Welcome to our dedicated page for Cardiol Therapeu news (Ticker: CRDL), a resource for investors and traders seeking the latest updates and insights on Cardiol Therapeu stock.
About Cardiol Therapeutics Inc. (NASDAQ: CRDL; TSX: CRDL)
Cardiol Therapeutics Inc. is a clinical-stage life sciences company dedicated to advancing the treatment of debilitating heart diseases through the development of innovative anti-inflammatory and anti-fibrotic therapies. Headquartered in Oakville, Ontario, Cardiol focuses on addressing critical unmet medical needs in conditions such as recurrent pericarditis, acute myocarditis, and heart failure, which collectively represent significant global health challenges with limited therapeutic options.
Core Business and Product Pipeline
The company’s lead product candidate, CardiolRx™, is a pharmaceutically manufactured oral cannabidiol solution designed to inhibit the inflammasome pathway, a key driver of inflammation and fibrosis in cardiac diseases. CardiolRx is currently being evaluated in multiple clinical trials, including the Phase II ARCHER trial for acute myocarditis and the MAvERIC clinical program for recurrent pericarditis. These studies aim to establish the safety, tolerability, and efficacy of CardiolRx in reducing inflammation, alleviating symptoms, and preventing disease recurrence.
In addition to CardiolRx, Cardiol is developing CRD-38, a novel subcutaneous formulation of cannabidiol targeted at heart failure with preserved ejection fraction (HFpEF). Pre-clinical studies have demonstrated CRD-38’s potential to improve cardiac function, reduce inflammation, and prevent structural damage to the heart.
Strategic Focus on Orphan Diseases
Cardiol’s commitment to addressing rare and underserved conditions is underscored by its receipt of FDA Orphan Drug Designation for CardiolRx in both recurrent pericarditis and acute myocarditis. These designations provide the company with regulatory incentives, including market exclusivity, tax credits, and expedited review pathways, enhancing its competitive positioning in the biopharmaceutical landscape.
Clinical Programs and Milestones
- MAvERIC Program: This multi-phase initiative includes the completed Phase II open-label pilot study and the ongoing MAVERIC-2 and MAVERIC-3 trials. These studies aim to evaluate the impact of CardiolRx on pericarditis pain, inflammation, and recurrence rates, with promising early results showing significant symptom relief and inflammation reduction.
- ARCHER Trial: A Phase II international, randomized, double-blind, placebo-controlled study investigating the safety and efficacy of CardiolRx in acute myocarditis. With no FDA-approved therapies currently available for this condition, the ARCHER trial seeks to address an urgent unmet need.
- CRD-38 Development: Pre-clinical research published in leading cardiovascular journals highlights the cardioprotective effects of CRD-38, including its ability to preserve mitochondrial function and reduce cardiac hypertrophy and remodeling.
Market Significance
Heart diseases such as recurrent pericarditis, myocarditis, and heart failure represent substantial healthcare burdens worldwide, with high rates of hospitalization, mortality, and associated costs. In the United States alone, heart failure-related expenses exceed $30 billion annually. Cardiol’s innovative therapies aim to provide more accessible, non-immunosuppressive treatment options for these conditions, positioning the company as a potential leader in the cardiovascular therapeutics market.
Scientific Expertise and Industry Collaboration
Cardiol leverages state-of-the-art research and collaborations with leading academic and clinical institutions, including the Cleveland Clinic and the Mayo Clinic. Its scientific approach is grounded in targeting key molecular pathways, such as the inflammasome and mitochondrial dysfunction, to address the root causes of inflammation and fibrosis in cardiac diseases.
Competitive Landscape
Operating in a highly specialized segment of the biopharmaceutical industry, Cardiol differentiates itself through its focus on cannabidiol-based therapies for orphan diseases. The company’s strategic emphasis on FDA-regulated clinical trials and its ability to secure regulatory designations provide a significant edge over competitors. Furthermore, its dual focus on oral and subcutaneous drug formulations expands its market potential across diverse patient populations.
Conclusion
Cardiol Therapeutics Inc. is at the forefront of developing transformative therapies for heart diseases characterized by inflammation and fibrosis. With a robust product pipeline, strategic focus on orphan diseases, and collaborations with world-renowned institutions, Cardiol is well-positioned to address critical gaps in cardiovascular care and improve patient outcomes globally.
Cardiol Therapeutics (NASDAQ/TSX: CRDL), a clinical-stage life sciences company specializing in anti-inflammatory and anti-fibrotic therapies for heart disease treatment, has announced its upcoming presentation at the TD Cowen 45th Annual Health Care Conference.
The presentation is scheduled for March 5, 2025, at 11:10 a.m. EST in Boston, MA. Interested parties can access a replay of the live webcast through the 'Events & Presentations' section of Cardiol's investor relations website at cardiolrx.com.
Cardiol Therapeutics (NASDAQ: CRDL) announced the publication of research in the Journal of the American College of Cardiology: Basic to Translational Science supporting their subcutaneous drug candidate CRD-38 for heart failure treatment. The research, conducted by scientists from Tecnológico de Monterrey and DeBakey Heart and Vascular Center, demonstrates that subcutaneously administered cannabidiol improves cardiac function and reduces cardiac hypertrophy, remodeling, inflammation, and cell death.
The study results show that CRD-38 provides cardioprotection through multiple mechanisms, including preservation of mitochondrial function and calcium handling in heart cells. The research utilized multiple heart failure models, including in vivo, ex vivo, and in vitro investigations. Key findings revealed that the drug's cardioprotective effect may depend on PPAR-γ activation, which helps prevent mitochondrial dysfunction.
