secwatch.observer — SEC 8-K summary ====================================== Issuer: Akebia Therapeutics, Inc. (AKBA) CIK: 0001517022 Form: 8-K Filed at: 2023-09-26T23:59:59+00:00 Accession: 0001628280-23-033033 Event type: regulatory Sentiment: neutral Materiality: 0.55 Item codes: 7.01, 9.01 LLM model: deepseek-v4-flash:cloud@v2 Akebia: Vafseo approved in Australia; Auryxia 2023 revenue guidance lowered to $170-175M -------------------------------------------------------------------------------- - Australia's TGA approved Vafseo (vadadustat) for anemia in dialysis patients; product now approved in 35 countries. - Akebia lowered Auryxia net product revenue guidance for 2023 to $170-175M from $175-180M due to market dynamics. - Company plans to resubmit U.S. NDA for vadadustat by end of Q3 2023. - Appointed Graham Ray (ex-Takeda) as VP, Key Accounts to lead U.S. launch prep and customer engagement. Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/1517022/000162828023033033/0001628280-23-033033-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/1517022/000162828023033033/akba-20230926.htm HTML page: https://secwatch.observer/filing/0001628280-23-033033 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer