---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-300035"
form_type: "8-K"
ticker: "ANNX"
cik: "0001528115"
company_name: "Annexon, Inc."
filed_at: "2023-12-20T23:59:59+00:00"
generated_at: "2026-06-07T09:49:04.459959+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA aligns with Annexon on vision preservation endpoint for ANX007 GA Phase 3 program; ANX1502 Ph1 positive

## Summary
- FDA agrees to prevention of ≥15-letter BCVA loss as primary endpoint; no requirement for surrogate structural endpoint.
- Two Phase 3 trials: ARCHER II (sham-controlled, ~400 pts, starts mid-2024) and ARROW (head-to-head vs Syfovre, ~500 pts, starts late 2024).
- ANX007 Phase 2 ARCHER showed 72% risk reduction (p=0.006) in BCVA ≥15-letter loss in monthly dose arm vs sham.
- ANX1502 Phase 1 healthy-volunteer data: target drug levels with BID dosing, suppressed C4d biomarker, no serious AEs.
- Company plans to advance tablet formulation of ANX1502 into proof-of-concept trial in CAD patients in 2024.

## SEC filing metadata
- accession: 0001193125-23-300035
- form_type: 8-K
- ticker: ANNX
- cik: 0001528115
- company_name: Annexon, Inc.
- filed_at: 2023-12-20T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1528115/000119312523300035/0001193125-23-300035-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1528115/000119312523300035/d649765d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-300035
- JSON: https://secwatch.observer/filing/0001193125-23-300035.json
- Plain text: https://secwatch.observer/filing/0001193125-23-300035.txt

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