Rezolute Application for Hypoglycemia Treatment Gets FDA Clearance
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Dow Jones
By Denny Jacob
Rezolute received a U.S. Food and Drug Administration clearance for its investigational new drug application for RZ358, a treatment for hypoglycemia in patients with tumor hyperinsulinism.
The late-stage rare disease company said on Monday that it's initiating start-up activities for the study which will primarily be conducted in the U.S. with patient enrollment planned to start in the first half of 2025.
RZ358 is also being studied in a continuing phase 3 clinical trial in patients with congenital tumor hyperinsulinism. Topline data from that study is expected in mid-2025, it said.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
August 05, 2024 08:23 ET (12:23 GMT)
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