Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) announced it has been awarded Orphan Drug Designation for its lead drug candidate.
The US Food and Drug Administration (FDA) awarded Cardiol the orphan status for the drug due to its potential use in helping treat both one-time and recurrent pericarditis, the inflammation of the lining around the heart.
Shares of the pharmaceutical company gained close to 25% in New York on Thursday morning to trade near US$1.28 and its Toronto-listed shares were up around 26% at C$1.79.
This regulatory milestone was reached following the evaluation of pre-clinical and initial Phase II clinical data from the MAvERIC-Pilot study
Andrew Hamer, Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL)' chief medical officer, said: “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."
Orphan Drug Designation is granted to treatments targeting conditions affecting fewer than 200,000 individuals in the US, providing benefits such as marketing exclusivity, reduction of fees, and tax incentives
Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL)' MAvERIC-Pilot study aims to further assess the drug's safety, tolerance, and efficacy, with a focus on patient-reported outcomes and biomarkers of inflammation
Patients who suffer from recurrent pericarditis may suffer from symptoms including debilitating chest pain, shortness of breath, fatigue, physical limitations and a reduced quality of life.
--Updated with share price information--