Advancing the Phase 3 upLIFT study, a global, single-arm, open-label registrational trial evaluating the safety and efficacy of ersodetug (RZ358) in patients with hypoglycemia caused by tumor hyperinsulinism.

Expected impact: Aims to establish ersodetug as a universal treatment for refractory hypoglycemia caused by islet cell and non-islet cell tumors, addressing a high unmet medical need.

Engaging with the FDA under Breakthrough Therapy Designation to submit comprehensive clinical trial reports and analysis datasets from the Phase 3 sunRIZE study and its ongoing open-label extension (OLE) for independent regulatory review.

Expected impact: To determine if the broader dataset, including continuous glucose monitoring (CGM) metrics and long-term OLE efficacy, can support a marketing application (BLA) despite the trial missing its primary endpoint due to behavioral confounding factors.

Advancing RZ402, an oral small-molecule plasma kallikrein inhibitor (PKI), as a non-invasive, daily oral alternative to standard-of-care intravitreal anti-VEGF injections for patients with diabetic macular edema.

Expected impact: Provides a less burdensome, oral systemic therapy that targets an alternative pathway to improve visual outcomes and reduce vascular leakage in DME patients.