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

Issuer:     Apellis Pharmaceuticals, Inc. (APLS)
CIK:        0001492422
Form:       8-K
Filed at:   2023-03-15T23:59:59+00:00
Accession:  0001193125-23-071396
Event type: regulatory
Sentiment:  negative
Materiality: 0.60
Item codes: 7.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA extends PDUFA goal date for Apellis' EMPAVELI Injector sNDA
---------------------------------------------------------------

- FDA notified Apellis on March 14, 2023 that labeling review is ongoing and the March 15, 2023 PDUFA goal date will be missed.
- New PDUFA goal date for the EMPAVELI Injector (for PNH self-administration) has not yet been determined.
- EMPAVELI (pegcetacoplan) is currently approved for adults with paroxysmal nocturnal hemoglobinuria.
- The injector is an on-body device designed to enhance self-administration of EMPAVELI.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1492422/000119312523071396/0001193125-23-071396-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1492422/000119312523071396/d377141d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-071396

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