FDA Grants Orphan Drug Designation to OSE Immunotherapeutics' Pegrizeprument for Liver Transplantation

Reuters
2026.01.21 17:00
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OSE Immunotherapeutics SA has received Orphan Drug Designation from the FDA for pegrizeprument (VEL-101), aimed at preventing organ rejection in liver transplant patients. This investigational drug, a monoclonal antibody fragment, is licensed to Veloxis Pharmaceuticals for global development and commercialization. The designation is for treatments targeting rare diseases affecting fewer than 200,000 individuals in the U.S.