10:34 AM EST, 01/07/2025 (MT Newswires) -- Rezolute ( RZLT ) said Tuesday it has received the US Food and Drug Administration's

Breakthrough Therapy designation for its ersodetug monoclonal antibody to treat hypoglycemia due to congenital hyperinsulinism.

The regulator's decision was based on the company's phase 2b trial of ersodetug in patients with congenital hyperinsulinism, which "safely" showed "significant improvements" in hypoglycemia by at least 75%, with no clinically significant hyperglycemia, Rezolute ( RZLT ) added.

The company said it intends to start its phase 3 trial for tumor hyperinsulinism this year.

Shares of the company rose 3.6% in recent Tuesday trading.

Price: 5.40, Change: +0.19, Percent Change: +3.55