Catalyst Pharmaceuticals announces Health Canada’s acceptance of Agamree new drug submission with priority review

Catalyst Pharmaceuticals

8 April 2025 - Catalyst Pharmaceuticals today reported that its sub-licensee in Canada, Kye Pharmaceuticals has announced that Health Canada has accepted the new drug submission 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 authorisation before the end of 2025.

Read Catalyst Pharmaceuticals press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Medicine , Canada , Dossier