Orphan Drug Designation Sends Shares of this Dual-Listed Life Science Therapy Company Soaring

Sponsored:

Thursday, February 15, 2024

Orphan drug designation, or ODD, is valuable on both a humanitarian and a profitability basis. And this company is seeing shares rally following news that it was granted the designation for the treatment of pericarditis, the swelling, and irritation of the tissue surrounding the heart. Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announced in a press release today that it had been granted ODD for its lead small molecule drug candidate for the treatment of pericarditis, by the U.S. Food and Drug Administration. CardiolRx™ is currently in Phase II clinical trials for recurrent pericarditis and acute myocarditis.

The designation provides additional benefits to sponsors, including potential seven-year marketing exclusivity, exemptions from certain FDA fees, and tax credits for qualified clinical trials. Products with ODD may also qualify for accelerated regulatory review via Fast Track, Breakthrough Therapy, or Priority Review designations. 

Dr. Andrew Hamer, Cardiol Therapeutics' Chief Medical Officer and Head of Research & Development, had this to say, “The FDA's decision was based on pre-clinical data combined with initial clinical data from the Company's MAvERIC-Pilot Phase II study. This designation reinforces the potential of CardiolRx™ to improve the lives of patients suffering with recurrent pericarditis, a debilitating heart disease associated with symptoms that adversely affect quality of life and physical activity."

Shares were trading up over 26 percent in early afternoon trade.

Sponsored: