Cardiol Therapeutics Inc. reported that it has exceeded the 50 % patient enrollment target in its pivotal Phase III MAVERIC trial, which evaluates CardiolRx™ for preventing recurrence of pericarditis. The milestone was reached with more than 15 leading cardiovascular centers in the United States actively enrolling patients, and additional sites in Europe and Canada are being activated to accelerate recruitment. Management expects full enrollment by the second quarter of 2026.
Achieving the 50 % enrollment benchmark is a key inflection point for the program. It reduces the clinical risk profile of CardiolRx, brings the company closer to a potential regulatory submission, and strengthens its positioning as a first‑in‑class, non‑immunosuppressive oral therapy for a disease with limited treatment options. CardiolRx has also received orphan drug designation from the U.S. FDA for recurrent pericarditis, which provides market exclusivity and other incentives that could accelerate commercialization once efficacy data are available.
Cardiol Therapeutics remains a clinical‑stage company with ongoing losses and a cash burn that has been offset by recent financing. The latest round of capital raised has extended the company’s runway into the third quarter of 2027 and fully funded the MAVERIC trial. In its most recent earnings release, the company reported a trailing earnings‑per‑share of –$0.30 and a Q3 2025 EPS of –$0.09, underscoring the need for continued investment until the trial reaches completion and regulatory approval.
Chief Medical Officer Dr. Andrew Hamer said, “Surpassing 50 % enrollment in MAVERIC is an important milestone for our Phase III program and reflects both the high unmet medical need in recurrent pericarditis and the confidence investigators have in the scientific rationale and rigorous design of this pivotal trial.” The statement highlights the strong investigator engagement and the scientific robustness of the study design.
With full enrollment projected for the second quarter of 2026, Cardiol Therapeutics will be positioned to deliver the next set of efficacy data. Successful completion of the trial could pave the way for a regulatory submission and, ultimately, a market entry that addresses a critical unmet need in pericarditis treatment.
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