secwatch.observer — SEC 8-K summary
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Issuer:     Apellis Pharmaceuticals, Inc. (APLS)
CIK:        0001492422
Form:       8-K
Filed at:   2023-12-14T23:59:59+00:00
Accession:  0001193125-23-294892
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Apellis receives negative trend vote on EU MAA for pegcetacoplan; expects CHMP negative opinion in Jan 2024
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- CHMP negative trend vote on MAA for intravitreal pegcetacoplan for geographic atrophy (GA) after Dec 13 oral explanation.
- Apellis expects CHMP to adopt negative opinion at Jan 22-25, 2024 meeting.
- Company plans to appeal and seek re-examination of the opinion.
- Pegcetacoplan is for GA secondary to age-related macular degeneration.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1492422/000119312523294892/0001193125-23-294892-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1492422/000119312523294892/d863487d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-294892

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