FDA lifts partial clinical holds on Rezolute's RZ358 for congenital hyperinsulinism

Rezolute, Inc.

FDA removed partial clinical holds on RZ358 (ersodetug) for hypoglycemia in congenital HI; U.S. enrollment in global Phase 3 sunRIZE study now permitted.
FDA concluded liver toxicity in Sprague Dawley rats is strain-specific and not relevant to humans.
Company expects to begin U.S. participant enrollment in early 2025; topline data from sunRIZE study anticipated in H2 2025.
This follows prior FDA clearance of a separate Phase 3 study in tumor-associated HI, advancing ersodetug in two rare disease programs.

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