{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-001666","form_type":"8-K","ticker":"RZLT","cik":"0001509261","company_name":"Rezolute, Inc.","filed_at":"2025-01-07T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.837567+00:00","generated_at":"2026-05-28T08:24:17.901277+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Rezolute (RZLT) gets FDA Breakthrough Therapy Designation for ersodetug in congenital hyperinsulinism","bullets":["FDA granted Breakthrough Therapy Designation to ersodetug (RZ358) for hypoglycemia due to congenital hyperinsulinism.","Designation based on Phase 2b (RIZE) study: ≥75% reduction in hypoglycemia, no clinically significant hyperglycemia.","Topline results from Phase 3 sunRIZE study expected H2 2025; U.S. sites enrolling after partial clinical hold lifted.","Company raised $73M in June 2024, extending cash runway into Q2 2026 to support clinical programs.","Also received ODD and IND clearance for tumor HI Phase 3 study, with topline results expected H2 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-001666","json":"https://secwatch.observer/filing/0001104659-25-001666.json","markdown":"https://secwatch.observer/filing/0001104659-25-001666.md","text":"https://secwatch.observer/filing/0001104659-25-001666.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1509261/000110465925001666/0001104659-25-001666-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1509261/000110465925001666/tm252102d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-28T08:24:17.901277+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"}