Rezolute Presents Plans for Ersodetug BLA Filings in 2027

• Rezolute outlined plans to file biologics license applications for ersodetug in congenital and tumor hyperinsulinism in 2027.
• The FDA encouraged a pre-filing meeting for congenital hyperinsulinism following its review of additional study data.
• The Phase 3 sunRIZE trial missed its primary endpoint; the presentation attributed this to a confounding placebo effect from functional unblinding.
• Time in hypoglycemia fell 32% versus placebo at 10 mg/kg at week 24, but was not statistically significant (p=0.30).
• Cash of approximately $180 million provides funding through 2028.

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 on November 13, 2026, and is solely responsible for the information contained therein.