---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-097969"
form_type: "8-K"
ticker: "RZLT"
cik: "0001509261"
company_name: "Rezolute, Inc."
filed_at: "2024-09-09T23:59:59+00:00"
generated_at: "2026-05-31T05:53:43.143242+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA lifts partial clinical holds on Rezolute's RZ358 for congenital hyperinsulinism

## Summary
- FDA removed partial clinical holds on RZ358 (ersodetug) for hypoglycemia in congenital HI; U.S. enrollment in global Phase 3 sunRIZE study now permitted.
- FDA concluded liver toxicity in Sprague Dawley rats is strain-specific and not relevant to humans.
- Company expects to begin U.S. participant enrollment in early 2025; topline data from sunRIZE study anticipated in H2 2025.
- This follows prior FDA clearance of a separate Phase 3 study in tumor-associated HI, advancing ersodetug in two rare disease programs.

## SEC filing metadata
- accession: 0001104659-24-097969
- form_type: 8-K
- ticker: RZLT
- cik: 0001509261
- company_name: Rezolute, Inc.
- filed_at: 2024-09-09T23:59:59+00:00
- event_type: regulatory
- 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/1509261/000110465924097969/0001104659-24-097969-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1509261/000110465924097969/tm2420844d2_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-097969
- JSON: https://secwatch.observer/filing/0001104659-24-097969.json
- Plain text: https://secwatch.observer/filing/0001104659-24-097969.txt

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