{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-009180","form_type":"8-K","ticker":"RZLT","cik":"0001509261","company_name":"Rezolute, Inc.","filed_at":"2025-02-04T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.837981+00:00","generated_at":"2026-05-27T03:25:28.847755+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Rezolute DMC clears ersodetug open-label arm in infants; interim analysis expected Q1 2025","bullets":["DMC reviewed 8 infants (3mo-1yr) on 5/10 mg/kg bi-weekly/monthly: safe, target concentrations reached.","Infants may now enroll in double-blind placebo-controlled portion of sunRIZE Phase 3 study.","Enrollment completion expected Q2 2025 pending interim analysis; topline results Q4 2025 if no change.","Interim analysis end of Q1 2025; three outcomes: futility, continue as is, or increase sample size by 33% (18 pts).","If sample size increased, enrollment shifts to Q4 2025, topline results to mid-2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-009180","json":"https://secwatch.observer/filing/0001104659-25-009180.json","markdown":"https://secwatch.observer/filing/0001104659-25-009180.md","text":"https://secwatch.observer/filing/0001104659-25-009180.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1509261/000110465925009180/0001104659-25-009180-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1509261/000110465925009180/tm255467d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T03:25:28.847755+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"}