other material
confidence high
sentiment positive
materiality 0.75
Rezolute's Phase 3 sunRIZE study of ersodetug gets positive DMC recommendation; enrollment May, data Dec 2025
Rezolute, Inc.
- Independent DMC recommends continuation of sunRIZE study as planned; no need to increase sample size.
- Enrollment expected to complete in May 2025; topline data anticipated in December 2025.
- U.S. sites now activated and enrolling; global study across more than a dozen countries.
- Interim analysis evaluated primary endpoint of hypoglycemia events after ~50% of patients completed assessments.
- Rezolute remains blinded to interim data; DMC recommendation based on pre-specified futility and sample size assessment.