{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-054943","form_type":"8-K","ticker":"RZLT","cik":"0001509261","company_name":"Rezolute, Inc.","filed_at":"2026-05-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.390500+00:00","generated_at":"2026-05-14T23:53:01.300462+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Rezolute sunRIZE Phase 3 misses primary endpoint; CGM analyses show nominal hypoglycemia reduction","bullets":["Primary endpoint (hypoglycemia events by SMBG) not met; secondary CGM endpoint not statistically significant at Week 24/EOT.","CGM analyses showed nominal significance: >50% reduction in time-in-hypoglycemia (FAS), ~60-80% (PPS) vs placebo across timepoints.","OLE: all 59 completers enrolled, 57 continue; up to 24 months exposure; reduced background SOC, many on ersodetug monotherapy.","FDA Type B meeting (Mar 17, 2026) acknowledged primary endpoint challenges; requested comprehensive data submission to inform next steps.","Company believes data show target engagement and therapeutic potential; seeking alignment with FDA on path to approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-054943","json":"https://secwatch.observer/filing/0001104659-26-054943.json","markdown":"https://secwatch.observer/filing/0001104659-26-054943.md","text":"https://secwatch.observer/filing/0001104659-26-054943.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1509261/000110465926054943/0001104659-26-054943-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1509261/000110465926054943/tm2613408d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-14T23:53:01.300462+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"}