---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-21-268814"
form_type: "8-K"
ticker: "APLS"
cik: "0001492422"
company_name: "Apellis Pharmaceuticals, Inc."
filed_at: "2021-09-09T23:59:59+00:00"
generated_at: "2026-06-29T04:47:52.569283+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Apellis announces mixed Phase 3 GA trial results; OAKS met primary endpoint, DERBY missed

## Summary
- OAKS trial met primary endpoint: monthly pegcetacoplan reduced GA lesion growth by 22% (p=0.0003), every-other-month by 16% (p=0.0052) vs sham at 12 months.
- DERBY trial missed primary endpoint: monthly reduced growth by 12% (p=0.0528), every-other-month by 11% (p=0.0750) vs sham.
- Prespecified combined analysis: monthly reduced growth by 17% (p<0.0001), every-other-month by 14% (p=0.0012) vs sham at 12 months.
- Greater effect in extrafoveal lesions: combined analysis showed 26% (monthly) and 23% (every-other-month) reduction vs sham (p<0.001).
- Company plans to submit NDA to FDA in H1 2022 and MAA in Europe; well-tolerated with low rates of endophthalmitis and intraocular inflammation.

## SEC filing metadata
- accession: 0001193125-21-268814
- form_type: 8-K
- ticker: APLS
- cik: 0001492422
- company_name: Apellis Pharmaceuticals, Inc.
- filed_at: 2021-09-09T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1492422/000119312521268814/0001193125-21-268814-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1492422/000119312521268814/d112979d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-21-268814
- JSON: https://secwatch.observer/filing/0001193125-21-268814.json
- Plain text: https://secwatch.observer/filing/0001193125-21-268814.txt

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