Catalyst’s AGAMREE® Moves Closer to Canadian Approval for Duchenne Muscular Dystrophy

Catalyst Pharmaceuticals is celebrating a major regulatory milestone as its Canadian partner, Kye Pharmaceuticals, received confirmation that Health Canada has accepted the New Drug Submission for AGAMREE®—a groundbreaking corticosteroid therapy for Duchenne muscular dystrophy (DMD). Even more promising, the submission was granted Priority Review, fast-tracking the evaluation process and opening the door to a potential approval by late 2025. If approved, AGAMREE would become the first treatment option available in Canada specifically for DMD patients.

“We’re incredibly encouraged by Health Canada’s decision to prioritize AGAMREE’s review,” said Catalyst CEO Richard J. Daly. “It highlights the urgency of bringing hope and meaningful treatment options to the DMD community, especially those in underserved regions.” With AGAMREE already FDA-approved in the U.S. for patients two years and older, and now commercially available, this advancement marks another step in Catalyst’s mission to address rare neuromuscular disorders globally.