Rezolute Says FDA Recommends Pre-BLA Meeting After Congenital Hyperinsulinism Trial Miss

The U.S. Food and Drug Administration (FDA) has recommended a pre-Biologics License Application (BLA) meeting for Rezolute, Inc. following a Phase 3 trial that missed its primary and key secondary endpoints for congenital hyperinsulinism. This advice comes after an FDA review of the trial data, and Rezolute will assess its filing strategy after upcoming tumor hyperinsulinism data.