RZLT Stock Plummets 79% Month to Date: Here's What You Need to Know

Core Insights - Shares of Rezolute (RZLT) have dropped 79.2% in December following disappointing results from a late-stage study of its only pipeline candidate, ersodetug, for congenital hyperinsulinism (HI) [2][6] Study Overview - The phase III sunRIZE study evaluated ersodetug in HI patients aged 3 months to 45 years who continued to experience hypoglycemia despite standard care, enrolling 63 patients and testing two dose levels (5 and 10 mg/kg) against a placebo [3][4] - The study's primary endpoint, measuring the change in average weekly hypoglycemia events, was not achieved, with the highest dose showing a 45% reduction in events, which was not statistically significant compared to a 40% improvement in the placebo group [4][5] Secondary Endpoint Results - The study also missed its key secondary endpoint, which assessed the change in average daily time spent in hypoglycemia, showing a 25% reduction in the 10 mg/kg dose compared to a 5% increase in the placebo group, with no statistical significance [5][6] Stock Performance - Over the past six months, Rezolute's shares have declined by 50.4%, contrasting with the industry's growth of 22.1% [5] Safety Profile - Safety findings for ersodetug were generally favorable, with a low incidence of serious allergic events compared to other biologic therapies, although two patients experienced serious hypersensitivity reactions leading to early discontinuation [9] Future Plans - Following the disappointing phase III data, Rezolute is conducting a comprehensive review to understand the results and is preparing to meet with the FDA to discuss the next steps for the program under Breakthrough Therapy status [10] - Rezolute is also advancing ersodetug as a potential treatment for tumor-induced HI, with a streamlined clinical development path agreed upon with the FDA, initiating the upLIFT study with enrollment currently underway [11][12]