OSE Immunotherapeutics SA  welcomes the announcement by its partner Veloxis Pharmaceuticals, Inc. that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to pegrizeprument (VEL‑101) for the prophylaxis of heart allograft rejection in patients receiving a heart transplant. This follows the recent ODD granted in January 2026 for prevention of organ rejection in patients receiving a liver transplant.

Pegrizeprument (also known as VEL-101) is a novel investigational immunomodulatory monoclonal monovalent antibody fragment originally discovered and developed by OSE Immunotherapeutics and licensed to Veloxis in 2021 for all transplant-related indications. Veloxis is responsible for the global development, manufacturing, and future commercialization of the product.

ORPHAN DRUG DESIGNATION
The FDA Orphan Drug Designation program grants orphan status to investigational drugs and biologics which aim to prevent, diagnose or treat rare diseases and medical conditions that affect fewer than 200,000 people in the United States. This law encourages development of treatments for patients with rare diseases whose conditions are traditionally undertreated.