2026-03-24 11:31:29
Rezolute, Inc. Provides Update on Congenital Hyperinsulinism Program Following FDA Meeting
Expected Stock impact: Slightly Positive
On March 24, 2026, Rezolute, Inc. (Nasdaq: RZLT) announced the outcomes from its recent Type B meeting with the U.S. Food and Drug Administration (FDA) regarding its sunRIZE program, a Phase 3 clinical trial for the treatment of congenital hyperinsulinism (HI). The FDA encouraged the company to submit comprehensive data from the sunRIZE study and the ongoing open-label extension to inform next steps for the program. While the sunRIZE study demonstrated reductions in hypoglycemia events, it did not meet its primary endpoint due to a lack of statistical significance compared to placebo. However, the FDA acknowledged the challenges posed by behavioral factors in clinical trials for this heterogeneous patient population. The company presented evidence of pharmacologic activity and consistent improvements in glycemic endpoints compared to placebo. The FDA's feedback was described as preliminary but positive, indicating a willingness to review further data to assess the potential for a marketing application for sunRIZE. Rezolute expects to provide an update on the program in the second half of 2026.
