{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-113503","form_type":"8-K","ticker":"RZLT","cik":"0001509261","company_name":"Rezolute, Inc.","filed_at":"2026-10-05T12:00:15+00:00","discovered_at":"2026-10-05T12:05:00.290216+00:00","generated_at":"2026-10-12T14:44:25.720280+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Rezolute: FDA recommends pre-BLA meeting for ersodetug in congenital HI despite sunRIZE missing primary endpoint","bullets":["FDA recommended a Type B pre-BLA meeting as a precursor to a BLA for ersodetug in congenital hyperinsulinism, after reviewing data Rezolute submitted in June 2026.","sunRIZE Phase 3 missed its primary endpoint: finger-stick SMBG hypoglycemia event reductions were not statistically significant vs placebo; key CGM secondary endpoint at Week 24 also not met.","FDA explicitly did not opine on approvability of ersodetug for congenital HI, noting any determination would only come during a formal BLA review.","Topline results from the Phase 3 upLIFT study in tumor HI are expected this quarter; Rezolute will then evaluate BLA strategy for potentially both programs.","sunRIZE open-label extension ongoing with high retention; ersodetug treatment duration ranges ~9 months to over 2 years, with continued glycemic control and reduced background standard of care."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-113503","json":"https://secwatch.observer/filing/0001104659-26-113503.json","markdown":"https://secwatch.observer/filing/0001104659-26-113503.md","text":"https://secwatch.observer/filing/0001104659-26-113503.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1509261/000110465926113503/0001104659-26-113503-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1509261/000110465926113503/tm2626976d1_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T14:44:25.720280+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"}