Cardiol Therapeutics Receives FDA Orphan Drug Designation for CardiolRx

First Berlin Equity Research announced its updated research on Cardiol Therapeutics Inc. (ISIN: CA14161Y2006), confirming Buy recommendation and a price target of USD 3.60. This update comes following Cardiol Therapeutics' announcement that it has received orphan drug designation from the US FDA for its lead drug candidate, CardiolRx, for the treatment of pericarditis and recurrent pericarditis (RP).

The assignment of this designation is based on preclinical and early clinical data from the ongoing Phase II RP study. This recognition by the FDA is viewed positively, suggesting that the undisclosed Phase II study data presented to the agency likely shows favorable results. It confirms First Berlin's optimistic assessment of CardiolRx's prospects in the treatment of RP, highlighting the significant advantages conferred by the designation, including seven years of market exclusivity.

Cardiol Therapeutics also announced that it has completed patient recruitment for the Phase II RP study, with publication of topline results expected in the second quarter of 2024.