Clinical Trials And Regulatory ProgressThe FDA lifted the partial clinical hold on the RZ358 program, allowing the ongoing global Phase III study to include U.S. sites.
Market Potential And ExpansionRZ358 should benefit approximately 75% of the estimated 3,500 congenital hyperinsulinism patients in the U.S. and EU, which require pharmacological treatment.
Product Efficacy And SafetyPublished or presented data have demonstrated promising clinical benefit with patients refractory to multiple current standard of care achieving glycemic control after RZ358 treatment.