{"schema_version":"secwatch.filing_event.v1","accession":"0001517022-23-000037","form_type":"8-K","ticker":"AKBA","cik":"0001517022","company_name":"Akebia Therapeutics, Inc.","filed_at":"2023-10-25T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.335732+00:00","generated_at":"2026-06-09T10:27:09.530249+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA accepts Akebia's resubmitted NDA for vadadustat; PDUFA date March 27, 2024","bullets":["Resubmission classified as class 2 response; six-month review period from resubmission date.","Post-marketing safety data from tens of thousands of Japanese patients included in the filing.","Vadadustat currently approved in 35 countries; Akebia preparing for commercial launch in H2 2024 if approved.","PDUFA goal date of March 27, 2024; resubmission addressed issues from prior complete response letter.","CEO expects availability shortly after approval, offering an oral alternative for anemia in dialysis patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001517022-23-000037","json":"https://secwatch.observer/filing/0001517022-23-000037.json","markdown":"https://secwatch.observer/filing/0001517022-23-000037.md","text":"https://secwatch.observer/filing/0001517022-23-000037.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1517022/000151702223000037/0001517022-23-000037-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1517022/000151702223000037/akba-20231025.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-09T10:27:09.530249+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"}