Rezolute Gains FDA Breakthrough Designation for Ersodetug

The latest announcement is out from Rezolute ( (RZLT) ).

Rezolute, Inc. announced that the FDA has granted Breakthrough Therapy Designation to its drug, ersodetug, for treating hypoglycemia caused by congenital hyperinsulinism. This designation, based on significant data from the Phase 2b RIZE study, highlights ersodetug’s potential to substantially improve patient outcomes, reinforcing Rezolute’s position as a leader in addressing hyperinsulinism. The company is focused on completing the sunRIZE study and initiating a Phase 3 trial for tumor HI, with the FDA’s Orphan Drug Designation further supporting its innovative approach.

More about Rezolute

Rezolute, Inc. is a late-stage biopharmaceutical company focused on developing transformative therapies for rare diseases, particularly those involving hypoglycemia due to hyperinsulinism (HI). Its primary product, ersodetug, is an antibody therapy designed to treat all forms of HI, showing significant benefits in clinical trials and real-world applications for both congenital and tumor HI.

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