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YahooSeptember 9, 2026 at 10:43 AM NYLast Month

Rezolute FDA Review Continues After Phase 3 sunRIZE Study Missed Primary Endpoint

Rezolute (NASDAQ:RZLT) said the FDA is continuing its review of additional Phase 3 sunRIZE data for ersodetug in congenital hyperinsulinism after the study failed to meet its primary endpoint, leaving the potential regulatory path unresolved and without a specific timeline for agency feedback. Key Investor TakeawaysThe FDA review remains ongoing as the agency evaluates whether there is a potential regulatory path forward for ersodetug in congenital hyperinsulinism.

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