Rezolute presents plans for 2027 ersodetug BLA filing in congenital hyperinsulinism
RZLT•Rezolute said its Phase 3 sunRIZE trial of ersodetug missed its primary endpoint for reducing weekly hypoglycemia events in congenital hyperinsulinism, and it is targeting a 2027 biologics license application. The company reported $108 million in cash, funding through the first quarter of 2028, and expects topline tumor hyperinsulinism program data in December 2026.
1. Trial results and plans
Rezolute said its Phase 3 sunRIZE trial of ersodetug missed its primary endpoint for reducing weekly hypoglycemia events in congenital hyperinsulinism. Continuous glucose monitoring showed clinically meaningful reductions, but time in hypoglycemia was not statistically significant at week 24. The FDA encouraged a pre-BLA meeting request, and Rezolute is targeting a 2027 biologics license application for congenital hyperinsulinism.
2. Cash and upcoming data
Rezolute reported $108 million in cash, which it said provides funding through the first quarter of 2028. Topline data from its tumor hyperinsulinism program are expected in December 2026.
