Rezolute’s Phase III Sunrize trial of ersodetug for congenital hyperinsulinism failed to meet primary and key secondary endpoints, the company announced, triggering immediate market fallout. The 63‑patient study showed non‑significant differences versus placebo on hypoglycemia event reduction, and two serious hypersensitivity reactions prompted safety review. The company said it will meet the FDA to evaluate next steps. Investors moved quickly: the company’s shares plunged dramatically on the news. Rezolute said it will analyze the dataset for post‑hoc signals and consider regulatory dialogue; industry watchers view the outcome as a cautionary example of small‑population trial risk and the importance of robust endpoint selection.