Rezolute's Phase 3 upLIFT study of ersodetug in tumor hyperinsulinism hits primary endpoint

Rezolute, Inc.

• 13 of 16 participants met the ≥50% GIR reduction responder criterion, including 12 with complete IV glucose discontinuation; threshold was ≥9 responders (≥56%).
• Primary endpoint achievement based on preliminary results from a November 5, 2026 data evaluation; topline and statistical analysis expected by mid-December 2026.
• One participant discontinued early to enter home hospice and died a week later from cancer progression; classified as a non-responder.
• Enrollment: 16 participants — 4 with non-islet cell tumors and 12 with insulin-secreting malignant insulinomas; ersodetug dosed 9 mg/kg weekly for 8 weeks.
• Ersodetug well-tolerated with no drug-related safety findings; CEO Nevan Elam targets FDA discussions in Q1 2027 for congenital and tumor HI.