Rezolute (RZLT) said the US Food and Drug Administration granted breakthrough therapy designation for its investigational treatment for ersodetug, a treatment for hypoglycemia caused by tumor hyperinsulinism.
The designation was awarded based on clinical trial data across an overall development program that showed the treatment works in a way that directly targets the underlying cause of the tumor hyperinsulinism, the company said Monday in a statement.
Rezolute plans to start a registrational study of the drug in patients with tumor hyperinsulinism in the middle of this year with topline results expected in H2 2026.
The company is also evaluating ersodetug for the treatment of hypoglycemia caused by congenital hyperinsulinism in a Phase 3 trial.
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