---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-109878"
form_type: "8-K"
ticker: "RZLT"
cik: "0001509261"
company_name: "Rezolute, Inc."
filed_at: "2023-10-18T23:59:59+00:00"
generated_at: "2026-06-09T21:48:32.160849+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.72
calibrated_materiality_score: 0.72
confidence: "high"
source: SEC EDGAR
---

# Rezolute receives EMA PRIME eligibility for RZ358 in congenital hyperinsulinism

## Summary
- EMA grants PRIME eligibility to RZ358 for congenital HI, citing unmet medical need and positive Phase 2b data.
- PRIME provides enhanced regulatory support to accelerate development and evaluation.
- Phase 3 study for RZ358 planned to initiate in Q4 2023.
- Phase 2b RIZE study showed ~75% average improvement in hypoglycemia at intended Phase 3 doses.
- Improvement was consistent across age groups (2-6, 6-12, >12 years).

## SEC filing metadata
- accession: 0001104659-23-109878
- form_type: 8-K
- ticker: RZLT
- cik: 0001509261
- company_name: Rezolute, Inc.
- filed_at: 2023-10-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.72
- calibrated_materiality_score: 0.72
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1509261/000110465923109878/0001104659-23-109878-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1509261/000110465923109878/tm2328622d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-109878
- JSON: https://secwatch.observer/filing/0001104659-23-109878.json
- Plain text: https://secwatch.observer/filing/0001104659-23-109878.txt

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