Rezolute Announces Positive Results from the Phase 3 upLIFT Study in Tumor Hyperinsulinism
Globe Newswire•13/11/2026•06:18 ET
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Key Highlights
- ➤13 of 16 participants met the responder criterion, including 12 stopping IV glucose
- ➤Phase 3 upLIFT primary endpoint achieved based on preliminary November 5 data evaluation
- ➤Completed-study results and primary endpoint statistical analysis expected by mid-December 2026
- ➤Rezolute plans FDA discussions in Q1 2027 toward potential 2027 approval process
- ➤No drug-related safety findings attributed to ersodetug to date
Expert Statements
Nevan Charles Elam, Founder and Chief Executive Officer of Rezolute
“We are thrilled with this outcome and what it means for individuals living with tumor hyperinsulinism”
Nevan Charles Elam, Founder and Chief Executive Officer of Rezolute
“Notably, these results substantially mirror the powerful outcomes that we have observed over the last few years in our expanded access program.”
Nevan Charles Elam, Founder and Chief Executive Officer of Rezolute
“We believe that we are well positioned to advance both congenital HI and tumor HI into the approval process next year and we look forward to discussions with FDA in the first quarter of 2027.”
Primary efficacy endpoint achieved based on preliminary results from a November 5(th) data evaluation
Topline results for the completed study, along with additional study details including statistical analysis of the primary endpoint, are expected by mid-December 2026
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