Business
Rezolute Reports Third Quarter Fiscal 2025 Financial Results and Provides Business Update
sunRIZE enrollment on track including U.S. sites and expected to be completed in May 2025; topline data anticipated in December 2025 U.S. Food and Drug
About this update from Rezolute, Inc.
[{"type":"text","content":"sunRIZE enrollment on track including U.S. sites and expected to be completed in May 2025; topline data anticipated in December 2025 U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor hyperinsulinism REDWOOD CITY, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today reported financial results and provided a business update for the three months ended March 31, 2025. “The Phase 3 sunRIZE study in congenital HI is on track to complete enrollment this month and we are poised to start our registrational upLIFT study for tumor HI mid-year,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. “Each of our programs received Breakthrough Therapy Designation from FDA this year. We look forward to continued discussions with the agency with a focus on treating hypoglycemia caused by all forms of hyperinsulinism with the goal of advancing our novel therapy towards approval and commercialization.” Recent Pipeline Progress and Anticipated Milestones Congenital HI sunRIZE, a Phase 3, multicenter, double-blind, randomized, controlled safety and efficacy registrational study, is ongoing and enrollment is expected to conclude in May 2025. U.S. sites are activated and enrolling patients.Topline results expected in December 2025. Upon completion of an interim analysis in April 2025, an independent Data Monitoring Committee recommended continuation of the sunRIZE study as planned without an increase to the study sample size. The analysis was intended to evaluate the study for futility or otherwise to inform a potential sample size increase, for purposes of optimizing the study power and statistical confidence in the final analysis outcomes.The Company remains blinded to the results. Tumor HI In May 2025, FDA granted Breakthrough Therapy Designation (BTD) to ersodetug for the treatment of hypoglycemia due to tumor HI. BTD was granted based on clinical trial data across the overall HI program and a recognition of the mechanistic applicability to tumor HI, further validated by real-world experience in tumor HI patients who have been successfully treated with ersodetug throughout the U.S. in the Company's Expan...