{"schema_version":"secwatch.filing_event.v1","accession":"0001517022-23-000019","form_type":"8-K","ticker":"AKBA","cik":"0001517022","company_name":"Akebia Therapeutics, Inc.","filed_at":"2023-07-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:34.166859+00:00","generated_at":"2026-06-13T07:00:19.981144+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Akebia completes FDA Type A meeting; expects to resubmit vadadustat NDA by Q3 2023","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001517022-23-000019","json":"https://secwatch.observer/filing/0001517022-23-000019.json","markdown":"https://secwatch.observer/filing/0001517022-23-000019.md","text":"https://secwatch.observer/filing/0001517022-23-000019.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1517022/000151702223000019/0001517022-23-000019-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1517022/000151702223000019/akba-20230718.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T07:00:19.981144+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}