{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-109878","form_type":"8-K","ticker":"RZLT","cik":"0001509261","company_name":"Rezolute, Inc.","filed_at":"2023-10-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.309002+00:00","generated_at":"2026-06-09T21:48:32.160849+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.72,"calibrated_materiality_score":0.72,"confidence":"high","headline":"Rezolute receives EMA PRIME eligibility for RZ358 in congenital hyperinsulinism","bullets":["EMA grants PRIME eligibility to RZ358 for congenital HI, citing unmet medical need and positive Phase 2b data.","PRIME provides enhanced regulatory support to accelerate development and evaluation.","Phase 3 study for RZ358 planned to initiate in Q4 2023.","Phase 2b RIZE study showed ~75% average improvement in hypoglycemia at intended Phase 3 doses.","Improvement was consistent across age groups (2-6, 6-12, >12 years)."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-109878","json":"https://secwatch.observer/filing/0001104659-23-109878.json","markdown":"https://secwatch.observer/filing/0001104659-23-109878.md","text":"https://secwatch.observer/filing/0001104659-23-109878.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1509261/000110465923109878/0001104659-23-109878-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1509261/000110465923109878/tm2328622d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-09T21:48:32.160849+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"}