Rezolute receives breakthrough therapy designation for treatment of hypoglycemia
Press Room
Rezolute (NASDAQ:RZLT) rose 6% after it announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to ersodetug for the treatment of hypoglycemia due to congenital HI.
The Breakthrough Therapy Designation is based primarily on results from the Phase 2b study of ersodetug in participants with congenital HI, which safely demonstrated significant improvements in hypoglycemia of 75% or better, with no clinically significant hyperglycemia.