Rezolute, Inc. (RZLT), a company in the late stages of developing treatments for rare diseases, announced on Monday that the Food and Drug Administration (FDA) has lifted partial clinical holds on ersodetug, a potential therapy for hypoglycemia induced by congenital hyperinsulinism (HI). This approval permits the company to recruit U.S. participants for the ongoing global Phase 3 trial of ersodetug, known as sunRIZE.
Following the announcement, pre-market trading saw the stock rise by over 12 percent, reaching $4.90.
The FDA's decision was based on findings that liver toxicity observed in Sprague Dawley rats is likely specific to the strain and irrelevant to human cases.
Rezolute plans to commence U.S. enrollment in early 2025, with the release of topline data expected in the latter half of the same year.
Additionally, the FDA recently greenlit a separate Phase 3 trial of ersodetug for tumor-associated HI.
"We are in a unique and fortunate position to advance ersodetug through two Phase 3 programs for rare diseases, both in the U.S. and globally," stated Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute.
On Friday, Rezolute's stock had closed at $4.35, marking a 0.45 percent decline. Over the past year, the stock has fluctuated between $0.72 and $6.10.
