{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-085614","form_type":"8-K","ticker":"RZLT","cik":"0001509261","company_name":"Rezolute, Inc.","filed_at":"2024-08-05T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.307850+00:00","generated_at":"2026-05-31T13:05:44.178607+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Rezolute receives FDA IND clearance for Phase 3 study of RZ358 in tumor hyperinsulinism","bullets":["FDA cleared IND for RZ358 (ersodetug) Phase 3 registrational trial treating hypoglycemia due to tumor HI.","Double-blind, placebo-controlled study of 24 participants; enrollment expected to start H1 2025.","Ongoing Phase 3 for congenital HI; topline data anticipated mid-2025.","Drug is a fully human monoclonal antibody binding to insulin receptor allosteric site.","Prior Expanded Access Program showed real-world benefit in tumor HI patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-085614","json":"https://secwatch.observer/filing/0001104659-24-085614.json","markdown":"https://secwatch.observer/filing/0001104659-24-085614.md","text":"https://secwatch.observer/filing/0001104659-24-085614.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/0001104659-24-085614-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T13:05:44.178607+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"}