10:59 AM EDT, 08/05/2024 (MT Newswires) -- Rezolute ( RZLT ) said Monday it has obtained US Food and Drug Administration clearance for an investigational new drug application for a phase 3 trial of RZ358 intended to treat hypoglycemia in people with tumor hyperinsulinism.

The company said it is launching start-up activities for the phase 3 trial, which will be mainly conducted in the US, with patient enrollment expected to begin in H1 2025.

RZ358 is also being assessed in an ongoing phase 3 study in people with congenital hyperinsulinism, Rezolute ( RZLT ) said, adding topline results from that study are expected in the middle of next year.

Shares of Rezolute ( RZLT ) were down more than 6% in recent trading activity.

Price: 4.03, Change: -0.27, Percent Change: -6.33