---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-254189"
form_type: "8-K"
ticker: "ANNX"
cik: "0001528115"
company_name: "Annexon, Inc."
filed_at: "2023-10-11T23:59:59+00:00"
generated_at: "2026-06-10T01:37:59.193276+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# EMA grants orphan drug designation to ANX005 for GBS; Phase 3 enrollment complete

## Summary
- European Medicines Agency granted orphan drug designation to ANX005 for Guillain-Barré Syndrome.
- Target enrollment of 225 patients achieved in Phase 3 pivotal study of ANX005 in GBS.
- Company on track to report topline Phase 3 data in first half of 2024.
- EMA stated preliminary data show 'clinically relevant advantage' over intravenous immunoglobulin.
- Orphan designation includes 10 years of EU market exclusivity and reduced regulatory fees.

## SEC filing metadata
- accession: 0001193125-23-254189
- form_type: 8-K
- ticker: ANNX
- cik: 0001528115
- company_name: Annexon, Inc.
- filed_at: 2023-10-11T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1528115/000119312523254189/0001193125-23-254189-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1528115/000119312523254189/d568195d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-254189
- JSON: https://secwatch.observer/filing/0001193125-23-254189.json
- Plain text: https://secwatch.observer/filing/0001193125-23-254189.txt

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