Rezolute Phase 3 sunRIZE congenital HI misses endpoints; tumor HI EAP shows 75% IV dextrose discontinuation

Rezolute, Inc.

Phase 3 sunRIZE in congenital HI missed primary (hypoglycemia events) and key secondary endpoints; company cites strong placebo response and monitoring effect.
All 59 sunRIZE completers enrolled in open-label extension; 57 remain on ersodetug, durations up to ~18 months; some discontinued all other therapies.
Expanded Access Program in tumor HI: 6 of 8 (75%) patients on IV dextrose/TPN achieved complete discontinuation; 7 of 9 achieved 100% GIR reduction by 8 weeks.
Company plans to meet with FDA in Q1 2026 under Breakthrough Therapy to discuss congenital HI path forward.
Topline results from single-arm Phase 3 upLIFT study in tumor HI expected H2 2026.

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