Rezolute Phase 3 in Congenital Hyperinsulinism Misses Endpoint

Rezolute (Nasdaq: RZLT) announced topline Phase 3 sunRIZE results in congenital hyperinsulinism on Dec 11, 2025. The study did not meet its primary endpoint assessing average weekly hypoglycemia events or its key secondary CGM endpoint.

At the top ersodetug dose (10 mg/kg) there was an approximate 45% reduction in hypoglycemia events versus a 40% improvement in placebo (not statistically significant). CGM time in hypoglycemia fell ~25% at 10 mg/kg versus a ~+5% increase with placebo. Target drug concentrations were achieved across ages. Safety was described as generally favorable; two participants had serious hypersensitivity leading to discontinuation. Rezolute intends to meet with FDA under its Breakthrough Therapy Designation; tumor HI study upLIFT topline expected H2 2026.

https://www.stocktitan.net/news/RZLT/rezolute-announces-phase-3-sun-rize-study-results-in-congenital-sbxc85fqkco2.html