---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-071396"
form_type: "8-K"
ticker: "APLS"
cik: "0001492422"
company_name: "Apellis Pharmaceuticals, Inc."
filed_at: "2023-03-15T23:59:59+00:00"
generated_at: "2026-06-18T01:55:11.889928+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA extends PDUFA goal date for Apellis' EMPAVELI Injector sNDA

## Summary
- FDA notified Apellis on March 14, 2023 that labeling review is ongoing and the March 15, 2023 PDUFA goal date will be missed.
- New PDUFA goal date for the EMPAVELI Injector (for PNH self-administration) has not yet been determined.
- EMPAVELI (pegcetacoplan) is currently approved for adults with paroxysmal nocturnal hemoglobinuria.
- The injector is an on-body device designed to enhance self-administration of EMPAVELI.

## SEC filing metadata
- accession: 0001193125-23-071396
- form_type: 8-K
- ticker: APLS
- cik: 0001492422
- company_name: Apellis Pharmaceuticals, Inc.
- filed_at: 2023-03-15T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1492422/000119312523071396/0001193125-23-071396-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1492422/000119312523071396/d377141d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-071396
- JSON: https://secwatch.observer/filing/0001193125-23-071396.json
- Plain text: https://secwatch.observer/filing/0001193125-23-071396.txt

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