{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-068804","form_type":"8-K","ticker":"RZLT","cik":"0001509261","company_name":"Rezolute, Inc.","filed_at":"2025-07-18T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.168692+00:00","generated_at":"2026-05-18T05:39:42.815986+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Rezolute fully enrolls Phase 3 sunRIZE study of ersodetug; topline data expected by end of 2025","bullets":["63 participants enrolled (8 open-label infants, 55 double-blind); DMC recommended continuing with original sample size after interim analysis.","Baseline hypoglycemia burden severe: mean 15 events/week (SMBG), 19% time <70 mg/dL (CGM); 51% hospitalized in past year.","76% of participants have kATP channel mutations (typically diazoxide non-responsive); 19% on 2+ medical therapies, 40% on enteral feeding.","29% experienced severe hypoglycemia with loss of consciousness requiring emergency intervention in past year.","Topline safety and efficacy results from pivotal 24-week treatment period anticipated by end of 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-068804","json":"https://secwatch.observer/filing/0001104659-25-068804.json","markdown":"https://secwatch.observer/filing/0001104659-25-068804.md","text":"https://secwatch.observer/filing/0001104659-25-068804.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1509261/000110465925068804/0001104659-25-068804-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1509261/000110465925068804/tm2521194d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T05:39:42.815986+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"}