FDA Lifts Partial Clinical Holds On Rezolute's Ersodetug To Treat Congenital HI; Stock Up

(RTTNews) - Rezolute, Inc. (RZLT), a late-stage rare disease company, Monday said the Food and Drug Administration or FDA removed the partial clinical holds on ersodetug, a potential treatment for hypoglycemia caused by congenital hyperinsulinism (HI). This allows the company to enroll U.S. participants in the ongoing global Phase 3 study of ersodetug in HI, dubbed sunRIZE.

In pre-market activity, the stock was up more than 12 percent to $4.90.

The FDA concluded that the liver toxicity observed in Sprague Dawley rats is likely strain-specific and not relevant to humans.

Rezolute expects to start U.S enrollment in early 2025, with topline data anticipated in the second half of 2025.

The FDA has recently given clearance to a separate Phase 3 study of ersodetug in tumor-associated HI.

"we are in the unique and fortunate position to be advancing ersodetug in two Phase 3 rare disease programs in the U.S. and globally," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute.

Rezolute stock had closed at $4.35, down 0.45 percent on Friday. It has traded in the range of $0.72 - $6.10 in the last 1 year.