{"schema_version":"secwatch.filing_event.v1","accession":"0001517022-24-000031","form_type":"8-K","ticker":"AKBA","cik":"0001517022","company_name":"Akebia Therapeutics, Inc.","filed_at":"2024-03-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:24.462032+00:00","generated_at":"2026-06-04T06:05:17.991502+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Akebia Therapeutics receives FDA approval for Vafseo (vadadustat) for dialysis patients","bullets":["FDA approved Vafseo for anemia due to CKD in adults on dialysis ≥3 months; boxed warning for thrombosis risks.","Vafseo is a once-daily oral HIF-PH inhibitor; already approved in 37 countries.","~500,000 U.S. adult dialysis patients suffer from CKD anemia.","Approval based on INNO2VATE Phase 3 program data published in NEJM 2021; plus Japan post-marketing data.","Akebia plans U.S. launch with commercial team and CSL Vifor partnership; conference call March 28."],"urls":{"canonical":"https://secwatch.observer/filing/0001517022-24-000031","json":"https://secwatch.observer/filing/0001517022-24-000031.json","markdown":"https://secwatch.observer/filing/0001517022-24-000031.md","text":"https://secwatch.observer/filing/0001517022-24-000031.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1517022/000151702224000031/0001517022-24-000031-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1517022/000151702224000031/akba-20240327.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T06:05:17.991502+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"}