Rezolute, Inc. — Form 8-K

The FDA recommended Rezolute hold a Type B pre-BLA meeting for ersodetug in congenital hyperinsulinism, despite the Phase 3 sunRIZE study failing to meet its primary endpoint (statistically significant reduction in hypoglycemia by finger-stick monitoring). The Agency acknowledged the study's secondary CGM-based endpoints showed clinically relevant improvements and requested detailed data review; however, the FDA explicitly withheld any opinion on approvability and noted that a new randomized trial may be required. Rezolute expects topline results from the upLIFT study (tumor HI indication) this quarter and will decide its BLA submission strategy after those results.