Rezolute Gets FDA Clearance For IND Application For RZ358 - Quick Facts

(RTTNews) - Rezolute (RZLT) said it received FDA clearance for Investigational New Drug application for RZ358 to treat hypoglycemia in patients with tumor hyperinsulinism. The company is initiating start-up activities for the study which will be primarily conducted in the U.S. and patient enrollment is planned to commence in the first half of 2025.

Ersodetug is also being studied in an ongoing global, Phase 3 clinical trial in patients with congenital HI. Topline data from the study is expected in mid-2025.

Shares of Rezolute are down 6% in pre-market trade on Monday.

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