Cardiol Therapeutics Advances in Pivotal Phase III Study

Cardiol Therapeutics Inc has initiated a pivotal Phase III study of its promising oral drug candidate, CardiolRxT, for recurrent pericarditis (RP). The development marks a significant milestone aimed at securing potential approval from the U.S. Food and Drug Administration (FDA). The study, a randomized, double-blind, placebo-controlled trial, is led by cardiovascular experts and began at Northwestern University. Enrolling 110 patients across 20 sites in the US, Canada, and Europe, it targets a clear unmet need in RP treatment with a promising non-immunosuppressive oral option.

The drug's development gains further support through its orphan drug designation and strong Phase II results. Success in this trial could back a new drug application to the FDA. The firm is also awaiting results from the ARCHER Phase II study on acute myocarditis, expected soon. First Berlin Equity Research maintains its "BUY" recommendation and a price target of USD 8.50.