Rezolute says FDA review continues for Phase 3 sunRIZE data on ersodetug in congenital hyperinsulinism
RZLT•FDA review of Phase 3 sunRIZE data continues
Rezolute said the FDA review of Phase 3 sunRIZE data for ersodetug in congenital hyperinsulinism remains ongoing. The results of the pivotal trial were already reported.
The trial showed fewer hypoglycemia events versus baseline, but missed its primary endpoint versus placebo, clouding the near-term filing path.
The FDA is assessing additional analyses submitted in June 2026, and no timeline has been set for feedback or next steps.
Extension study and additional development program continue
An open-label extension remains active, with continued participation and signs of sustained clinical benefit, including reduced reliance on standard therapies.
Enrollment continues in the Phase 3 upLIFT study in tumor hyperinsulinism, and topline results are expected before end-2026.
