---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-172425"
form_type: "8-K"
ticker: "AMLX"
cik: "0001658551"
company_name: "Amylyx Pharmaceuticals, Inc."
filed_at: "2022-06-13T23:59:59+00:00"
generated_at: "2026-06-25T02:23:10.957724+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-22-172425
- form_type: 8-K
- ticker: AMLX
- cik: 0001658551
- company_name: Amylyx Pharmaceuticals, Inc.
- filed_at: 2022-06-13T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1658551/000119312522172425/0001193125-22-172425-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1658551/000119312522172425/d358853d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-172425
- JSON: https://secwatch.observer/filing/0001193125-22-172425.json
- Plain text: https://secwatch.observer/filing/0001193125-22-172425.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.