08:42 AM EDT, 09/02/2025 (MT Newswires) -- Rezolute ( RZLT ) said Tuesday it has reached alignment with the US Food and Drug Administration on a streamlined design for its ongoing phase 3 study of ersodetug to treat hypoglycemia caused by tumor hyperinsulinism.

The FDA endorsed modifications that remove the need for a randomized placebo-controlled trial, limiting the study to an open-label arm with 16 participants, the company said.

Rezolute ( RZLT ) also said the FDA confirmed that data from the sunRize pivotal trial in congenital hyperinsulinism would serve as confirmatory clinical evidence and show the applicability of ersodetug in multiple forms of hyperinsulinism. The company added that it is on track to release topline results in December.

Shares of Rezolute ( RZLT ) were up 1.8% in recent Tuesday premarket activity.