secwatch.observer — SEC 8-K summary
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Issuer:     Apellis Pharmaceuticals, Inc. (APLS)
CIK:        0001492422
Form:       8-K
Filed at:   2022-07-19T23:59:59+00:00
Accession:  0001193125-22-196599
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA grants Priority Review for Apellis' pegcetacoplan to treat geographic atrophy; PDUFA Nov 26, 2022
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- FDA accepted and granted Priority Review for intravitreal pegcetacoplan NDA for geographic atrophy (GA).
- PDUFA target action date set for November 26, 2022; no advisory committee meeting planned.
- Apellis plans to submit marketing authorization application to European Medicines Agency in H2 2022.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1492422/000119312522196599/0001193125-22-196599-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1492422/000119312522196599/d384280d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-196599

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