{"schema_version":"secwatch.filing_event.v1","accession":"0001013762-23-005659","form_type":"8-K","ticker":"UNCY","cik":"0001766140","company_name":"Unicycive Therapeutics, Inc.","filed_at":"2023-10-23T23:59:59+00:00","discovered_at":"2026-05-14T18:03:30.355760+00:00","generated_at":"2026-06-09T17:01:26.026547+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Unicycive reaches FDA alignment on NDA path for OLC; pivotal trial to start by end of 2023","bullets":["FDA agreed on full NDA package requirements: clinical, preclinical, and CMC data for Oxylanthanum Carbonate (OLC).","Pivotal open-label trial to enroll 60 CKD dialysis patients; 4-week evaluation after dose titration.","Top-line data expected Q2 2024; no statistical analysis required; efficacy referenced from prior bioequivalence study.","Cash of $18.8M as of June 30, 2023 expected to fund trial and operations into H2 2024.","NDA to be filed via 505(b)(2) pathway referencing Fosrenol; only one clinical study required."],"urls":{"canonical":"https://secwatch.observer/filing/0001013762-23-005659","json":"https://secwatch.observer/filing/0001013762-23-005659.json","markdown":"https://secwatch.observer/filing/0001013762-23-005659.md","text":"https://secwatch.observer/filing/0001013762-23-005659.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1766140/000101376223005659/0001013762-23-005659-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1766140/000101376223005659/ea187125-8k_unicycive.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-09T17:01:26.026547+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"}