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Cardiol Therapeutics Nominates Dr. Timothy Garnett to Its Board of Directors
Newsfile· 2025-04-29 11:27
Core Viewpoint - Cardiol Therapeutics has nominated Dr. Timothy Garnett, a veteran in the pharmaceutical industry, to its Board of Directors, which is expected to enhance the company's strategic vision and clinical development capabilities as it advances its heart disease therapies [1][3]. Company Overview - Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease [4]. - The company's lead drug candidate, CardiolRx™ (cannabidiol) oral solution, is in clinical development for treating heart disease, specifically targeting inflammation and fibrosis associated with conditions like myocarditis and pericarditis [4][5]. Dr. Timothy Garnett's Background - Dr. Garnett has over 30 years of experience in the pharmaceutical industry, including 20 years at Eli Lilly, where he served as Chief Medical Officer from 2008 to 2021 [2]. - He has a proven track record in leading the development of therapeutics across various fields, including women's health, endocrinology, and neuroscience, resulting in multiple global commercial launches [2]. Clinical Trials and Drug Development - Cardiol has received Investigational New Drug Application authorization from the US FDA to conduct clinical studies for CardiolRx™ in recurrent pericarditis and acute myocarditis [5][6]. - The ongoing MAVERIC trial is a pivotal Phase III study for recurrent pericarditis, while the ARCHER trial is a Phase II study for acute myocarditis, which is a significant cause of heart failure in young adults [6]. Financial Context - Heart failure is a leading cause of death and hospitalization in developed countries, with associated healthcare costs in the US exceeding $30 billion annually [7].
Cardiol Therapeutics Enrolls First Patient in Pivotal Phase III MAVERIC Trial in Recurrent Pericarditis
Newsfile· 2025-04-16 11:27
Core Insights - Cardiol Therapeutics has initiated the pivotal Phase III MAVERIC trial to evaluate CardiolRx™ for preventing recurrent pericarditis, with the first patient enrolled at Northwestern University [3][4][6] - The trial is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy of CardiolRx™ in patients at high risk for disease relapse [3][5][8] - CardiolRx™ has received Orphan Drug Designation from the US FDA and targets the inflammasome pathway, which is crucial in the development of pericarditis [6][12] Company Overview - Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease [11] - The lead drug candidate, CardiolRx™, is an oral solution that aims to inhibit the inflammasome pathway, which is linked to inflammation and fibrosis in heart conditions [11][12] - The company has received FDA authorization for clinical studies evaluating CardiolRx™ in recurrent pericarditis and acute myocarditis [12] Trial Details - The MAVERIC trial aims to enroll 110 patients across approximately 20 clinical sites in the US, Canada, and Europe [8][9] - The primary objective is to evaluate the impact of CardiolRx™ on preventing new episodes of recurrent pericarditis at 24 weeks [8][9] - Previous Phase II data indicated significant reductions in pericarditis pain and inflammation, with a notable decrease in recurrence rates [6][9] Market Context - Recurrent pericarditis affects an estimated 38,000 patients annually in the US, with a significant portion experiencing multiple recurrences [10] - Current treatment options are limited, with the only FDA-approved therapy being costly and primarily used as a third-line intervention [10] - The trial addresses a critical need for new treatment options earlier in the care pathway for patients suffering from this debilitating condition [5][10]
Cardiol Therapeutics Announces Year-End 2024 Update on Operations
Newsfile· 2025-04-01 11:27
Core Insights - Cardiol Therapeutics has reported positive data from the Phase II MAvERIC-Pilot study, supporting the advancement to the Phase III MAVERIC trial for CardiolRx™ in recurrent pericarditis [1][2] - The company completed patient enrollment in the Phase II ARCHER trial for acute myocarditis, with topline data expected in Q2 2025 [1][9] - CardiolRx™ has received Orphan Drug Designation from the U.S. FDA for the treatment of pericarditis, including recurrent cases [3][11] - As of December 31, 2024, the company has cash and cash equivalents of $30.6 million, which is projected to fund operations into Q3 2026 [1][7] MAvERIC Program in Recurrent Pericarditis - CardiolRx™ was granted Orphan Drug Designation in February 2024, addressing a significant unmet need in recurrent pericarditis, which affects approximately 160,000 individuals annually in the U.S. [3][11] - The Phase II MAvERIC-Pilot study demonstrated a marked reduction in pericarditis pain and inflammation, with results presented at the AHA 2024 [2][3] - The Phase III MAVERIC trial will enroll 110 patients at high risk for disease recurrence, focusing on the impact of