---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-196599"
form_type: "8-K"
ticker: "APLS"
cik: "0001492422"
company_name: "Apellis Pharmaceuticals, Inc."
filed_at: "2022-07-19T23:59:59+00:00"
generated_at: "2026-06-24T12:16:09.940521+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA grants Priority Review for Apellis' pegcetacoplan to treat geographic atrophy; PDUFA Nov 26, 2022

## Summary
- FDA accepted and granted Priority Review for intravitreal pegcetacoplan NDA for geographic atrophy (GA).
- PDUFA target action date set for November 26, 2022; no advisory committee meeting planned.
- Apellis plans to submit marketing authorization application to European Medicines Agency in H2 2022.

## SEC filing metadata
- accession: 0001193125-22-196599
- form_type: 8-K
- ticker: APLS
- cik: 0001492422
- company_name: Apellis Pharmaceuticals, Inc.
- filed_at: 2022-07-19T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1492422/000119312522196599/0001193125-22-196599-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1492422/000119312522196599/d384280d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-196599
- JSON: https://secwatch.observer/filing/0001193125-22-196599.json
- Plain text: https://secwatch.observer/filing/0001193125-22-196599.txt

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