---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-033068"
form_type: "8-K"
ticker: "RZLT"
cik: "0001509261"
company_name: "Rezolute, Inc."
filed_at: "2024-03-11T23:59:59+00:00"
generated_at: "2026-06-04T23:46:28.557040+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Rezolute validates RZ358 for NICTH, doubling addressable tumor HI patient population

## Summary
- Preclinical study shows RZ358 blunts IGF-2 and insulin-mediated signaling at clinically relevant levels.
- Total addressable US market for tumor HI est. at ~4,500 patients (1,500 ICTH + 3,000 NICTH).
- Company evaluating registrational study in tumor HI including both ICTH and NICTH after positive Jan 2024 FDA interaction.
- RZ358 already in Phase 3 for congenital HI; has Orphan Drug Designations in US/EU for multiple indications.

## SEC filing metadata
- accession: 0001104659-24-033068
- form_type: 8-K
- ticker: RZLT
- cik: 0001509261
- company_name: Rezolute, Inc.
- filed_at: 2024-03-11T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1509261/000110465924033068/0001104659-24-033068-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1509261/000110465924033068/tm248506d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-033068
- JSON: https://secwatch.observer/filing/0001104659-24-033068.json
- Plain text: https://secwatch.observer/filing/0001104659-24-033068.txt

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