RZLT

Announcements

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Daily updates

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FDA designations

• Rezolute has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational drug, Ersodetug, for the treatment of hypoglycemia resulting from tumor-induced hyperinsulinism.May 6, 2025

News

• Rezolute completes enrollment in the Phase 3 upLIFT trial evaluating ersodetug for tumor hyperinsulinismOct 14, 2026
• Rezolute announces FDA recommendation for a pre-BLA meeting ahead of a planned BLA submission for congenital hyperinsulinismOct 5, 2026
• Rezolute provided insights from Phase 3 sunRIZE Study and expanded access findingsJan 7, 2026
• Rezolute announces Phase 3 sunRIZE study results in congenital hyperinsulinismDec 11, 2025
• Rezolute secures FDA alignment on streamlined Phase 3 upLIFT trial of Ersodetug for tumor hyperinsulinism; study simplified to 16-patient open-label design, supported by sunRIZE confirmatory data expected December 2025Sep 2, 2025