Rezolute (RZLT) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, to its investigational therapy, ersodetug, for the treatment of hypoglycemia caused by tumor HI. Rezolute plans to initiate a registrational study of ersodetug in patients with tumor HI in the middle of 2025, with topline results anticipated in the second half of 2026. In parallel and utilizing its BTD, the Company plans to engage further with FDA to discuss the registrational trial, including the necessary data package to support a BLA filing and potential approval for the tumor HI indication, as an expansion of the congenital HI indication.
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