---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-001666"
form_type: "8-K"
ticker: "RZLT"
cik: "0001509261"
company_name: "Rezolute, Inc."
filed_at: "2025-01-07T23:59:59+00:00"
generated_at: "2026-05-28T08:24:17.901277+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Rezolute (RZLT) gets FDA Breakthrough Therapy Designation for ersodetug in congenital hyperinsulinism

## Summary
- FDA granted Breakthrough Therapy Designation to ersodetug (RZ358) for hypoglycemia due to congenital hyperinsulinism.
- Designation based on Phase 2b (RIZE) study: ≥75% reduction in hypoglycemia, no clinically significant hyperglycemia.
- Topline results from Phase 3 sunRIZE study expected H2 2025; U.S. sites enrolling after partial clinical hold lifted.
- Company raised $73M in June 2024, extending cash runway into Q2 2026 to support clinical programs.
- Also received ODD and IND clearance for tumor HI Phase 3 study, with topline results expected H2 2026.

## SEC filing metadata
- accession: 0001104659-25-001666
- form_type: 8-K
- ticker: RZLT
- cik: 0001509261
- company_name: Rezolute, Inc.
- filed_at: 2025-01-07T23:59:59+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/1509261/000110465925001666/0001104659-25-001666-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1509261/000110465925001666/tm252102d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-001666
- JSON: https://secwatch.observer/filing/0001104659-25-001666.json
- Plain text: https://secwatch.observer/filing/0001104659-25-001666.txt

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