---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-085892"
form_type: "8-K"
ticker: "RZLT"
cik: "0001509261"
company_name: "Rezolute, Inc."
filed_at: "2025-09-02T23:59:59+00:00"
generated_at: "2026-05-17T08:50:27.228099+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Rezolute gains FDA alignment on streamlined Phase 3 trial design for ersodetug in tumor HI

## Summary
- FDA agreed to remove double-blind placebo-controlled requirement; study now open-label, single-arm.
- Phase 3 upLIFT trial will enroll as few as 16 patients with tumor hyperinsulinism (HI).
- Topline data from upLIFT expected in the second half of 2026.
- FDA confirmed that the pivotal sunRIZE trial in congenital HI (topline Dec 2025) serves as confirmatory evidence.
- FDA meeting held August 19, 2025; simplified path based on Expanded Access Program outcomes in over 10 patients.

## SEC filing metadata
- accession: 0001104659-25-085892
- form_type: 8-K
- ticker: RZLT
- cik: 0001509261
- company_name: Rezolute, Inc.
- filed_at: 2025-09-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1509261/000110465925085892/0001104659-25-085892-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1509261/000110465925085892/tm2524786d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-085892
- JSON: https://secwatch.observer/filing/0001104659-25-085892.json
- Plain text: https://secwatch.observer/filing/0001104659-25-085892.txt

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