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Cardiol Therapeutics (NASDAQ: CRDL) publishes Phase II pericarditis data as Phase III nears full enrollment

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Rhea-AI Filing Summary

Cardiol Therapeutics Inc. reported that results from its Phase II MAvERIC study of CardiolRx™ in recurrent pericarditis have been published in the peer‑reviewed Journal of the American Heart Association. The publication appears as the pivotal Phase III MAVERIC trial evaluating CardiolRx™ in recurrent pericarditis nears full patient enrollment.

The Phase II data describe CardiolRx™ being associated with rapid, sustained reductions in pericarditis pain and inflammation, substantial reductions in pericarditis episodes per year, and a favorable safety and tolerability profile, supporting the design of the Phase III trial. Cardiol also highlights its broader pipeline, including the ARCHER program in acute myocarditis and development of CRD‑38 for inflammatory heart disease, with CardiolRx™ holding U.S. FDA Orphan Drug Designation for pericarditis.

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ClinicalTrials.gov identifier NCT05494788 Completed Phase II MAvERIC-Pilot study in recurrent pericarditis
ClinicalTrials.gov identifier NCT06708299 Ongoing pivotal Phase III MAVERIC trial in recurrent pericarditis
ClinicalTrials.gov identifier NCT05180240 Completed Phase II ARCHER study in acute myocarditis
Heart failure healthcare costs US$30 billion per year Estimated annual heart failure-related healthcare costs in the United States
recurrent pericarditis medical
"The MAVERIC Program is evaluating CardiolRx™ for the treatment of recurrent pericarditis"
Inflammation of the thin sac around the heart that comes back after a first episode. Like a door that keeps sticking shut even after being fixed, recurrent pericarditis involves repeated bouts of chest pain, fever, or fatigue that can require ongoing treatment, tests, or even procedures. Investors track it because recurrent disease affects healthcare spending, drug trial design, regulatory review, and the potential market for therapies aimed at preventing or managing flare-ups.
Orphan Drug Designation regulatory
"The U.S. FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
inflammasome pathway activation medical
"CardiolRx™ modulates inflammasome pathway activation, an intracellular innate immune system response"
double-blind, placebo-controlled medical
"MAVERIC, a randomized, double-blind, placebo-controlled, pivotal Phase III trial"
A clinical trial design in which participants are randomly assigned to receive either the experimental treatment or an inactive substitute (a placebo), and neither the participants nor the researchers know who is receiving which. This setup limits bias and makes it far easier to tell whether a drug or intervention truly works, similar to a blind taste test, so results carry more weight for regulatory decisions and for investors assessing a product’s commercial prospects.
anti-fibrotic therapies medical
"a late-stage life sciences company focused on advancing the development of anti-inflammatory and anti-fibrotic therapies"

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FAQ

What did Cardiol Therapeutics (CRDL) announce in this 6-K filing?

Cardiol Therapeutics announced that Phase II MAvERIC data for CardiolRx™ in recurrent pericarditis were published in the Journal of the American Heart Association, while its pivotal Phase III MAVERIC trial in recurrent pericarditis is nearing full patient enrollment.

What is CardiolRx™ and what conditions is Cardiol Therapeutics (CRDL) targeting?

CardiolRx™ is Cardiol’s lead small‑molecule drug candidate that modulates inflammasome pathway activation. It is being developed for recurrent pericarditis and acute myocarditis, inflammatory heart diseases linked to pain, shortness of breath, fatigue, and risks such as heart failure and sudden cardiac death.

What are the key findings from the Phase II MAvERIC study reported by CRDL?

The Phase II MAvERIC study reported CardiolRx™ was associated with rapid, sustained reductions in pericarditis pain and inflammation, substantial reductions in pericarditis episodes per year, and a favorable safety and tolerability profile, providing clinical rationale for the pivotal Phase III MAVERIC trial.

What is the MAVERIC Phase III trial mentioned by Cardiol Therapeutics (CRDL)?

MAVERIC is a randomized, double‑blind, placebo‑controlled, pivotal Phase III trial evaluating CardiolRx™ for reducing the risk of recurrent pericarditis. Cardiol states that enrollment is approaching completion, and the design was informed by the earlier Phase II MAvERIC‑Pilot study.

What regulatory status does CardiolRx™ have according to Cardiol Therapeutics (CRDL)?

Cardiol reports that the U.S. FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, including recurrent pericarditis. This designation is intended for therapies targeting rare diseases and can provide certain development and market exclusivity incentives.

What other programs besides MAVERIC is Cardiol Therapeutics (CRDL) pursuing?

Beyond MAVERIC, Cardiol runs the ARCHER Program, which completed a Phase II study of CardiolRx™ in acute myocarditis, and is developing CRD‑38, a novel subcutaneous formulation intended for inflammatory heart disease, including heart failure, a major cause of hospitalization and mortality.

