FDA Encourages Rezolute to Submit sunRIZE Data for Marketing Approval
Rezolute presented sunRIZE Phase 3 data to the FDA showing consistent CGM-based hypoglycemia improvements despite missing statistical significance on its primary endpoint. FDA encouraged submission of comprehensive sunRIZE and open-label extension datasets for independent evaluation to determine sufficiency for a marketing application, with an update expected in H2 2026.
1. FDA Meeting Outcomes
On March 17, Rezolute held an in-person Type B meeting with the FDA to discuss sunRIZE, its Phase 3 study of ersodetug for congenital hyperinsulinism. FDA acknowledged challenges from behavioral confounders in self-monitored glucose data but expressed engagement with the efficacy signals and biomarker evidence presented.
2. sunRIZE Trial Findings
The pivotal sunRIZE study showed reductions in hypoglycemia events from baseline but failed to achieve statistical significance versus placebo, which Rezolute attributes to pronounced study effects. Continuous glucose monitoring endpoints demonstrated consistent and clinically meaningful improvements, and target therapeutic concentrations produced sensitive biomarker responses indicating pharmacologic activity.
3. Next Steps for sunRIZE Program
FDA encouraged Rezolute to submit full study reports and analysis datasets, including open-label extension results, for independent review to assess whether data support a marketing application. Rezolute expects to report progress on regulatory discussions and potential application filings in the second half of 2026.