secwatch.observer — SEC 8-K summary
======================================

Issuer:     Apellis Pharmaceuticals, Inc. (APLS)
CIK:        0001492422
Form:       8-K
Filed at:   2021-09-09T23:59:59+00:00
Accession:  0001193125-21-268814
Event type: other_material
Sentiment:  neutral
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1492422/000119312521268814/0001193125-21-268814-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1492422/000119312521268814/d112979d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-21-268814

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer