RZLT - Rezolute, Inc.
Rezolute Provides Update on FDA Review of its Phase 3 sunRIZE Study Results in Congenital Hyperinsulinism
Data from the Phase 3 sunRIZE study remains under review by FDA The OLE Phase of the study is ongoing, with a high participation rate and several indicators of improved glycemic control, including a notable reduction in the use of background standard of care therapies Enrollment continues in the Phase 3 upLIFT study in tumor HI and the Company remains on track to report topline results before the end of 2026 REDWOOD CITY, Calif., Sept. 09, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (“HI”), today provided an update on the status of the ongoing U.S. Food and Drug Administration (“FDA” or “Agency”) review of data from the Company's Phase 3 sunRIZE study of ersodetug for the treatment of hypoglycemia due to congenital HI.
