regulatory
confidence high
sentiment neutral
materiality 0.65
Rezolute: FDA recommends pre-BLA meeting for ersodetug in congenital HI despite sunRIZE missing primary endpoint
Rezolute, Inc.
- FDA recommended a Type B pre-BLA meeting as a precursor to a BLA for ersodetug in congenital hyperinsulinism, after reviewing data Rezolute submitted in June 2026.
- sunRIZE Phase 3 missed its primary endpoint: finger-stick SMBG hypoglycemia event reductions were not statistically significant vs placebo; key CGM secondary endpoint at Week 24 also not met.
- FDA explicitly did not opine on approvability of ersodetug for congenital HI, noting any determination would only come during a formal BLA review.
- Topline results from the Phase 3 upLIFT study in tumor HI are expected this quarter; Rezolute will then evaluate BLA strategy for potentially both programs.
- sunRIZE open-label extension ongoing with high retention; ersodetug treatment duration ranges ~9 months to over 2 years, with continued glycemic control and reduced background standard of care.