This research is particularly significant as heart failure with preserved ejection fraction remains a leading cause of hospitalization worldwide, with a five-year mortality exceeding 75% in hospitalized patients.
Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL), a clinical-stage life sciences company specializing in anti-inflammatory and anti-fibrotic therapies for heart disease treatment, has announced its upcoming presentation at the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The presentation is scheduled for February 11, 2025, at 4:00 p.m. EST.
Interested parties can access a live webcast of the presentation through the 'Events & Presentations' section of Cardiol's investor relations website at www.cardiolrx.com/investors/events-presentations/.
Cardiol Therapeutics (NASDAQ: CRDL) reported positive Phase II MAvERIC-Pilot clinical results for CardiolRx™ in treating recurrent pericarditis. The study showed marked improvements in pericarditis pain and inflammation maintained throughout the 26-week study. The trial enrolled 27 participants across eight U.S. clinical sites. Key results include: pain reduction from 5.8 to 1.5 at week 26, CRP normalization in 80% of patients at week 8, and reduction in pericarditis episodes from 5.8 to 0.9 per year. The data supports advancing to Phase II/III MAVERIC-2 and Phase III MAVERIC-3 trials. CardiolRx™ demonstrated safety and tolerability with 95% compliance.
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) announced plans to advance CardiolRx™ into a late-stage clinical trial called MAVERIC-2. This trial will evaluate the impact of CardiolRx™ in recurrent pericarditis patients following cessation of interleukin-1 (IL-1) blocker therapy. MAVERIC-2 is expected to be initiated during Q4 at major pericardial disease centers in the United States and Europe.
The trial is designed as a randomized, double-blind, placebo-controlled Phase II/III study with approximately 110 patients. The primary clinical objective is to assess the impact of CardiolRx™ versus placebo on freedom from a new episode of recurrent pericarditis. This study is expected to run concurrently with the Company's planned Phase III program and report results ahead of the pivotal Phase III study in recurrent pericarditis.
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has announced the successful exercise and closing of the over-allotment option for its public offering. Canaccord Genuity purchased an additional 1,265,625 Class A common shares at US$1.60 per share, resulting in additional gross proceeds of $2,025,000. The total offering, including the over-allotment, now comprises 9,703,125 shares for aggregate gross proceeds of US$15,525,000.
The company plans to use the net proceeds to support the clinical development of CardiolRx for treating recurrent pericarditis, as well as for general and administrative expenses, working capital, and other expenses. The offering was made pursuant to U.S. and Canadian regulatory filings, including a U.S. registration statement on Form F-10 and a Canadian short form base shelf prospectus.
Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL) has successfully closed its public offering of 8,437,500 Class A common shares at US$1.60 per share, raising gross proceeds of US$13.5 million. The company plans to use the net proceeds to support the clinical development of CardiolRx for treating recurrent pericarditis, as well as for general and administrative expenses, working capital, and other expenses.
Canaccord Genuity acted as the sole bookrunner for the offering. The offering was made pursuant to a U.S. registration statement on Form F-10 and the company's existing Canadian short form base shelf prospectus. A final prospectus supplement was filed with securities commissions in Canada (except Quebec) and the SEC in the United States.
Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL) has announced the pricing of its public offering of 8,437,500 Class A common shares at US$1.60 per share, aiming to raise US$13.5 million in gross proceeds. The company plans to use the funds to support the clinical development of CardiolRx for treating recurrent pericarditis, as well as for general expenses and working capital. Canaccord Genuity is acting as the sole bookrunner for the offering, which is expected to close around October 10, 2024. The offering is being made under a U.S. registration statement and Canadian short form base shelf prospectus, with a final prospectus supplement to be filed with relevant securities commissions.
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has filed a preliminary prospectus supplement for a proposed public offering of Class A common shares. The supplement was filed with the SEC and SEDAR+ in connection with the company's short form base shelf prospectus. Canaccord Genuity is acting as the sole bookrunner for the offering.
The net proceeds from the offering will be used to support the clinical development of CardiolRx for the treatment of recurrent pericarditis, as well as for general and administrative expenses, working capital, and other expenses. The offering's final terms, including pricing, will be determined in the context of the market. The closing is subject to customary conditions, including listing approvals from the TSX and Nasdaq.
Interested investors can find detailed information about the offering in the supplement and base prospectus available on SEDAR+ and EDGAR.
Cardiol Therapeutics (NASDAQ: CRDL) announced the completion of target patient enrollment for its Phase II ARCHER trial, evaluating CardiolRx™ in acute myocarditis. The trial, with 100 patients from five countries, aims to assess the safety, tolerability, and impact of CardiolRx™ on myocardial recovery. Primary outcomes include measures of left ventricular function and myocardial edema/fibrosis, with topline results expected early next year. This milestone complements data from the MAvERIC Phase II study on recurrent pericarditis, to be presented in November. Acute myocarditis, a severe inflammatory heart disease, lacks FDA-approved therapies, presenting a significant opportunity for Cardiol.
FAQ
What is the current stock price of Cardiol Therapeu (CRDL)?
What is the market cap of Cardiol Therapeu (CRDL)?
What does Cardiol Therapeutics specialize in?
What is CardiolRx?
What is CRD-38?
What are the key clinical trials conducted by Cardiol?
What regulatory designations has CardiolRx received?
How does CardiolRx work?
What makes Cardiol Therapeutics unique in its industry?
What is the significance of the ARCHER trial?
