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Cardiol Therapeutics Inc
Symbol CRDL
Shares Issued 116,178,130
Close 2026-09-22 C$ 2.67
Market Cap C$ 310,195,607
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Cardiol achieves phase III Maveric enrolment target

2026-09-23 13:35 ET - News Release

Mr. David Elsley reports

CARDIOL THERAPEUTICS ACHIEVES PHASE III MAVERIC ENROLLMENT TARGET AHEAD OF SCHEDULE AND EXPANDS PIVOTAL TRIAL TO STRENGTHEN ASSESSMENT OF CARDIOLRX'S EFFICACY

Cardiol Therapeutics Inc. has made enrolment progress and plans to expand Maveric, the company's pivotal phase III randomized, double-blind, placebo-controlled, multicentre trial evaluating CardiolRx for the reduction in risk of recurrence in patients with recurrent pericarditis. As of Sept. 23, 2026, 110 patients have been enrolled in Maveric, achieving the company's original recruitment target ahead of its end-of-September guidance.

Highlights:

  • Original 110-patient enrolment target achieved ahead of the company's end-of-September guidance;
  • The Maveric steering committee recommends expanding enrolment to up to 150 patients to capture sufficient events for a robust assessment of CardiolRx's potential to reduce recurrence risk; the recommendation follows a blinded review showing fewer-than-expected recurrences -- an observation the company views as encouraging;
  • Top-line results anticipated in mid-2027 following expanded enrolment and study completion;
  • Existing capital expected to finance Maveric completion, with cash runway into Q1 2028.

"A blinded review of events in Maveric patients who have been randomized 1:1 to either CardiolRx or placebo shows a lower level of pericarditis recurrence than anticipated, an observation we view as encouraging, particularly as we are not aware of changes in routine clinical practice that would explain this finding," said David Elsley, president and chief executive officer of Cardiol Therapeutics.

"Our planned enrolment expansion is designed to support the event count needed to preserve the trial's planned statistical power and deliver a more robust assessment of CardiolRx's efficacy. Top-line results are now anticipated in mid-2027, compared with our previous Q1 2027 guidance. With our cash runway extending into Q1 2028, we are in a strong position to complete Maveric and deliver this important clinical readout."

In alignment with the primary end point used in the pivotal trial of the only FDA-approved (U.S. Food and Drug Administration) therapy for recurrent pericarditis, Maveric's primary efficacy analysis will assess time to a first new episode of pericarditis recurrence. This analysis will evaluate the ability of CardiolRx to delay or prevent recurrence over time. The proportion of patients free from a new episode of recurrent pericarditis at the end of the study will be assessed as a secondary end point.

About Cardiol Therapeutics Inc.

Cardiol Therapeutics 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 continuing 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 also studied 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 health care costs in the United States exceeding $30-billion (U.S.) per year.

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