Rezolute gains FDA alignment on streamlined Phase 3 trial design for ersodetug in tumor HI

Rezolute, Inc.

FDA agreed to remove double-blind placebo-controlled requirement; study now open-label, single-arm.
Phase 3 upLIFT trial will enroll as few as 16 patients with tumor hyperinsulinism (HI).
Topline data from upLIFT expected in the second half of 2026.
FDA confirmed that the pivotal sunRIZE trial in congenital HI (topline Dec 2025) serves as confirmatory evidence.
FDA meeting held August 19, 2025; simplified path based on Expanded Access Program outcomes in over 10 patients.

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