Rezolute Gets FDA Recommendation For Pre-BLA Meeting Ahead Of Ersodetug BLA Submission For Congenital Hyperinsulinism Treatment.

The Agency reiterated its commitment to addressing the unmet need for treatment of congenital and tumor-related hyperinsulinism and to serving these patient communities On track to report topline results for the Phase 3 upLIFT study in tumor HI this quarterREDWOOD CITY, Calif., Oct. 05, 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 announced that following a preliminary review of detailed data from the Phase 3 sunRIZE study of ersodetug for the treatment of hypoglycemia due to congenital HI, the U.S. Food and Drug Administration ("FDA" or "Agency") recommended a pre-BLA meeting with the Company as a precursor to submitting a BLA.As previously reported, sunRIZE, a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital HI, demonstrated glycemic improvements, but did not meet the primary endpoint because the reductions in hypoglycemia events by finger-stick self-monitored blood glucose (SMBG) were not statistically significant compared to placebo. Although the key secondary endpoint of time in hypoglycemia by continuous glucose monitoring (CGM) was not met in the Week 24 End-of-Treatment evaluable window, consistent and clinically relevant improvements in hypoglycemia were observed for this and multiple other CGM-based hypoglycemia endpoints in both treatment arms.At a March 2026 Type B meeting with FDA, the Agency acknowledged the challenges posed by behavioral factors in clinical trials in this patient population, including limitations associated with SMBG based measures of hypoglycemia. At the meeting, the Agency requested that the Company provide the continuous CGM data for its independent review. In June 2026, the Company submitted source and analysis datasets, and summary results from a substantial number of pre-specified, post-hoc, and sensitivity analyses.The Agency has reviewed the data and, despite the trial’s failure to meet the prespecified primary and key secondary endpoints, as a next step, encouraged the Company to request a Type B pre-BLA meeting as a precursor to submitting a BLA for congenital HI. The Agency explicitly did not opine on the approvability of ersodetug for congenital HI and noted that any such determination would only be made as a part of an in-depth evaluation of the supporting data during a formal BLA review, as is customary during a BLA process.In light of expected topline results this quarter from the Company’s upLIFT study in tumor HI and the potential for an additional pre-BLA meeting for that indication should the study results support a submission, the Company will evaluate its overall BLA submission strategy for potentially both programs following the announcement of upLIFT study results.