Rezolute’s Phase 3 Sunrize study of ersodetug failed to meet its primary and key secondary endpoints in congenital hyperinsulinism, prompting the company to signal program uncertainty and to plan FDA discussions. The trial’s lack of statistical separation versus placebo across prespecified measures led to a swift market reaction and a near‑total collapse in market capitalization. Investors sold off aggressively as the company disclosed futility, with an immediate share‑price plunge that reflected limited near‑term upside given the drug was the company’s sole late‑stage asset. Management said it would review the dataset and meet regulators to discuss next steps, while stressing ongoing evaluation of other indications or subgroups. The episode is a cautionary example of binary clinical risk in small biotechs and will likely trigger re‑examination of program design, endpoint selection and go/no‑go criteria across firms with single‑asset strategies.