Rezolute disclosed that its Phase 3 Sunrize study of ersodetug for congenital hyperinsulinism missed primary and key secondary endpoints, prompting management to halt investor guidance and plan regulatory discussions. The trial failed to show a statistically significant reduction in weekly hypoglycemia events versus placebo; the company noted safety signals including serious hypersensitivity in two patients. Investors reacted swiftly, sending the stock tumbling sharply after the update. Rezolute said it will meet with the FDA to evaluate next steps and will continue to assess the program, including an ongoing Phase 3 in tumor‑related congenital hyperinsulinism. The clinical failure raises questions about the molecule’s future and the company’s commercial plans.