Rezolute announced expanded analyses from its Phase 3 sunRIZE study of ersodetug in congenital hyperinsulinism patients, showing significant and consistent glycemic improvements via continuous glucose monitoring compared to placebo. Although the primary endpoint was not met, the study demonstrated clinically relevant reductions in hypoglycemia and increased blood glucose levels during maintenance dosing and in an ongoing open-label extension phase. The FDA acknowledged challenges with the primary endpoint and requested broader data for evaluation, with Rezolute optimistic about advancing the program toward approval. These results highlight ersodetug's potential to transform treatment for congenital hyperinsulinism.
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