secwatch.observer — SEC 8-K summary
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Issuer:     Apellis Pharmaceuticals, Inc. (APLS)
CIK:        0001492422
Form:       8-K
Filed at:   2022-03-16T23:59:59+00:00
Accession:  0001193125-22-077217
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Apellis reports positive 18-month Phase 3 data for pegcetacoplan in GA; NDA planned Q2 2022
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- OAKS GA: monthly pegcetacoplan reduced lesion growth 22% (p<0.0001); every-other-month 16% (p=0.0018) at month 18.
- DERBY GA: monthly reduction 13% (p=0.0254); every-other-month 12% (p=0.0332); effects improved vs months 0-6.
- Combined: monthly reduction improved from 13% (months 0-6) to 21% (months 12-18); every-other-month from 12% to 17%.
- Safety: endophthalmitis rate 0.044% per injection; intraocular inflammation 0.23%; no retinal vasculitis or vein occlusion.
- Company plans to submit NDA to FDA for intravitreal pegcetacoplan in GA in Q2 2022.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1492422/000119312522077217/0001193125-22-077217-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1492422/000119312522077217/d223867d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-077217

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