secwatch.observer — SEC 8-K summary
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Issuer:     Akebia Therapeutics, Inc. (AKBA)
CIK:        0001517022
Form:       8-K
Filed at:   2023-07-18T23:59:59+00:00
Accession:  0001517022-23-000019
Event type: regulatory
Sentiment:  neutral
Materiality: 0.55
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Akebia completes FDA Type A meeting; expects to resubmit vadadustat NDA by Q3 2023
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- Completed End of Dispute Type A meeting with FDA to align on NDA resubmission for vadadustat for anemia due to CKD in dialysis patients.
- Expects to receive FDA meeting minutes by mid-August 2023; resubmission planned by end of third quarter 2023.
- Upon NDA acceptance, expects PDUFA date six months from submission; vadadustat is approved in 34 countries including recent Swissmedic approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1517022/000151702223000019/0001517022-23-000019-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1517022/000151702223000019/akba-20230718.htm
  HTML page:      https://secwatch.observer/filing/0001517022-23-000019

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