secwatch.observer — SEC 8-K summary
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Issuer:     Apellis Pharmaceuticals, Inc. (APLS)
CIK:        0001492422
Form:       8-K
Filed at:   2022-08-24T23:59:59+00:00
Accession:  0001193125-22-228145
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Apellis reports 24-month Phase 3 data: pegcetacoplan shows increasing efficacy in GA
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- At 24 months, monthly pegcetacoplan reduced GA lesion growth 19% in DERBY (p=0.0004) and 22% in OAKS (p<0.0001) vs sham.
- Between months 18-24, treatment effect accelerated: DERBY monthly 36% (p<0.0001), OAKS monthly 24% (p=0.0080) reduction.
- Safety profile consistent; infectious endophthalmitis rate 0.034% per injection, no occlusive vasculitis or retinitis over 24 months.
- US PDUFA target action date Nov 26, 2022; EU marketing authorization application planned by end of 2022.
- Key secondary visual function endpoints showed no clinically meaningful difference at 24 months, attributed to endpoint limitations.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1492422/000119312522228145/0001193125-22-228145-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1492422/000119312522228145/d305749d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-228145

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