Rezolute (RZLT) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, to ersodetug, RZ358, for the treatment of hypoglycemia due to congenital HI. Breakthrough Therapy Designation granted based on key positive data from the Phase 2b study and current unmet medical need in congenital hyperinsulinism. Ersodetug continues to advance in clinical development as a potential treatment for hypoglycemia caused by all forms of hyperinsulinism; topline sunRIZE data expected second half of this year.
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