---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-354716"
form_type: "8-K"
ticker: "AMLX"
cik: "0001658551"
company_name: "Amylyx Pharmaceuticals, Inc."
filed_at: "2026-08-18T11:09:58+00:00"
generated_at: "2026-08-18T11:15:18.852112+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Amylyx reports positive Phase 3 LUCIDITY results for avexitide in post-bariatric hypoglycemia

## Summary
- LUCIDITY met primary endpoint: 55% reduction in composite Level 2/3 hypoglycemic events vs placebo (p=0.000003).
- All secondary endpoints met: reductions in SMBG-measured Level 2, CGM-measured Level 2, and adjudicated Level 3 events.
- Trial enrolled 78 adults with PBH post-RYGB; randomized 3:2 to 90 mg avexitide SC daily or placebo.
- NDA submission to FDA planned by end of 2026; avexitide has Breakthrough Therapy and Orphan Drug designations.
- Avexitide well-tolerated; no serious AEs related to treatment; common AEs: diarrhea, injection site erythema, bruising.

## SEC filing metadata
- accession: 0001193125-26-354716
- form_type: 8-K
- ticker: AMLX
- cik: 0001658551
- company_name: Amylyx Pharmaceuticals, Inc.
- filed_at: 2026-08-18T11:09:58+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1658551/000119312526354716/0001193125-26-354716-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1658551/000119312526354716/d180533d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-354716
- JSON: https://secwatch.observer/filing/0001193125-26-354716.json
- Plain text: https://secwatch.observer/filing/0001193125-26-354716.txt

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