Catalyst Pharmaceuticals: Health Canada accepts AGAMREE NDS with Priority Review for DMD

CATALYST PHARMACEUTICALS, INC.

Health Canada accepted New Drug Submission for AGAMREE (corticosteroid) for Duchenne muscular dystrophy.
Submission granted Priority Review; potential marketing authorization before end of 2025.
If approved, AGAMREE would be first and only DMD treatment indicated in Canada.
AGAMREE already FDA-approved (Oct 2023) and commercially available in the U.S. since March 2024.
Sub-licensee Kye Pharmaceuticals markets FIRDAPSE in Canada for LEMS.

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