Rezolute's Congenital Hyperinsulinism Program Update: FDA Meeting Outcomes

Rezolute announced outcomes from a Type B meeting with the FDA regarding its congenital hyperinsulinism program. The Phase 3 study, sunRIZE, did not meet its primary endpoint due to a pronounced study effect, but showed consistent and clinically significant improvements in time in hypoglycemia compared to placebo. The FDA acknowledged the challenges of clinical trials in this patient population and emphasized the need for adequate and well-controlled studies to evaluate substantial evidence of efficacy. The next step for the program is to discuss summary outcomes from the pivotal portion of the study at an upcoming scientific conference.