Rezolute reports FDA recommends BLA filing for congenital HI, tumor HI data due mid-December

Rezolute, Inc. reported financial results and a business update for the first quarter of fiscal 2027, ended September 30, 2026, in a release dated November 5, 2026.

On the tumor hyperinsulinism (HI) program, the company said upLIFT, a Phase 3, single-arm, open label study in up to 16 hospitalized participants for the treatment of tumor HI, is ongoing, with enrollment complete and topline results expected by mid-December 2026.¹ Earlier in the year, the company had disclosed that seven of the eight participants enrolled in the first half of the study met the responder criterion for the study's primary endpoint.¹ Those responders also achieved complete discontinuation of intravenous glucose with ersodetug, which has been well-tolerated with no drug-related safety findings reported so far.¹ The eighth participant left the study early to pursue hospice care and died a week later from cancer progression; the company classifies this case as a non-responder for the primary endpoint.¹

For congenital HI, Rezolute said the FDA reviewed additional study data requested from the company in October 2026 and, after a pre-BLA meeting, recommended that Rezolute file for review under a Biologics License Application.¹ The company noted that the prior Phase 3 sunRIZE study of ersodetug showed glycemic improvements but missed its primary endpoint, as reductions in hypoglycemia events measured by finger-stick self-monitored blood glucose were not statistically significant versus placebo, though CGM-based hypoglycemia measures showed consistent improvement in both arms.¹ The open-label extension of sunRIZE is continuing, and the company described high participation along with signs of improved glycemic control, including less use of background standard-of-care therapies.¹

During an October 29, 2026 Guggenheim healthcare event, Rezolute discussed commercial plans for ersodetug, citing a potential $5 billion combined market opportunity and plans to submit a BLA for one or both indications in 2027.¹

Financially, cash, cash equivalents and investments in marketable securities totaled $90.0 million as of September 30, 2026, down from $107.8 million at June 30, 2026.¹ Net loss for the quarter was $18.5 million, compared with $18.2 million a year earlier.¹