{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-115874","form_type":"8-K","ticker":"RZLT","cik":"0001509261","company_name":"Rezolute, Inc.","filed_at":"2026-10-14T21:11:48+00:00","discovered_at":"2026-10-14T21:12:02.299623+00:00","generated_at":"2026-10-14T21:12:05.752767+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Rezolute completes Phase 3 upLIFT enrollment; topline ersodetug data expected mid-December 2026","bullets":["Phase 3 upLIFT fully enrolled 16 participants with insulinoma or non-islet cell tumors causing uncontrolled hypoglycemia; topline results expected mid-December 2026.","Primary endpoint: at least 50% reduction from baseline in IV glucose infusion rate; responder rate must be at least 56% (95% CI 30-80%) for significance.","7 of the first 8 participants met the responder criterion and all 7 fully discontinued IV glucose; the eighth entered hospice and died of cancer progression, counted as a non-responder.","Ersodetug given at 9 mg/kg weekly for 8 weeks as add-on to standard of care; well-tolerated with no drug-related safety findings reported to date.","Company continues expanded access for compassionate use in tumor HI and sees potential to advance both indications in 2027 if outcomes are favorable."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-115874","json":"https://secwatch.observer/filing/0001104659-26-115874.json","markdown":"https://secwatch.observer/filing/0001104659-26-115874.md","text":"https://secwatch.observer/filing/0001104659-26-115874.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1509261/000110465926115874/0001104659-26-115874-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1509261/000110465926115874/tm2627620d1_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-14T21:12:05.752767+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"}