Rezolute Announces FDA Alignment for Ersodetug Phase 3 Trial in Tumor HI.

Rezolute, a rare disease company, has gained FDA alignment on a streamlined Phase 3 trial for its treatment, ersodetug, for hypoglycemia caused by tumor hyperinsulinism. The trial will be an open-label study in as few as 16 patients and is now enrolling in the U.S. and Europe. Topline data is expected in the second half of 2026.