FDA Review Puts Rezolute's Genetic Disorder Drug Path In Question

In a recent update, Rezolute shared insights from its March 17 meeting with the FDA regarding its Phase 3 sunRIZE trial for ersodetug, aimed at treating congenital hyperinsulinism.FDA Meeting Highlights Mixed Efficacy Signals In SunRIZE TrialThe company reported that while the primary endpoint was not statistically significant, there were clinically meaningful improvements in hypoglycemia events as measured by continuous glucose monitoring.The FDA acknowledged the challenges posed by behavioral factors in c ...