Rezolute, Inc. (RZLT), a rare disease company, announced Thursday topline results from its Phase 3 sunRIZE study evaluating ersodetug in patients with congenital hyperinsulinism (HI). The study did not meet its primary endpoint, which assessed change in the average weekly hypoglycemia events by self-monitored blood glucose.
There was an approximate 45% reduction in hypoglycemia events observed at the top ersodetug dose (10 mg/kg), which was not statistically significant compared to the placebo group, which experienced a 40% improvement.
Furthermore, the study did not meet its key secondary endpoint, which assessed change in average daily percent time in hypoglycemia by continuous glucose monitoring (CGM). At the 10 mg/kg dose of ersodetug, an approximate 25% reduction in time in hypoglycemia was observed, which was not statistically significant compared to the placebo, which increased by approximately 5%.
At the study dose regimens of 5 and 10 mg/kg administered every other week for 3 doses, followed by every 4 weeks over the remainder of the 24-week treatment duration, ersodetug target drug concentrations were achieved, across all age groups studied.
The Phase 3 upLIFT study for tumor HI is ongoing with topline results expected in the second half of 2026.
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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.