Cardiol Therapeu Stock Price, News & Analysis

Cardiol Therapeutics (NASDAQ: CRDL) has announced topline results from its Phase II ARCHER trial evaluating CardiolRx™ in acute myocarditis. The trial demonstrated a notable improvement in left ventricular extracellular volume (p = 0.0538) compared to placebo after 12 weeks of treatment.

The study, which enrolled 109 patients across research centers in the US, France, Brazil, and Israel, showed improvements in multiple cardiac magnetic resonance imaging endpoints, including a significant reduction in left ventricular mass. CardiolRx™ maintained a favorable safety and tolerability profile, consistent with findings from the Phase II MAvERIC trial in recurrent pericarditis.

These results provide clinical proof of concept for CardiolRx™ and support advancing its development for cardiomyopathies, heart failure, and myocarditis. The findings will be submitted for presentation at an upcoming scientific meeting and publication.

Cardiol Therapeutics (NASDAQ: CRDL) has announced the database lock for its Phase II ARCHER trial investigating CardiolRx™ in acute myocarditis patients. The trial, which enrolled over 100 patients across research centers in the United States, France, Brazil, and Israel, is a multi-national, randomized, double-blind, placebo-controlled study.

The study's primary outcome measures evaluate cardiac magnetic resonance imaging parameters after 12 weeks of therapy, focusing on global longitudinal strain and extra-cellular volume. These parameters are crucial prognostic markers for myocarditis patients. Topline results are expected within two weeks of the database lock.

Notably, acute myocarditis currently has no FDA-approved drug therapies. The condition results in an average seven-day hospital stay with 4-6% in-hospital mortality risk, costing approximately $110,000 per stay in the United States.

Cardiol Therapeutics (NASDAQ: CRDL) held its Annual General Meeting of Shareholders on May 28, 2025, where shareholders approved all management resolutions. The company announced the election of eight directors, including new board member Dr. Timothy Garnett, former Chief Medical Officer at Eli Lilly. Dr. Garnett brings over 30 years of pharmaceutical industry experience and will help guide the company's strategic priorities.

The company is currently advancing two key clinical trials: the Phase III MAVERIC trial of CardiolRx™ in recurrent pericarditis and the Phase II ARCHER trial of CardiolRx™ in acute myocarditis, with the latter preparing for database lock and top-line results reporting. Michael Willner, who served as a Board member since September 2021, will continue in an advisory capacity.

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 virtual Annual General Meeting of Shareholders (AGM). The meeting will be held on May 28, 2025, at 4:30 p.m. EDT via live audio webcast at web.lumiagm.com/226536161. Shareholders can find detailed information about participation and voting procedures on the company's website at cardiolrx.com/investors/events-presentations/.

Cardiol Therapeutics has nominated Dr. Timothy Garnett to its Board of Directors, bringing over 30 years of pharmaceutical industry expertise. Dr. Garnett, the former Chief Medical Officer of Eli Lilly (2008-2021), will stand for election at the Company's 2025 Annual General Meeting on May 28.

During his tenure at Eli Lilly, Dr. Garnett led successful therapeutic developments in:

• Women's health
• Endocrinology
• Neuroscience

The nomination coincides with Cardiol's milestone of initiating patient enrollment in their pivotal Phase III MAVERIC trial. Dr. Garnett currently serves as Chair of Ophirex, Director of MapLight Therapeutics, and holds advisory roles at Cambridge Innovation Capital and Recode Health Ventures. His expertise in clinical development and regulatory approval processes aligns with Cardiol's mission to develop anti-inflammatory and anti-fibrotic therapies for heart disease treatment.

Cardiol Therapeutics (NASDAQ: CRDL) has initiated its pivotal Phase III MAVERIC trial by enrolling the first patient at Northwestern University, evaluating CardiolRx™ for preventing recurrent pericarditis. The multi-center, randomized, double-blind, placebo-controlled trial will enroll 110 patients across the US, Canada, and Europe.

The trial follows positive Phase II MAvERIC-Pilot results presented at AHA Scientific Sessions 2024, which demonstrated marked reductions in pericarditis pain, inflammation, and yearly recurrences. CardiolRx™, granted FDA Orphan Drug Designation, is an oral drug targeting the inflammasome pathway.

MAVERIC will assess patients who have been treated with IL-1 blockers for at least 12 months and are scheduled to discontinue treatment. The primary endpoint is freedom from pericarditis recurrence at 24 weeks. The study is being conducted at approximately 20 clinical sites under FDA-authorized IND application.

Cardiol Therapeutics (NASDAQ: CRDL) provided its year-end 2024 operational update, highlighting significant progress in its clinical programs. The company reported positive data from the Phase II MAvERIC-Pilot study for CardiolRx™ in recurrent pericarditis patients, showing marked reductions in pain and inflammation.

Key developments include:

• Completion of patient enrollment in Phase II ARCHER trial for acute myocarditis, with topline data expected Q2 2025
• FDA Orphan Drug Designation granted for CardiolRx™ in pericarditis treatment
• Advancement to Phase III MAVERIC trial for recurrent pericarditis
• Strong financial position with $30.6 million cash as of December 31, 2024, funding operations into Q3 2026

The company plans to initiate patient enrollment in Phase III MAVERIC trial, targeting 50% enrollment in H2 2025 and completion in H1 2026. Additionally, Cardiol is advancing CRD-38, their proprietary subcutaneous formulation of cannabidiol, for heart failure treatment.

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.