Rezolute updates on ersodetug trials, FDA review, fiscal 2026 results
The company reported interim upLIFT progress, an ongoing FDA review of the sunRIZE congenital HI data, and $107.8 million in cash and investments as of June 30, 2026.
Rezolute, Inc. reported fourth quarter and full year fiscal 2026 results on September 24, 2026, alongside updates on its two late-stage programs for ersodetug in hyperinsulinism (HI).
In tumor HI, the company said the Phase 3 upLIFT study is a single-arm, open label trial enrolling up to 16 hospitalized participants, and enrollment is ongoing.1 Topline results are expected before the end of 2026.1 Rezolute said that as of a June 2026 interim look, six of the eight participants enrolled had met the responder criterion for the study's primary endpoint during the 8-week pivotal treatment phase, and each of those six also fully stopped needing intravenous glucose while on ersodetug.1 A seventh participant has since met the responder criterion as well.1 One enrolled participant, who had Stage 4 metastatic colon cancer and a poor ECOG 4 performance status1, withdrew consent and discontinued ersodetug before completing the pivotal phase, transitioning to hospice care and dying a week later from cancer progression1; that participant is being counted as a non-responder for the primary endpoint analysis.1
In congenital HI, Rezolute said the Phase 3 sunRIZE study, which missed its primary endpoint, remains under review with the FDA as of September 2026.1 In June 2026 the company submitted additional data to the agency, including source and analysis datasets and results from numerous pre-specified, post-hoc, and sensitivity analyses focused on continuous glucose monitoring outcomes.1 The study's open-label extension phase continues, with high participation and signs of improved glycemic control, including less use of background standard-of-care therapies.1 Rezolute said it will keep awaiting FDA feedback and retains the option to request a formal meeting under a regulatory timeline if needed.1
On finances, the company held $107.8 million in cash, cash equivalents and marketable securities as of June 30, 2026, down from $167.9 million a year earlier.1 Full-year net loss was $77.6 million, compared with $74.4 million in fiscal 2025.1
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