Rezolute’s RZ358 Advances with FDA Clearance for Study

Rezolute ( (RZLT) ) has issued an update.

Rezolute, Inc. has made a significant leap forward as the FDA removes all partial clinical holds on their novel therapy, RZ358, designed to treat hypoglycemia caused by congenital hyperinsulinism. This clearance paves the way for the inclusion of U.S. participants in the ongoing global Phase 3 sunRIZE study. With patient enrollment anticipated to start in early 2025, the company is poised to deliver top-line data in the latter half of the year, marking a potential milestone in the treatment of this rare disease.

For a thorough assessment of RZLT stock, go to TipRanks’ Stock Analysis page.