CardiolRx™ versus placebo [4][11] ARCHER Trial in Acute Myocarditis - The ARCHER trial has completed patient enrollment with over 100 participants across multiple countries, and topline results are expected in Q2 2025 [9][11] - The trial's primary outcome measures include myocardial magnetic resonance imaging parameters, which are critical for assessing heart dysfunction and prognosis in acute myocarditis [9][11] CRD-38 Pre-Clinical Development - Cardiol is developing CRD-38, a subcutaneously administered formulation intended for heart failure treatment, with promising pre-clinical data published in the Journal of the American College of Cardiology [9][14] - The research indicates that CRD-38 may provide cardioprotection by improving cardiac function and reducing inflammation [9][14] Capital Management - Cardiol successfully closed a public offering in October 2024, raising gross proceeds of approximately $15.5 million [7] - The current cash position is expected to support operations and capital requirements through Q3 2026 [7] Outlook - The company anticipates significant milestones in the next 12-18 months, including the enrollment of the first patient in the Phase III MAVERIC trial [8] - The MAVERIC trial is designed in collaboration with global experts and aims to support a New Drug Application with the FDA [8]
Cardiol Therapeutics Announces Publication of Research in the Journal of the American College of Cardiology: Basic to Translational Science That Supports Development of Its Proprietary Subcutaneous Drug Candidate, CRD-38, for the Treatment of Heart Failure
Newsfile· 2025-02-20 12:27
Core Viewpoint - Cardiol Therapeutics has published research supporting its proprietary subcutaneous drug candidate, CRD-38, for treating heart failure, demonstrating improvements in cardiac function and reductions in key mechanisms of heart failure such as cardiac hypertrophy and inflammation [1][2][3] Company Overview - Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease, with its lead drug candidate being CardiolRx™, an oral solution of cannabidiol [6][8] - The company has received Investigational New Drug Application authorization from the US FDA to conduct clinical studies for CardiolRx™ in recurrent pericarditis and acute myocarditis [7] Research Findings - The research published in the Journal of the American College of Cardiology indicates that CRD-38, a subcutaneous formulation of cannabidiol, can prevent heart failure dysfunction and remodeling by preserving mitochondrial function and calcium handling [2][3] - The study highlights that subcutaneous administration of cannabidiol resulted in reduced cardiac fibrosis, hypertrophy, and inflammation, while improving ejection fraction and cardiac output [10] Mechanism of Action - The cardioprotective effects of CRD-38 are attributed to its ability to sustain cardiomyocytes and preserve mitochondrial function, which is crucial for energy production in cardiac cells [3][5] - The research suggests that the cardioprotective effect may involve activation of peroxisome proliferator-activated receptor gamma (PPAR-γ), which helps in maintaining mitochondrial function and redox balance [10]
PRISM MarketView Features Q&A with President and CEO David Elsley: Cardiol Therapeutics Enters Phase 3 Clinical Trial for CardiolRx™ Addressing Patients with Recurrent Pericarditis
Newsfilter· 2024-12-19 13:30
Company Overview - Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease [3] - The company's lead drug candidate, CardiolRx™, is an oral solution containing cannabidiol, which is in clinical development for treating heart disease [3] Clinical Development - CardiolRx™ is entering a late-stage Phase III clinical trial named MAVERIC, targeting patients with recurrent pericarditis who are at high risk for recurrence [2] - The MAVERIC Program includes the Phase II MAvERIC-Pilot study, the Phase II/III MAVERIC-2 trial, and the planned Phase III MAVERIC-3 trial for recurrent pericarditis [4] - The company has also initiated the ARCHER trial, a Phase II study in acute myocarditis, which is a significant cause of heart failure and sudden cardiac death in young adults [4] Market Opportunity - The market for recurrent pericarditis is estimated to be worth $1 billion, presenting a significant opportunity for CardiolRx™ to transform heart disease care [2] - CardiolRx™ is positioned to fill critical gaps in current treatment options, potentially offering a safer, more cost-effective, and disease-modifying solution for patients [2] Regulatory Status - Cardiol Therapeutics has received Investigational New Drug Application authorization from the US FDA to conduct clinical studies for CardiolRx™ in recurrent pericarditis and acute myocarditis [4] - The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, including recurrent pericarditis [4] Financial Position - The company is focused on maintaining a strong financial position to support its clinical development programs and upcoming milestones [2]
