Rezolute Says FDA Recommends Pre-BLA Meeting for Congenital Hyperinsulinism Treatment

MT newswire2026/10/05 12:04

08:04 AM EDT, 10/05/2026 (MT Newswires) -- Rezolute (RZLT) said Monday that the US Food and Drug Administration has recommended a meeting before its submission of a biologics license application for its drug ersodetug as a potential treatment for hypoglycemia due to congenital hyperinsulinism. The proposed meeting follows a preliminary review of data from a phase 3 study which did not meet the primary endpoint because the reductions in hypoglycemia events by finger-stick self-monitored blood glucose were not statistically significant compared to placebo, the company said. A key secondary endpoint of time in hypoglycemia was not met, although "consistent and clinically relevant improvements" in hypoglycemia were observed, the company said. The FDA did not opine on the approvability of ersodetug and noted any such determination would only be made as part of an in-depth evaluation of the supporting data during a formal BLA review, as is customary during a BLA process. Shares of the company were up 7.5% in recent premarket trading.

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