08:45 AM EDT, 04/08/2025 (MT Newswires) -- Catalyst Pharmaceuticals ( CPRX ) said Tuesday that Health Canada has accepted the new drug submission for AGAMREE submitted by its sublicensee, Kye Pharmaceuticals.

The application was granted priority review status, which could accelerate approval before the end of the year.

AGAMREE is a treatment intended for Duchenne muscular dystrophy.

If accepted, AGAMREE would become the first approved treatment in Canada specifically for the neuromuscular disease, the company said.

The US Food and Drug Administration approved the drug in October 2023, which became commercially available in the US in March 2024, Catalyst said.

Shares of Catalyst were up 8% in recent premarket activity Tuesday.

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