PRISM MarketView Features Q&A with President and CEO David Elsley: Cardiol Therapeutics Enters Phase 3 Clinical Trial for CardiolRx™ Addressing Patients with Recurrent Pericarditis
GlobeNewswire News Room· 2024-12-19 13:30
Company Overview - Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on anti-inflammatory and anti-fibrotic therapies for heart disease [3] - The company's lead drug candidate, CardiolRx™, is an oral solution containing cannabidiol, currently in clinical development for heart disease treatment [3] Clinical Development - CardiolRx™ is entering a late-stage Phase III clinical trial named MAVERIC, targeting patients with recurrent pericarditis who are at high risk for recurrence [2] - The MAVERIC Program includes the Phase II MAvERIC-Pilot study, the Phase II/III MAVERIC-2 trial, and the planned Phase III MAVERIC-3 trial [4] - The company has also received FDA authorization for clinical studies evaluating CardiolRx™ for recurrent pericarditis and acute myocarditis [4] Market Opportunity - The market for recurrent pericarditis is significant, with CardiolRx™ positioned to fill critical gaps in current treatment options [2] - CardiolRx™ is expected to be safer, more cost-effective, and disease-modifying, potentially improving the standard of care for patients with recurrent pericarditis [2] Financial Position and Milestones - The company is focused on key upcoming milestones related to the clinical trials and market entry of CardiolRx™ [2] - Cardiol Therapeutics is also developing CRD-38, a novel drug formulation for heart failure, which has substantial healthcare cost implications in the U.S. exceeding $30 billion annually [4]
3 Penny Stocks Ready to Break Out in 2025
MarketBeat· 2024-11-29 13:02
Core Insights - Penny stocks present a high-risk, high-reward investment opportunity, often attracting investors with low prices and potential for significant returns, but they are frequently associated with scams and lack of financial transparency [1][2] Group 1: Vuzix Corp - Vuzix Corp focuses on smart glasses and augmented reality products, particularly for defense and medical applications [4] - The company announced a major contract with a U.S. aerospace and defense company for customized waveguides and launched its Z100 smart glasses for the consumer market [5] - Vuzix reduced its quarterly cash operating expenses by 28% and secured a $10 million equity investment, with an additional $10 million expected [5] - Following positive news, Vuzix experienced a nearly 88% return over five days, reaching a 52-week high [6] Group 2: GeoVax Labs Inc - GeoVax Labs is a clinical-stage biotech firm developing vaccines for COVID-19, HIV, and treatments for solid tumor cancers [7] - The company reported positive Phase 2 trial results for its dual-antigen COVID vaccine candidate, GEO-CM04S1, and received a $400 million BARDA Project NextGen Award [8] - Analysts have given GeoVax a Buy rating with a consensus price target of $14.20, indicating over 400% upside potential from current levels [9] Group 3: Cardiol Therapeutics Inc - Cardiol Therapeutics is developing CardiolRx, which has shown strong results in a Phase 2 study for recurrent pericarditis and is preparing for late-stage clinical trials [10] - The company was added to PRISM Marketview's Emerging Biotech Index, enhancing its profile, although it has lost nearly half its value since June [11] - Cardiol Therapeutics has a current price target of $8.75, with a recent stock price of $1.58 [10]
Cardiol Therapeutics reports promising Phase II results for recurrent pericarditis therapy
Proactiveinvestors NA· 2024-11-18 17:36
About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...
Cardiol Therapeutics' Phase II MAvERIC-Pilot Clinical Results in Recurrent Pericarditis Presented at the American Heart Association Scientific Sessions 2024
Newsfile· 2024-11-18 16:37
Cardiol Therapeutics' Phase II MAvERIC-Pilot Clinical Results in Recurrent Pericarditis Presented at the American Heart Association Scientific Sessions 2024November 18, 2024 11:37 AM EST | Source: Cardiol Therapeutics Inc.Marked and rapid reductions in both pericarditis pain and inflammation  maintained throughout the 26-week studyEpisodes of pericarditis per year substantially reduced MAvERIC-Pilot results support advancing CardiolRx™ into the Phase II/III MAVERIC-2and the Phase III MAVERIC-3 ...
Cardiol Therapeutics Inc. Added to PRISM Emerging Biotech Index
GlobeNewswire News Room· 2024-11-13 13:00
NEW YORK, Nov. 13, 2024 (GLOBE NEWSWIRE) -- PRISM MarketView, a leading provider of market insights and company news, proudly announces that Cardiol Therapeutics Inc. (NASDAQ: CRDL, TSX: CRDL) has been added to the PRISM Emerging Biotech Index, which spotlights companies leading innovation and creating market impact within the biotech sector. Cardiol’s focus on anti-inflammatory and anti-fibrotic therapies for heart disease, including its lead candidate CardiolRx™, positions it as a pioneer in addressing ma ...