FDA lifts partial hold on Rezolute's ersodetug for congenital hyperinsulinism, enabling US enrollment in Phase 3 sunRIZE study.

The FDA has lifted partial clinical holds on Rezolute, Inc.'s treatment, ersodetug, for hypoglycemia caused by congenital hyperinsulinism. This allows U.S. enrollment in the ongoing Phase 3 sunRIZE study, expected to begin in early 2025, with results anticipated in the second half of 2025. The FDA determined that previously noted liver toxicity in lab rats is not relevant to humans. Rezolute's stock rose following the announcement.

September 09, 2024
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