secwatch.observer — SEC 8-K summary
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Issuer:     Rezolute, Inc. (RZLT)
CIK:        0001509261
Form:       8-K
Filed at:   2026-01-07T23:59:59+00:00
Accession:  0001104659-26-001556
Event type: other_material
Sentiment:  negative
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Rezolute Phase 3 sunRIZE congenital HI misses endpoints; tumor HI EAP shows 75% IV dextrose discontinuation
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- Phase 3 sunRIZE in congenital HI missed primary (hypoglycemia events) and key secondary endpoints; company cites strong placebo response and monitoring effect.
- All 59 sunRIZE completers enrolled in open-label extension; 57 remain on ersodetug, durations up to ~18 months; some discontinued all other therapies.
- Expanded Access Program in tumor HI: 6 of 8 (75%) patients on IV dextrose/TPN achieved complete discontinuation; 7 of 9 achieved 100% GIR reduction by 8 weeks.
- Company plans to meet with FDA in Q1 2026 under Breakthrough Therapy to discuss congenital HI path forward.
- Topline results from single-arm Phase 3 upLIFT study in tumor HI expected H2 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1509261/000110465926001556/0001104659-26-001556-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1509261/000110465926001556/tm262357d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-001556

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer