Rezolute says FDA review continues for Phase 3 sunRIZE data on ersodetug in congenital hyperinsulinism

• Rezolute flagged an ongoing FDA review of Phase 3 sunRIZE data for ersodetug in congenital hyperinsulinism; results were already reported.
• The pivotal trial showed fewer hypoglycemia events versus baseline, yet missed its primary endpoint versus placebo, clouding the near-term filing path.
• FDA is assessing additional analyses submitted in June 2026; no timeline has been set for feedback or next steps.
• An open-label extension remains active, with continued participation and signs of sustained clinical benefit, including reduced reliance on standard therapies.
• Enrollment continues in the Phase 3 upLIFT study in tumor hyperinsulinism; topline results are expected before end-2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Rezolute Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202609090700PRIMZONEFULLFEED9823529) on September 09, 2026, and is solely responsible for the information contained therein.