Catalyst Pharmaceuticals announces Health Canada’s acceptance of AGAMREE NDS

Catalyst Pharmaceuticals (CPRX) reported that its sub-licensee in Canada, Kye Pharmaceuticals, has announced that Health Canada has accepted the New Drug Submission, NDS, for AGAMREE, a novel corticosteroid treatment for Duchenne muscular dystrophy, for review. The submission has been granted Priority Review, expediting the regulatory process with the potential for marketing authorization before the end of 2025. If approved, AGAMREE would be the first and only treatment option indicated for patients diagnosed with DMD in Canada. “We are pleased that Health Canada has accepted the New Drug Submission for AGAMREE with a Priority Review, recognizing its potential to address a significant unmet need for patients with Duchenne muscular dystrophy in Canada,” stated Richard Daly, President and CEO of Catalyst. “In collaboration with our Canadian sub-licensee, Kye, we remain committed to bringing this innovative therapy to DMD patients and ensuring access, particularly for those in underserved communities.”