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Market
Will the FDA approve Rezolute's RZ358 treatment by September 30, 2025?
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Resolution / Starting Odds
Yes • 50%
No • 50%
FDA official announcements or Rezolute Inc press releases
Story
FDA Lifts Partial Hold on Rezolute's Phase 3 Treatment for Congenital Hyperinsulinism
Sep 9, 2024, 12:00 PM
Rezolute Inc announced on Monday that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on its experimental treatment, RZ358, for congenital hyperinsulinism. This decision allows the inclusion of U.S. participants in the ongoing Phase 3 study. The treatment aims to address low blood sugar levels associated with the condition.
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Accelerated Approval • 25%
Full Approval • 25%
Conditional Approval • 25%
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