Rezolute Inc. (NASDAQ:RZLT) stock is plunging on Thursday, with a session volume of 82.25 million compared to the average volume of 1.597 million as per data from Benzinga Pro.
The company on Thursday released topline results from its Phase 3 sunRIZE study evaluating ersodetug in patients with congenital hyperinsulinism (HI).
Congenital Hyperinsulinism is a rare genetic disorder causing the pancreas to secrete too much insulin, leading to dangerously low blood sugar (hypoglycemia) in infants and children.
The study did not meet its primary endpoint, which assessed the change in the average weekly hypoglycemia events by self-monitored blood glucose.
Data
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 the 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 three 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.
Safety observations from the study were generally favorable and, in the opinion of the company, support safe use of ersodetug in pediatric and adult patients.
Two of the study participants experienced serious hypersensitivity reactions, which led to early discontinuation of the study drug.
The Phase 3 upLIFT study for tumor HI is ongoing, with topline results expected in the second half of 2026.
RZLT Price Action: Rezolute shares were down 88.76% at $1.23 at the time of publication on Thursday. The stock is trading at a new 52-week low, according to Benzinga Pro data.
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