{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-25-102790","form_type":"8-K","ticker":"UNCY","cik":"0001766140","company_name":"Unicycive Therapeutics, Inc.","filed_at":"2025-10-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.364242+00:00","generated_at":"2026-05-17T01:58:04.131015+00:00","sec_items":["2.02","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Unicycive expects to resubmit OLC NDA by year-end after constructive FDA Type A meeting; cash $42M","bullets":["Cash and cash equivalents ~$42M as of Sept 30, 2025; runway into 2027 supports NDA resubmission, potential FDA approval, and launch.","FDA Type A meeting resolved single CRL deficiency re: third-party manufacturing vendor compliance; no other concerns identified.","Company plans to resubmit NDA for Oxylanthanum Carbonate (OLC) before year-end; potential PDUFA date in H1 2026.","FDA confirmed no issues with pre-clinical, clinical, or safety data submitted in original NDA."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-102790","json":"https://secwatch.observer/filing/0001213900-25-102790.json","markdown":"https://secwatch.observer/filing/0001213900-25-102790.md","text":"https://secwatch.observer/filing/0001213900-25-102790.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1766140/000121390025102790/0001213900-25-102790-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1766140/000121390025102790/ea0262723-8k_unicycive.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T01:58:04.131015+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"}