By Elias Schisgall
Rezolute shares plummeted after the pharmaceutical company said its Phase 3 trial for a congenital hyperinsulinism treatment failed to meet its primary endpoint.
The stock fell 89% to $1.21 in Thursday morning trading. Shares are down 75% year to date.
The Redwood City, Calif.-based company said Thursday that its sunRIZE study for ersodetug did not meet its primary endpoint of reducing hypoglycemia events for patients with congenital hyperinsulinism, a genetic condition that causes the overproduction of insulin.
The 45% improvement in patients who received ersodetug was not statistically significant compared with the placebo group, which saw a 40% improvement, the company said.
The study also did not meet its key secondary endpoint of showing a statistically significant improvement in average daily percent time in hypoglycemia, Rezolute said.
Rezolute's chief medical officer, Brian Roberts, said the company was disappointed in the results.
"At the same time, there are aspects of the results that merit additional investigation, and we are conducting a thorough evaluation to gain a better understanding of the study outcomes, which will inform our path forward," Roberts said, adding that the company intends to meet with the Food and Drug Administration to discuss future steps.
The trial reported generally favorable safety observations, the company said.
It said its Phase 3 trial for a treatment for tumor hyperinsulinism is ongoing, with results expected in the second half of 2026.
Write to Elias Schisgall at elias.schisgall@wsj.com
(END) Dow Jones Newswires
December 11, 2025 10:36 ET (15:36 GMT)
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