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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 announced positive topline data from its Phase II MAvERIC-Pilot study, evaluating CardiolRxTM for treating recurrent pericarditis. The 8-week clinical data showed a significant reduction in pericarditis pain and inflammation. The study involved 27 patients, and 89% continued into the extension phase. Notably, 80% of patients with elevated CRP levels at baseline showed normalization. The primary endpoint revealed a mean pain reduction of 3.7 on the NRS scale. CardiolRxTM was well-tolerated and appears promising for future Phase III trials.

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Cardiol Therapeutics presented its Phase II ARCHER trial at the World Congress on Acute Heart Failure 2024. The trial is evaluating CardiolRx™ in patients with acute myocarditis. The presentation included the trial design, rationale, and baseline data on the first 50 patients randomized.

The ARCHER trial has exceeded 85% of target enrollment, with a target of 100 patients across multiple countries. Its primary measures are cardiac MRI assessments of left ventricular function and myocardial edema/fibrosis. The MAvERIC-Pilot Phase II study for recurrent pericarditis is expected to report topline results in June 2024.

Acute myocarditis is a severe inflammatory condition with significant health risks. Cardiol's CEO highlighted the growing interest in myocarditis treatments and the contributions of clinical collaborators to the study's progress.

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Cardiol Therapeutics Inc. makes significant progress in 2023 and early 2024 with key developments in clinical trials and FDA designations. The company completed patient enrollment in the Phase II MAvERIC-Pilot study for recurrent pericarditis and exceeded 50% enrollment in the Phase II ARCHER trial for acute myocarditis. Topline results expected in Q2 2024. Cash and cash equivalents stand at $34.9 million, funding operations into 2026.
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Cardiol Therapeutics Inc. completes patient enrollment in Phase II study for CardiolRx™ in recurrent pericarditis, with topline results expected in Q2 2024. The study aims to inform a pivotal Phase III trial for potential regulatory approval, following Orphan Drug Designation by the FDA. Recurrent pericarditis, a debilitating heart disease, affects a significant number of patients in the US, leading to high healthcare costs and reduced quality of life.
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Cardiol Therapeutics Inc. receives Orphan Drug Designation from the FDA for its lead small molecule drug candidate, CardiolRx, aimed at treating recurrent pericarditis. The designation is based on pre-clinical and initial clinical data from the MAvERIC-Pilot Phase II study, highlighting the drug's potential to improve patients' lives. Recurrent pericarditis is a rare condition affecting around 38,000 patients annually in the US, with significant impact on quality of life and healthcare costs.
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Cardiol Therapeutics Inc. has announced that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. This means that the Company is now in compliance with all applicable listing standards.
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Cardiol Therapeutics Inc. (CRDL) exceeds 50% patient enrollment for ARCHER, a Phase II trial investigating CardiolRx™ for acute myocarditis treatment.
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Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is conducting MAvERIC-Pilot, a Phase II open-label pilot study investigating the safety, tolerability, and efficacy of CardiolRx™ in patients with recurrent pericarditis. The study, which has enrolled 50% of its 25-patient objective, is anticipated to complete patient recruitment during Q1 2024. The primary efficacy endpoint is the change in patient-reported pericarditis pain using an 11-point numeric rating scale, with secondary endpoints including the NRS score after 26 weeks of treatment and changes in circulating levels of C-reactive protein.
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Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) announced that study results demonstrated that cannabidiol treatment inhibits the mesothelial to mesenchymal transition in an experimental model of pericarditis. The results were presented at the 2023 Annual Meeting of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. This research suggests a potential broader therapeutic benefit of CardiolRx™ in preventing pericarditis complications.
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Cardiol Therapeutics Inc. has achieved over 50% patient enrollment in its Phase II open-label pilot study investigating the safety and efficacy of CardiolRx in patients with recurrent pericarditis. The study aims to evaluate improvement in objective measures of the disease and the feasibility of reducing background therapy. The company expressed gratitude to clinical collaborators and patients for their contribution. Recurrent pericarditis is a debilitating inflammatory heart disease that affects quality of life and physical activity. The study will inform the design of a pivotal Phase III trial for potential regulatory approval of CardiolRx.
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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.

Nasdaq:CRDL

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1.02%
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