{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-23-034537","form_type":"8-K","ticker":"ARDX","cik":"0001437402","company_name":"ARDELYX, INC.","filed_at":"2023-10-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.078333+00:00","generated_at":"2026-06-09T21:47:19.231431+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Ardelyx announces FDA approval of XPHOZAH (tenapanor) for hyperphosphatemia in dialysis patients","bullets":["FDA approved XPHOZAH to reduce serum phosphorus in adults with CKD on dialysis as add-on therapy.","Indicated for patients with inadequate response to phosphate binders or intolerant of any dose.","XPHOZAH is a single tablet taken twice daily with a first-in-class mechanism blocking phosphate absorption.","Approval date: October 17, 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-23-034537","json":"https://secwatch.observer/filing/0001628280-23-034537.json","markdown":"https://secwatch.observer/filing/0001628280-23-034537.md","text":"https://secwatch.observer/filing/0001628280-23-034537.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1437402/000162828023034537/0001628280-23-034537-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1437402/000162828023034537/ardx-20231017.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-09T21:47:19.231431+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"}