Ersodetug's fate hinges on whether FDA accepts CGM-based sunRIZE data and whether upLIFT confirms tumor HI efficacy at full enrollment

Rezolute is a clinical-stage biopharmaceutical company developing ersodetug, a targeted therapy for congenital and tumor-related hyperinsulinism, neither indication yet approved.

Ersodetug, an anti-insulin receptor antibody, targets two ultra-rare hyperinsulinism indications — congenital HI and tumor HI — in severely underserved patient populations. The thesis resolves if FDA accepts the CGM-based sunRIZE dataset as sufficient for a congenital HI marketing application, or if upLIFT delivers confirmatory tumor HI efficacy. The primary risk is regulatory: FDA may require an additional controlled trial despite BTD, and no approved competitor currently blocks the path but diazoxide and octreotide remain entrenched standards of care.