{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-097969","form_type":"8-K","ticker":"RZLT","cik":"0001509261","company_name":"Rezolute, Inc.","filed_at":"2024-09-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.308202+00:00","generated_at":"2026-05-31T05:53:43.143242+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":"FDA lifts partial clinical holds on Rezolute's RZ358 for congenital hyperinsulinism","bullets":["FDA removed partial clinical holds on RZ358 (ersodetug) for hypoglycemia in congenital HI; U.S. enrollment in global Phase 3 sunRIZE study now permitted.","FDA concluded liver toxicity in Sprague Dawley rats is strain-specific and not relevant to humans.","Company expects to begin U.S. participant enrollment in early 2025; topline data from sunRIZE study anticipated in H2 2025.","This follows prior FDA clearance of a separate Phase 3 study in tumor-associated HI, advancing ersodetug in two rare disease programs."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-097969","json":"https://secwatch.observer/filing/0001104659-24-097969.json","markdown":"https://secwatch.observer/filing/0001104659-24-097969.md","text":"https://secwatch.observer/filing/0001104659-24-097969.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1509261/000110465924097969/0001104659-24-097969-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1509261/000110465924097969/tm2420844d2_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T05:53:43.143242+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"}