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Cardiol Therapeutics Inc. - CRDL STOCK NEWS

Welcome to our dedicated page for Cardiol Therapeutics news (Ticker: CRDL), a resource for investors and traders seeking the latest updates and insights on Cardiol Therapeutics stock.

Cardiol Therapeutics Inc. (NASDAQ: CRDL, TSX: CRDL) is a pioneering clinical-stage life sciences company specializing in the research and development of anti-inflammatory and anti-fibrotic therapies aimed at treating heart diseases. The company's primary focus is to address the unmet medical needs associated with heart failure, myocarditis, and pericarditis through its innovative drug formulations.

Cardiol is developing CardiolRx™, an oral cannabidiol formulation, which has shown promise in treating inflammatory conditions affecting the heart. The company has received Investigational New Drug Application (IND) authorization from the United States Food and Drug Administration (FDA) to conduct pivotal clinical trials evaluating the safety and efficacy of CardiolRx™ in heart diseases. The two key clinical studies are the ARCHER trial, a Phase II multi-national trial in acute myocarditis, and the MAvERIC-Pilot study, a Phase II open-label pilot study in recurrent pericarditis.

In recent developments, Cardiol has surpassed 50% patient enrollment in the MAvERIC-Pilot study, which aims to investigate the safety, tolerability, and efficacy of CardiolRx™ in patients with recurrent pericarditis. The study is designed to assess patient-reported pericarditis pain and other objective measures of the disease over an 8-week and 26-week period.

Notably, Cardiol has received Orphan Drug Designation (ODD) from the FDA for the treatment of pericarditis, including recurrent pericarditis, which offers benefits such as potential seven-year marketing exclusivity and tax credits for clinical trials. The ARCHER trial, which addresses acute myocarditis, has also made significant progress, surpassing 50% patient enrollment and expected to complete full enrollment during the third quarter of 2024.

Cardiol's commitment to advancing heart disease therapies is also evident in its development of CRD-38, a novel subcutaneously administered drug formulation of cannabidiol intended for use in heart failure. This innovative treatment approach aims to address a leading cause of death and hospitalization globally, with associated healthcare costs in the United States exceeding $30 billion annually. The company's initiatives are supported by extensive pre-clinical and clinical research, including collaborations with leading academic and medical institutions.

For more information about Cardiol Therapeutics, please visit cardiolrx.com.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has announced the completion of its MAvERIC Phase II study for recurrent pericarditis. The full clinical data will be presented at the American Heart Association Scientific Sessions 2024 on November 18, 2024. The study investigated the impact of CardiolRx™ on patients with symptomatic recurrent pericarditis. The primary endpoint data showed marked reductions in pericarditis pain and inflammation at 8 weeks. The study involved 27 adult participants across eight U.S. clinical sites and consisted of an 8-week treatment period followed by an 18-week extension period. The presentation will include additional endpoints such as freedom from pericarditis recurrence, 26-week pain scores, inflammatory marker levels, and safety outcomes.

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Cardiol Therapeutics (NASDAQ: CRDL, TSX: CRDL) held its annual general and special meeting of shareholders on June 26, 2024. Shareholders voted in favor of all proposed management resolutions. Key resolutions included the re-election of eight directors and the appointment of BDO Canada LLP as auditors. Additionally, the unallocated awards under Cardiol's Omnibus Equity Incentive Plan were approved. The re-elected directors are David Elsley, Peter Pekos, Dr. Guillermo Torre-Amione, Colin Stott, Michael Willner, Jennifer Chao, Chris Waddick, and Teri Loxam. The voting results showed strong support, with directors receiving between 96.01% and 99.66% of the votes cast.

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Cardiol Therapeutics (NASDAQ: CRDL, TSX: CRDL) has announced that its Annual General and Special Meeting of Shareholders will be held virtually on June 26, 2024, at 4:30 p.m. EDT. The meeting will be accessible via a live audio webcast at web.lumiagm.com/253136217. During this event, shareholders can participate and vote on various matters. Cardiol is a clinical-stage company dedicated to developing anti-inflammatory and anti-fibrotic therapies for heart disease. Further details on the AGM and participation instructions are available on Cardiol's investor website.

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FAQ

What is the current stock price of Cardiol Therapeutics (CRDL)?

The current stock price of Cardiol Therapeutics (CRDL) is $1.28 as of December 20, 2024.

What is the market cap of Cardiol Therapeutics (CRDL)?

The market cap of Cardiol Therapeutics (CRDL) is approximately 107.6M.

What is Cardiol Therapeutics Inc. known for?

Cardiol Therapeutics Inc. is known for its research and development of anti-inflammatory and anti-fibrotic therapies for heart diseases like heart failure, myocarditis, and pericarditis.

What is CardiolRx™?

CardiolRx™ is Cardiol Therapeutics' lead product, an oral cannabidiol formulation being developed to treat heart diseases by addressing inflammation and fibrosis.

What are the key clinical trials Cardiol Therapeutics is conducting?

Cardiol Therapeutics is conducting the ARCHER trial for acute myocarditis and the MAvERIC-Pilot study for recurrent pericarditis, both evaluating the safety and efficacy of CardiolRx™.

What is the significance of the Orphan Drug Designation for Cardiol Therapeutics?

The Orphan Drug Designation by the FDA for treating pericarditis provides benefits such as potential seven-year marketing exclusivity, tax credits, and accelerated regulatory review.

What recent milestones has Cardiol Therapeutics achieved?

Cardiol Therapeutics has exceeded 50% patient enrollment for its MAvERIC-Pilot study and ARCHER trial, and completed full enrollment in the MAvERIC-Pilot study, with topline results expected in Q2 2024.

What is CRD-38?

CRD-38 is a novel subcutaneously administered drug formulation of cannabidiol being developed by Cardiol Therapeutics for use in treating heart failure.

Where can more information about Cardiol Therapeutics Inc. be found?

More information about Cardiol Therapeutics Inc. can be found on their official website at cardiolrx.com.

What conditions is CardiolRx™ aiming to treat?

CardiolRx™ is being developed to treat heart conditions like heart failure, recurrent pericarditis, and acute myocarditis.

What are the financial highlights of Cardiol Therapeutics?

Cardiol Therapeutics has operations funded into 2026, reflecting significant progress and financial stability to advance their clinical programs.

What collaborations does Cardiol Therapeutics have for their research?

Cardiol collaborates with leading academic and medical institutions, including the Cleveland Clinic, Mayo Clinic, and Massachusetts General Hospital, for its clinical research programs.

Cardiol Therapeutics Inc.

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