---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-054943"
form_type: "8-K"
ticker: "RZLT"
cik: "0001509261"
company_name: "Rezolute, Inc."
filed_at: "2026-05-04T23:59:59+00:00"
generated_at: "2026-05-14T23:53:01.300462+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Rezolute sunRIZE Phase 3 misses primary endpoint; CGM analyses show nominal hypoglycemia reduction

## Summary
- Primary endpoint (hypoglycemia events by SMBG) not met; secondary CGM endpoint not statistically significant at Week 24/EOT.
- CGM analyses showed nominal significance: >50% reduction in time-in-hypoglycemia (FAS), ~60-80% (PPS) vs placebo across timepoints.
- OLE: all 59 completers enrolled, 57 continue; up to 24 months exposure; reduced background SOC, many on ersodetug monotherapy.
- FDA Type B meeting (Mar 17, 2026) acknowledged primary endpoint challenges; requested comprehensive data submission to inform next steps.
- Company believes data show target engagement and therapeutic potential; seeking alignment with FDA on path to approval.

## SEC filing metadata
- accession: 0001104659-26-054943
- form_type: 8-K
- ticker: RZLT
- cik: 0001509261
- company_name: Rezolute, Inc.
- filed_at: 2026-05-04T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1509261/000110465926054943/0001104659-26-054943-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1509261/000110465926054943/tm2613408d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-054943
- JSON: https://secwatch.observer/filing/0001104659-26-054943.json
- Plain text: https://secwatch.observer/filing/0001104659-26-054943.txt

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