{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-037746","form_type":"8-K","ticker":"RZLT","cik":"0001509261","company_name":"Rezolute, Inc.","filed_at":"2025-04-23T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.538334+00:00","generated_at":"2026-05-23T08:02:38.535996+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Rezolute's Phase 3 sunRIZE study of ersodetug gets positive DMC recommendation; enrollment May, data Dec 2025","bullets":["Independent DMC recommends continuation of sunRIZE study as planned; no need to increase sample size.","Enrollment expected to complete in May 2025; topline data anticipated in December 2025.","U.S. sites now activated and enrolling; global study across more than a dozen countries.","Interim analysis evaluated primary endpoint of hypoglycemia events after ~50% of patients completed assessments.","Rezolute remains blinded to interim data; DMC recommendation based on pre-specified futility and sample size assessment."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-037746","json":"https://secwatch.observer/filing/0001104659-25-037746.json","markdown":"https://secwatch.observer/filing/0001104659-25-037746.md","text":"https://secwatch.observer/filing/0001104659-25-037746.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1509261/000110465925037746/0001104659-25-037746-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1509261/000110465925037746/tm2512716d2_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T08:02:38.535996+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"}