---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-254838"
form_type: "8-K"
ticker: "AMLX"
cik: "0001658551"
company_name: "Amylyx Pharmaceuticals, Inc."
filed_at: "2022-09-30T23:59:59+00:00"
generated_at: "2026-06-23T06:23:11.726603+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA approves Amylyx's RELYVRIO for ALS; Phase 2 trial showed slowed physical decline

## Summary
- FDA approved RELYVRIO (AMX0035) for adults with ALS based on Phase 2 CENTAUR trial in 137 participants that met primary efficacy endpoint.
- RELYVRIO significantly slowed loss of physical function vs placebo; can be used as monotherapy or with existing ALS treatments.
- Amylyx priced RELYVRIO below the latest FDA-approved ALS product; expects specialty pharmacies to start filling prescriptions within 4-6 weeks.
- Most common adverse events (>=15% and >=5% over placebo) were diarrhea, abdominal pain, nausea, and upper respiratory tract infection.
- Management to host investor conference call Sept 30 at 8:00 AM ET to discuss approval and commercial plans.

## SEC filing metadata
- accession: 0001193125-22-254838
- form_type: 8-K
- ticker: AMLX
- cik: 0001658551
- company_name: Amylyx Pharmaceuticals, Inc.
- filed_at: 2022-09-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1658551/000119312522254838/0001193125-22-254838-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1658551/000119312522254838/d379888d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-254838
- JSON: https://secwatch.observer/filing/0001193125-22-254838.json
- Plain text: https://secwatch.observer/filing/0001193125-22-254838.txt

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