{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-033592","form_type":"8-K","ticker":"RZLT","cik":"0001509261","company_name":"Rezolute, Inc.","filed_at":"2026-03-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.268611+00:00","generated_at":"2026-05-15T09:11:49.606676+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Rezolute provides FDA meeting update after Phase 3 HI trial missed primary endpoint","bullets":["sunRIZE Phase 3 ersodetug trial missed primary endpoint (SMBG hypoglycemia reduction); FDA acknowledged behavioral confounders.","FDA encouraged submission of study reports and analysis datasets for independent evaluation; company expects update in H2 2026.","Preliminary open-label extension data show continued glycemic improvement and reduction of background therapies.","Company believes FDA did not dismiss program; outcomes to be presented at upcoming scientific conference."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-033592","json":"https://secwatch.observer/filing/0001104659-26-033592.json","markdown":"https://secwatch.observer/filing/0001104659-26-033592.md","text":"https://secwatch.observer/filing/0001104659-26-033592.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1509261/000110465926033592/0001104659-26-033592-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1509261/000110465926033592/tm269642d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T09:11:49.606676+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"}