---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-062878"
form_type: "8-K"
ticker: "AMLX"
cik: "0001658551"
company_name: "Amylyx Pharmaceuticals, Inc."
filed_at: "2024-03-08T23:59:59+00:00"
generated_at: "2026-06-05T00:34:28.293834+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Amylyx Phase 3 ALS trial misses primary endpoint; may withdraw RELYVRIO

## Summary
- PHOENIX trial: no significant difference on ALSFRS-R at Week 48 (p=0.667); secondary endpoints also missed.
- Company may voluntarily withdraw RELYVRIO/ALBRIOZA from market; will decide within 8 weeks after regulatory discussions.
- Promotion paused immediately; drug and patient support remain available for now.
- Study enrolled 664 adults; safety profile consistent, no new signals.
- Phase 3 ORION in PSP and Phase 2 HELIOS in Wolfram syndrome continue as planned.

## SEC filing metadata
- accession: 0001193125-24-062878
- form_type: 8-K
- ticker: AMLX
- cik: 0001658551
- company_name: Amylyx Pharmaceuticals, Inc.
- filed_at: 2024-03-08T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1658551/000119312524062878/0001193125-24-062878-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1658551/000119312524062878/d787565d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-062878
- JSON: https://secwatch.observer/filing/0001193125-24-062878.json
- Plain text: https://secwatch.observer/filing/0001193125-24-062878.txt

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