---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-238572"
form_type: "8-K"
ticker: "AMLX"
cik: "0001658551"
company_name: "Amylyx Pharmaceuticals, Inc."
filed_at: "2024-10-17T23:59:59+00:00"
generated_at: "2026-05-30T13:21:51.946637+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# HELIOS Phase 2: AMX0035 improves C-peptide AUC by +3.8 min*ng/mL at Week 24 in Wolfram syndrome

## Summary
- Primary endpoint: C-peptide AUC improved at Week 24 (ITT +3.8 min*ng/mL; Per Protocol +20.2) and sustained through Week 48 (+36.7).
- Glycemic control: HbA1c decreased (-0.09% at Week 24 to -0.35% at Week 36); time in target glucose range increased (+5.2% to +12.3%).
- All 12 participants showed stability/improvement on CGIC and PGIC; no serious AEs related to AMX0035; diarrhea most common.
- FDA and EU granted Orphan Drug Designation; company plans to meet FDA to discuss Phase 3, update in 2025.

## SEC filing metadata
- accession: 0001193125-24-238572
- form_type: 8-K
- ticker: AMLX
- cik: 0001658551
- company_name: Amylyx Pharmaceuticals, Inc.
- filed_at: 2024-10-17T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1658551/000119312524238572/0001193125-24-238572-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1658551/000119312524238572/d858945d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-238572
- JSON: https://secwatch.observer/filing/0001193125-24-238572.json
- Plain text: https://secwatch.observer/filing/0001193125-24-238572.txt

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