{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-23-053035","form_type":"8-K","ticker":"UNCY","cik":"0001766140","company_name":"Unicycive Therapeutics, Inc.","filed_at":"2023-06-30T23:59:59+00:00","discovered_at":"2026-05-14T18:03:40.455346+00:00","generated_at":"2026-06-13T14:12:42.183402+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Unicycive receives FDA request for additional data on LDC NDA; timeline extended","bullets":["FDA asked for risk assessment and clinical data to evaluate tolerability of lanthanum dioxycarbonate in dialysis patients.","Pre-NDA meeting revealed quantitative differences in GI adverse findings between LDC and lanthanum carbonate.","Company plans follow-up meeting with FDA and expects further updates in Q3 2023.","Bioequivalence to Fosrenol was previously established in Phase I studies; no GI neoplasms seen in mouse study.","LDC targets hyperphosphatemia in CKD dialysis patients; global market opportunity >$2.5B in 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-23-053035","json":"https://secwatch.observer/filing/0001213900-23-053035.json","markdown":"https://secwatch.observer/filing/0001213900-23-053035.md","text":"https://secwatch.observer/filing/0001213900-23-053035.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1766140/000121390023053035/0001213900-23-053035-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1766140/000121390023053035/ea181168-8k_unicycive.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T14:12:42.183402+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"}