Rezolute Said FDA Is Still Reviewing Ersodetug Submission In Congenital Hyperinsulinism; The Company Continues To Await Feedback And Reserves The Ability To Request Formal Meeting Under Regulatory Timeline
Benzinga·09/09/2026 11:06:15
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- Data from the Phase 3 sunRIZE study remains under review by FDA
- The OLE Phase of the study is ongoing, with a high participation rate and several indicators of improved glycemic control, including a notable reduction in the use of background standard of care therapies
- Enrollment continues in the Phase 3 upLIFT study in tumor HI and the Company remains on track to report topline results before the end of 2026