US FDA lifts partial clinical hold on Rezolute’s low blood sugar treatment

Sept 9 (Reuters) – Rezolute Inc (RZLT.O) said on Monday the U.S. Food and Drug Administration has removed the partial clinical hold on its late-stage study testing its treatment for low blood sugar, sending its share up 11% at $4.83 in premarket trading.

The treatment, ersodetug, is currently being tested on participants with congenital hyperinsulinism, a genetic disorder that causes low blood sugar.

Rezolute anticipates potential U.S. enrollment for the study to begin in early 2025, and expects to announce results in the second half of 2025.

The study is enrolling up to 56 participants in more than a dozen countries, with eligibility ranging from three months to 45 years of age, the company said.