Rezolute announces alignment with FDA on design for Phase 3 trial of ersodetug

Rezolute (RZLT) announced that the Company has gained alignment with FDA on a significantly streamlined clinical development path for its ongoing Phase 3 study of ersodetug for the treatment of hypoglycemia caused by tumor HI. At a meeting held with FDA on August 19, 2025, the agency agreed to modifications to the design of the study including removing the need to conduct a double-blind randomized placebo-controlled trial. The truncated study will include as few as 16 participants and will be limited to the single-arm open-label portion of the upLIFT study, which has been the focus of the Company’s patient recruitment efforts. FDA also confirmed that Rezolute’s pivotal sunRIZE trial in congenital HI, which is on track to report topline results in December 2025, would serve as confirmatory clinical evidence, and is demonstrative of FDA’s recognition of the broad applicability of ersodetug in multiple forms of HI.