 

 

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of July 2026

Commission File Number: 001-40712

Cardiol Therapeutics Inc.
(Translation of registrant's name into English)

602-2265 Upper Middle Road East, Oakville, Ontario, Canada L6H 0G5
(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

[   ] Form 20-F     [X] Form 40-F

 

 

 
 

 

SUBMITTED HEREWITH

Exhibits

Exhibit   Description
     
99.1   News Release dated July 14, 2026 - Cardiol Therapeutics' Phase II Recurrent Pericarditis Data Published in the Journal of the American Heart Association

 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

  CARDIOL THERAPEUTICS INC.
  (Registrant)
     
Date: July 14, 2026 By: /s/ Christopher Waddick
    Christopher Waddick
  Title: Chief Financial Officer

 

 

EXHIBIT 99.1

 

 

 

 

 

Cardiol Therapeutics' Phase II Recurrent Pericarditis Data Published in the Journal of the American Heart Association

Peer-reviewed JAHA publication strengthens the foundation for Cardiol's pivotal Phase III MAVERIC trial as enrollment nears completion.

TORONTO, July 14, 2026 /CNW/ - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a late-stage life sciences company advancing anti-inflammatory and anti-fibrotic therapies for heart disease, today announced the publication of its Phase II MAvERIC study results in the Journal of the American Heart Association ("JAHA"). The publication comes as the pivotal Phase III MAVERIC trial nears full patient enrollment.

The publication describes clinical findings in which CardiolRx™ was associated with rapid and sustained reductions in pericarditis pain and inflammation in patients with a high baseline disease burden. The study also reported substantial reductions in pericarditis episodes per year and a favorable safety and tolerability profile. Together, these findings provide the strong clinical rationale for MAVERIC, a randomized, double-blind, placebo-controlled, pivotal Phase III trial evaluating CardiolRx™ for reducing the risk of pericarditis recurrence.

"The publication of these results in the Journal of the American Heart Association makes the full body of peer-reviewed Phase II evidence available to the broader cardiovascular community," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics. "The publication provides comprehensive details of findings previously presented at the American Heart Association Scientific Sessions, including clinically important reductions in pain, inflammation, and recurrences with CardiolRx™, a favorable safety and tolerability profile, and its potential to offer a non-immunosuppressive treatment for patients living with recurrent disease. These findings directly informed the design of MAVERIC, our pivotal Phase III study. With enrollment now approaching completion, we believe the strong level of interest highlights the unmet need in this patient population and reinforces our confidence in the potential of CardiolRx™ to advance the standard of care."

The full publication is available in the Journal of the American Heart Association: www.ahajournals.org/doi/full/10.1161/JAHA.125.047605

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a late-stage life sciences company focused on advancing the development of anti-inflammatory and anti-fibrotic therapies for heart disease. The Company's lead small-molecule drug candidate, CardiolRx™, modulates inflammasome pathway activation, an intracellular innate immune system response known to play an important role in the development and progression of inflammation and fibrosis associated with pericarditis, myocarditis, and heart failure.

The MAVERIC Program is evaluating CardiolRx™ for the treatment of recurrent pericarditis, an inflammatory disease of the pericardium associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, which can lead to physical limitations, reduced quality of life, emergency department visits, and hospitalizations. The program comprises the completed Phase II MAvERIC-Pilot study (NCT05494788) and the ongoing pivotal Phase III MAVERIC trial (NCT06708299). The U.S. FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, including recurrent pericarditis.

The ARCHER Program is also studying CardiolRx™, specifically in acute myocarditis - an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in individuals under 35 years of age. The program comprises the completed Phase II ARCHER study (NCT05180240), which evaluated the safety, tolerability, and efficacy of CardiolRx™ in this patient population.

The Company is also developing CRD-38, a novel, subcutaneously administered drug formulation intended for the treatment of inflammatory heart disease, including heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding US$30 billion per year.

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

Cautionary statement regarding forward-looking information:

This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to statements regarding the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease; the Company's intended clinical studies and trial activities and timelines associated with such activities, including the Company's plan to complete the Phase III study in recurrent pericarditis with CardiolRx™; the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation intended for the treatment of inflammatory heart disease, including heart failure, the JAHA publication strengthens the foundation of the pivotal Phase III program in recurrent pericarditis; and with enrollment in MAVERIC now approaching completion we believe the strong level of interest highlights the unmet need in this patient population and reinforces our confidence in the potential of CardiolRx™ to advance the standard of care. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Information Form filed with the Canadian securities administrators and U.S. Securities and Exchange Commission on March 31, 2026, available on SEDAR+ at sedarplus.ca and EDGAR at sec.gov, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise. Investors are cautioned not to rely on these forward-looking statements.

View original content to download multimedia:https://www.prnewswire.com/news-releases/cardiol-therapeutics-phase-ii-recurrent-pericarditis-data-published-in-the-journal-of-the-american-heart-association-302824974.html

SOURCE Cardiol Therapeutics Inc.

 

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/July2026/14/c8968.html

%CIK: 0001702123

For further information: For further information, please contact: Investor.relations@cardiolrx.com

CO: Cardiol Therapeutics Inc.

CNW 07:27e 14-JUL-26

Filing Exhibits & Attachments

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