{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-24-055436","form_type":"8-K","ticker":"UNCY","cik":"0001766140","company_name":"Unicycive Therapeutics, Inc.","filed_at":"2024-06-25T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.965870+00:00","generated_at":"2026-06-01T02:14:13.170212+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Unicycive OLC pivotal trial meets primary endpoint; NDA submission planned Q3 2024","bullets":["Primary endpoint achieved: only 1.4% treatment-related discontinuation in evaluable population (n=71), vs 14% for Fosrenol.","Secondary safety endpoint: no treatment-related SAEs; most AEs mild-moderate; diarrhea (9%) and vomiting (6%) most common.","After washout, 90% of safety population (77/86) achieved phosphate ≤5.5 mg/dL at end of titration with OLC.","NDA submission via 505(b)(2) pathway anticipated Q3 2024, supported by bioequivalence and preclinical data.","Study enrolled 106 patients; OLC demonstrated tolerability at clinically effective doses (up to 3000 mg/day)."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-24-055436","json":"https://secwatch.observer/filing/0001213900-24-055436.json","markdown":"https://secwatch.observer/filing/0001213900-24-055436.md","text":"https://secwatch.observer/filing/0001213900-24-055436.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1766140/000121390024055436/0001213900-24-055436-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1766140/000121390024055436/ea0208437-8k_unicycive.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T02:14:13.170212+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"}