---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-037746"
form_type: "8-K"
ticker: "RZLT"
cik: "0001509261"
company_name: "Rezolute, Inc."
filed_at: "2025-04-23T23:59:59+00:00"
generated_at: "2026-05-23T08:02:38.535996+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Rezolute's Phase 3 sunRIZE study of ersodetug gets positive DMC recommendation; enrollment May, data Dec 2025

## Summary
- Independent DMC recommends continuation of sunRIZE study as planned; no need to increase sample size.
- Enrollment expected to complete in May 2025; topline data anticipated in December 2025.
- U.S. sites now activated and enrolling; global study across more than a dozen countries.
- Interim analysis evaluated primary endpoint of hypoglycemia events after ~50% of patients completed assessments.
- Rezolute remains blinded to interim data; DMC recommendation based on pre-specified futility and sample size assessment.

## SEC filing metadata
- accession: 0001104659-25-037746
- form_type: 8-K
- ticker: RZLT
- cik: 0001509261
- company_name: Rezolute, Inc.
- filed_at: 2025-04-23T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1509261/000110465925037746/0001104659-25-037746-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1509261/000110465925037746/tm2512716d2_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-037746
- JSON: https://secwatch.observer/filing/0001104659-25-037746.json
- Plain text: https://secwatch.observer/filing/0001104659-25-037746.txt

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