---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-286826"
form_type: "8-K"
ticker: "APLS"
cik: "0001492422"
company_name: "Apellis Pharmaceuticals, Inc."
filed_at: "2023-12-01T23:59:59+00:00"
generated_at: "2026-06-07T19:19:06.194156+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Apellis updates SYFOVRE label to include rare retinal vasculitis risk; rate 0.01% per injection

## Summary
- Updated USPI Warnings/Precautions and Postmarketing Experience sections to include retinal vasculitis with/without occlusion.
- Estimated rate of retinal vasculitis remains rare at 0.01% per injection, based on over 120,000 injections administered as of Nov 18, 2023.
- Label update pursued in collaboration with the FDA.

## SEC filing metadata
- accession: 0001193125-23-286826
- form_type: 8-K
- ticker: APLS
- cik: 0001492422
- company_name: Apellis Pharmaceuticals, Inc.
- filed_at: 2023-12-01T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1492422/000119312523286826/0001193125-23-286826-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1492422/000119312523286826/d616555d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-286826
- JSON: https://secwatch.observer/filing/0001193125-23-286826.json
- Plain text: https://secwatch.observer/filing/0001193125-23-286826.txt

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