{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-25-059303","form_type":"8-K","ticker":"UNCY","cik":"0001766140","company_name":"Unicycive Therapeutics, Inc.","filed_at":"2025-06-30T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.629985+00:00","generated_at":"2026-05-18T13:47:46.018436+00:00","sec_items":["2.02","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA issues Complete Response Letter for Unicycive's oxylanthanum carbonate NDA; company plans Type A meeting","bullets":["CRL cites deficiencies at third-party manufacturing vendor unrelated to OLC drug; no clinical or safety concerns.","Second manufacturing vendor already produced OLC drug product; may resolve CMC issues identified in CRL.","Unicycive plans to immediately request a Type A meeting with FDA to align on next steps.","Preliminary unaudited cash ~$20.7M as of June 30, 2025; cash runway expected into H2 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-059303","json":"https://secwatch.observer/filing/0001213900-25-059303.json","markdown":"https://secwatch.observer/filing/0001213900-25-059303.md","text":"https://secwatch.observer/filing/0001213900-25-059303.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1766140/000121390025059303/0001213900-25-059303-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1766140/000121390025059303/ea0247469-8k_unicycive.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T13:47:46.018436+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"}