Rezolute Announces Completion of Enrollment in Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism

Rezolute Inc. (RZLT) completed enrollment in its Phase 3 upLIFT study of ersodetug for tumor hyperinsulinism, with topline results expected mid-December 2026. The study aims for a ≥50% reduction in glucose infusion rate. Earlier data showed 7 of 8 participants met the responder criterion. The company plans to continue expanded access and may advance indications in 2027 if results are favorable.

Rezolute Inc. (RZLT) completed enrollment in its Phase 3 study of ersodetug for tumor hyperinsulinism, with 16 participants. Topline results are expected in mid-December 2026. The study's primary endpoint measures a 50% reduction in glucose infusion rate. Seven of the first eight participants met the responder criterion, and the treatment has been well-tolerated. Rezolute plans to continue its expanded access program.

Rezolute, Inc. (RZLT) has completed patient enrollment in its Phase 3 upLIFT study of ersodetug for tumor hyperinsulinism. Topline results are expected mid-December 2026. Earlier, 7 of the first 8 participants met the primary responder criterion, according to the company.

H.C. Wainwright reiterated a Buy rating and $10 price target for Rezolute Inc. (RZLT) after FDA feedback on its ersodetug candidate. The stock trades at $4.33, with analysts citing regulatory developments and clinical trial progress. Rezolute plans to discuss both its congenital hyperinsulinism and tumor hyperinsulinism programs with the FDA, with upLIFT trial results expected by year-end 2026. The company has a strong balance sheet, according to InvestingPro Tips.

Citizens raised its price target for Rezolute Inc. (RZLT) to $15.00 from $11.00, citing positive FDA feedback on its Phase 3 data for congenital hyperinsulinism. The stock, currently at $4.33, has a consensus 'Buy' rating with targets ranging from $6 to $14. Recent analyst updates and clinical trial progress also support the increased target.

Rezolute announced the FDA recommended a pre-BLA meeting after reviewing Phase 3 sunRIZE data for congenital hyperinsulinism. The data showed glycemic improvements but missed primary and key secondary endpoints. Rezolute submitted additional datasets for review and expects upLIFT trial results this quarter. RZLT filed an 8-K on Oct. 5, 2026.