{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-001556","form_type":"8-K","ticker":"RZLT","cik":"0001509261","company_name":"Rezolute, Inc.","filed_at":"2026-01-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.268100+00:00","generated_at":"2026-05-16T11:20:49.901023+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Rezolute Phase 3 sunRIZE congenital HI misses endpoints; tumor HI EAP shows 75% IV dextrose discontinuation","bullets":["Phase 3 sunRIZE in congenital HI missed primary (hypoglycemia events) and key secondary endpoints; company cites strong placebo response and monitoring effect.","All 59 sunRIZE completers enrolled in open-label extension; 57 remain on ersodetug, durations up to ~18 months; some discontinued all other therapies.","Expanded Access Program in tumor HI: 6 of 8 (75%) patients on IV dextrose/TPN achieved complete discontinuation; 7 of 9 achieved 100% GIR reduction by 8 weeks.","Company plans to meet with FDA in Q1 2026 under Breakthrough Therapy to discuss congenital HI path forward.","Topline results from single-arm Phase 3 upLIFT study in tumor HI expected H2 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-001556","json":"https://secwatch.observer/filing/0001104659-26-001556.json","markdown":"https://secwatch.observer/filing/0001104659-26-001556.md","text":"https://secwatch.observer/filing/0001104659-26-001556.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1509261/000110465926001556/0001104659-26-001556-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1509261/000110465926001556/tm262357d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:20:49.901023+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"}