{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-23-018655","form_type":"8-K","ticker":"ARDX","cik":"0001437402","company_name":"ARDELYX, INC.","filed_at":"2023-05-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:38.869360+00:00","generated_at":"2026-06-14T22:16:57.369279+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Ardelyx FDA accepts XPHOZAH resubmission; PDUFA Oct 17, 2023","bullets":["FDA accepted resubmission of NDA for XPHOZAH (tenapanor) for serum phosphate control in dialysis patients.","FDA designated class 2 review with six-month review period; user fee goal date October 17, 2023.","Ardelyx expects XPHOZAH to be commercially available in Q4 2023 following potential FDA approval.","NDA supported by over 1,200 patients in Phase 3 trials (PHREEDOM, BLOCK, AMPLIFY) that met primary endpoints."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-23-018655","json":"https://secwatch.observer/filing/0001628280-23-018655.json","markdown":"https://secwatch.observer/filing/0001628280-23-018655.md","text":"https://secwatch.observer/filing/0001628280-23-018655.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1437402/000162828023018655/0001628280-23-018655-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1437402/000162828023018655/ardx-20230517.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-14T22:16:57.369279+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"}