FDA lifts partial clinical holds on Rezolute’s RZ358

Rezolute announced that the U.S. Food and Drug Administration has removed the partial clinical holds on RZ358, a potential treatment for hypoglycemia caused by congenital HI. Ersodetug is currently being studied in sunRIZE, a global Phase 3, multi-center, double-blind, randomized, placebo-controlled, safety and efficacy registrational study in participants with congenital HI. The Company will now commence study start-up activities in the U.S. with the goal of including U.S. participants in the global sunRIZE study. The Company anticipates potential U.S. enrollment to begin in early 2025, which will enable announcement of topline data from the study in the second half of 2025.