{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-24-096104","form_type":"8-K","ticker":"UNCY","cik":"0001766140","company_name":"Unicycive Therapeutics, Inc.","filed_at":"2024-11-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.524744+00:00","generated_at":"2026-05-30T02:04:54.757987+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA accepts Unicycive's NDA for Oxylanthanum Carbonate; PDUFA date June 28, 2025","bullets":["FDA accepted NDA for OLC to treat hyperphosphatemia in CKD patients on dialysis.","PDUFA target action date set for June 28, 2025; company preparing for commercial launch in H2 2025.","FDA granted a waiver for the NDA application PDUFA fees, saving approximately $4 million.","OLC aims to reduce pill burden vs. current options (up to 12 pills/day); pills are swallowed, not chewed."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-24-096104","json":"https://secwatch.observer/filing/0001213900-24-096104.json","markdown":"https://secwatch.observer/filing/0001213900-24-096104.md","text":"https://secwatch.observer/filing/0001213900-24-096104.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1766140/000121390024096104/0001213900-24-096104-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1766140/000121390024096104/ea0220621-8k_unicycive.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T02:04:54.757987+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"}