC Davis. It will take place on October 11, 2024, from 9:45-10:45 a.m. EDT.
Linda Marbán, Ph.D., CEO of Capricor, stated that these results support the company's recent decision to begin filing a Biologics License Application (BLA) for potential approval of deramiocel to treat patients with DMD-cardiomyopathy.
Capricor Therapeutics (NASDAQ: CAPR) has announced its intent to file a Biologics License Application (BLA) for deramiocel, a potential treatment for Duchenne muscular dystrophy (DMD) cardiomyopathy. Key points include:
1. The BLA filing is planned to commence in October 2024, with full submission expected by year-end 2024.
2. The application will be based on existing cardiac data from Phase 2 HOPE-2 and HOPE-2 Open Label Extension trials, compared to natural history data.
3. The initial label would include all patients with cardiomyopathy associated with DMD.
4. Capricor plans to combine Cohorts A and B of the Phase 3 HOPE-3 clinical trial for potential label expansion to treat DMD skeletal muscle myopathy.
5. Deramiocel has received FDA Orphan Drug Designation and RMAT designation.
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on developing cell and exosome-based therapeutics for rare diseases, has announced an upcoming investor webcast. The event, scheduled for Tuesday, September 24, 2024, at 8:30 a.m. ET, will provide an update on the company's Duchenne muscular dystrophy (DMD) program.
The webcast will include the latest regulatory updates following Capricor's recent meetings with the U.S. Food and Drug Administration (FDA). Investors can participate via conference call or webcast, with dial-in numbers provided for both domestic and international callers. A replay of the webcast will be available on the company's website after the live broadcast.
Capricor Therapeutics (NASDAQ: CAPR) has entered a binding term sheet with Nippon Shinyaku for the commercialization and distribution of deramiocel in Europe for treating Duchenne muscular dystrophy (DMD). The deal includes a $15 million equity investment at a 20% premium and a $20 million upfront payment upon signing the definitive agreement. Potential milestones could reach $715 million, with Capricor receiving a double-digit percentage of product revenue. This extends Capricor's cash runway into 2026 and brings the total potential milestones from combined distribution agreements to approximately $1.5 billion. Capricor will handle development and manufacturing, while Nippon Shinyaku will manage sales and distribution in Europe.
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focusing on rare disease treatments, has announced its participation in several upcoming investor and scientific conferences. The company will present at the H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024, the 6th Annual Exosome-Based Therapeutic Summit from September 17-19, 2024, and the 2024 Cantor Fitzgerald's Global Healthcare Conference on September 18, 2024.
During these events, Capricor management will provide updates on the company's progress, particularly regarding its lead program, deramiocel for Duchenne muscular dystrophy (DMD) treatment. The presentations will include company overviews, one-on-one meetings, and participation in industry panels, offering investors and industry professionals insights into Capricor's latest developments in cell and exosome-based therapeutics.
Capricor Therapeutics (NASDAQ: CAPR) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Positive pre-BLA meeting with FDA for deramiocel in Duchenne Muscular Dystrophy (DMD)
2. Fully enrolled Phase 3 HOPE-3 trial, with top-line data expected in Q4 2024
3. Positive 3-year skeletal and cardiac data from HOPE-2 open-label extension trial
4. Q2 2024 revenue of $4.0 million, up from $3.9 million in Q2 2023
5. Net loss of $11.0 million ($0.35 per share) in Q2 2024
6. Cash position of $29.5 million as of June 30, 2024
7. Financial resources expected to last into Q1 2025
The company continues to progress its StealthX™ exosome platform and explore partnership opportunities.
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on developing cell and exosome-based therapeutics for rare diseases, has announced it will release its second quarter 2024 financial results on August 7, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. ET on the same day to discuss the results and provide a corporate update.
Investors and interested parties can access the call via toll-free (1-800-717-1738) or international (1-646-307-1865) numbers, using the Conference ID: 30827. Alternatively, participants can use the Call me™ link for instant telephone access. A webcast of the call will also be available, with a replay accessible on the company's website following the live broadcast.
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.
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