---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-001556"
form_type: "8-K"
ticker: "RZLT"
cik: "0001509261"
company_name: "Rezolute, Inc."
filed_at: "2026-01-07T23:59:59+00:00"
generated_at: "2026-05-16T11:20:49.901023+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Rezolute Phase 3 sunRIZE congenital HI misses endpoints; tumor HI EAP shows 75% IV dextrose discontinuation

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-26-001556
- form_type: 8-K
- ticker: RZLT
- cik: 0001509261
- company_name: Rezolute, Inc.
- filed_at: 2026-01-07T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1509261/000110465926001556/0001104659-26-001556-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1509261/000110465926001556/tm262357d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-001556
- JSON: https://secwatch.observer/filing/0001104659-26-001556.json
- Plain text: https://secwatch.observer/filing/0001104659-26-001556.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.