---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-173965"
form_type: "8-K"
ticker: "AMLX"
cik: "0001658551"
company_name: "Amylyx Pharmaceuticals, Inc."
filed_at: "2023-06-23T23:59:59+00:00"
generated_at: "2026-06-13T18:07:54.636911+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Amylyx receives CHMP negative opinion for AMX0035 ALS approval in EU; will seek re-examination

## Summary
- CHMP adopted negative opinion on conditional marketing authorisation for AMX0035 (ALBRIOZA) for ALS in EU.
- Company will request formal re-examination, a ~4-month process with new rapporteur and co-rapporteur.
- Topline results from global Phase 3 PHOENIX study expected mid-2024.
- ALS affects ~30,000 people in Europe; no new ALS innovations approved in EU in over 25 years.
- AMX0035 is approved in the U.S. and with conditions in Canada based on CENTAUR trial data.

## SEC filing metadata
- accession: 0001193125-23-173965
- form_type: 8-K
- ticker: AMLX
- cik: 0001658551
- company_name: Amylyx Pharmaceuticals, Inc.
- filed_at: 2023-06-23T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1658551/000119312523173965/0001193125-23-173965-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1658551/000119312523173965/d470144d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-173965
- JSON: https://secwatch.observer/filing/0001193125-23-173965.json
- Plain text: https://secwatch.observer/filing/0001193125-23-173965.txt

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