Rezolute disclosed that its Phase III Sunrize trial of ersodetug in congenital hyperinsulinism missed primary and key secondary endpoints, triggering an immediate market rout. The company said changes in weekly hypoglycemia events and time-in-hypoglycemia were not statistically different versus placebo, and two serious hypersensitivity events led to early discontinuations. Investors reacted sharply: public shares plunged after the announcement and management said it will meet with the FDA to discuss next steps. Company executives framed the outcome as disappointing but signaled further analyses and ongoing programs that could influence any future path.
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