Rezolute, Inc. (RZLT),a late-stage biopharmaceutical company, Tuesday said that the U.S. Food and Drug Administration or FDA has granted orphan drug designation to ersodetug for the treatment of hypoglycemia due to tumor hyperinsulinism (HI).
Orphan Drug Designation offers benefits including seven years of market exclusivity after approval, tax credits for clinical trials, and potential qualification for expedited pathways to approval.
A Phase 3 Registrational trial of ersodetug in patients with hypoglycemia due to tumor HI is expected to start in 2025.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.