secwatch.observer — SEC 8-K summary
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Issuer:     Akebia Therapeutics, Inc. (AKBA)
CIK:        0001517022
Form:       8-K
Filed at:   2022-11-03T23:59:59+00:00
Accession:  0001193125-22-276930
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Akebia Q3 Auryxia revenue up 14.9% to $42.2M; files FDA dispute for vadadustat
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- Net product revenue $42.2M (+14.9% YoY); total revenue $49.0M vs $48.8M YoY.
- Net loss $51.9M vs $59.5M YoY; cash $144.8M, sufficient for at least 12 months.
- Filed Formal Dispute Resolution Request with FDA over vadadustat CRL; response expected by end-2022.
- Retired $33M of Pharmakon debt; 2022 Auryxia revenue guidance reaffirmed at $170-175M.
- Assumed EU marketing application for vadadustat; EMA decision expected Q1 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1517022/000119312522276930/0001193125-22-276930-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1517022/000119312522276930/d402663d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-276930

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