Amylyx receives first global approval: Health Canada approves ALBRIOZA for ALS

Amylyx Pharmaceuticals, Inc.

Health Canada approved ALBRIOZA (AMX0035) with conditions for ALS; first marketing approval worldwide.
Approval based on Phase 2 CENTAUR trial showing 2.32-point higher ALSFRS-R score vs placebo over 24 weeks.
Condition requires data from ongoing Phase 3 PHOENIX trial; topline results expected in 2024.
ALBRIOZA expected to be commercially available in Canada within six weeks.
FDA PDUFA date set for Sept 29, 2022; EMA application under review.

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