{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-126021","form_type":"8-K","ticker":"RZLT","cik":"0001509261","company_name":"Rezolute, Inc.","filed_at":"2023-12-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.309595+00:00","generated_at":"2026-06-07T12:47:02.258122+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 completes Phase 2 DME enrollment, initiates Phase 3 for congenital hyperinsulinism","bullets":["Phase 2 study of oral RZ402 for diabetic macular edema enrolled ~95 participants; topline data expected mid-Q2 2024.","Phase 3 sunRIZE study of RZ358 for congenital hyperinsulinism initiated; first clinical site activated outside US.","Phase 3 to enroll up to 56 patients at ~20 centers in >12 countries; topline results anticipated mid-2025.","RZ358 previously received EMA PRIME designation in October 2023 for congenital hyperinsulinism."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-126021","json":"https://secwatch.observer/filing/0001104659-23-126021.json","markdown":"https://secwatch.observer/filing/0001104659-23-126021.md","text":"https://secwatch.observer/filing/0001104659-23-126021.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1509261/000110465923126021/0001104659-23-126021-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1509261/000110465923126021/tm2332663d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T12:47:02.258122+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"}