Rezolute announced that Sunrize, the Phase 3 study of its sole therapeutic candidate ersodetug for congenital hyperinsulinism, failed to meet primary and key secondary endpoints. The company reported that reductions in hypoglycemia events and time in hypoglycemia did not achieve statistical separation from placebo across prespecified comparisons. Rezolute said it will conduct a thorough evaluation of the dataset and engage the U.S. Food and Drug Administration to determine next steps for the program. The company noted safety signals in the trial that require further analysis and regulatory discussion. The outcome leaves Rezolute without a clear near-term commercial product and necessitates strategic decisions about pipeline prioritization, governance and capital allocation as management consults with regulators and stakeholders.