---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-068804"
form_type: "8-K"
ticker: "RZLT"
cik: "0001509261"
company_name: "Rezolute, Inc."
filed_at: "2025-07-18T23:59:59+00:00"
generated_at: "2026-05-18T05:39:42.815986+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Rezolute fully enrolls Phase 3 sunRIZE study of ersodetug; topline data expected by end of 2025

## Summary
- 63 participants enrolled (8 open-label infants, 55 double-blind); DMC recommended continuing with original sample size after interim analysis.
- Baseline hypoglycemia burden severe: mean 15 events/week (SMBG), 19% time <70 mg/dL (CGM); 51% hospitalized in past year.
- 76% of participants have kATP channel mutations (typically diazoxide non-responsive); 19% on 2+ medical therapies, 40% on enteral feeding.
- 29% experienced severe hypoglycemia with loss of consciousness requiring emergency intervention in past year.
- Topline safety and efficacy results from pivotal 24-week treatment period anticipated by end of 2025.

## SEC filing metadata
- accession: 0001104659-25-068804
- form_type: 8-K
- ticker: RZLT
- cik: 0001509261
- company_name: Rezolute, Inc.
- filed_at: 2025-07-18T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1509261/000110465925068804/0001104659-25-068804-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1509261/000110465925068804/tm2521194d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-068804
- JSON: https://secwatch.observer/filing/0001104659-25-068804.json
- Plain text: https://secwatch.observer/filing/0001104659-25-068804.txt

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