{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-126502","form_type":"8-K","ticker":"RZLT","cik":"0001509261","company_name":"Rezolute, Inc.","filed_at":"2026-11-13T11:27:13+00:00","discovered_at":"2026-11-13T11:30:00.344506+00:00","generated_at":"2026-11-13T11:30:02.307050+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Rezolute's Phase 3 upLIFT study of ersodetug in tumor hyperinsulinism hits primary endpoint","bullets":["13 of 16 participants met the ≥50% GIR reduction responder criterion, including 12 with complete IV glucose discontinuation; threshold was ≥9 responders (≥56%).","Primary endpoint achievement based on preliminary results from a November 5, 2026 data evaluation; topline and statistical analysis expected by mid-December 2026.","One participant discontinued early to enter home hospice and died a week later from cancer progression; classified as a non-responder.","Enrollment: 16 participants — 4 with non-islet cell tumors and 12 with insulin-secreting malignant insulinomas; ersodetug dosed 9 mg/kg weekly for 8 weeks.","Ersodetug well-tolerated with no drug-related safety findings; CEO Nevan Elam targets FDA discussions in Q1 2027 for congenital and tumor HI."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-126502","json":"https://secwatch.observer/filing/0001104659-26-126502.json","markdown":"https://secwatch.observer/filing/0001104659-26-126502.md","text":"https://secwatch.observer/filing/0001104659-26-126502.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1509261/000110465926126502/0001104659-26-126502-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1509261/000110465926126502/tm2627558d10_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-11-13T11:30:02.307050+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"}