FDA Grants Orphan Drug Designation To OSE's Pegrizeprument For Post-Heart Transplant Rejection

OSE Therapeutics SA announced that the FDA has granted orphan drug designation to its investigational drug, pegrizeprument, for preventing heart allograft rejection post-transplant. Pegrizeprument, a monoclonal antibody fragment licensed to Veloxis Pharma, also received orphan designation for liver transplant rejection in January 2026. The stock is currently trading at $3.75, up 24.14%.

(RTTNews) - OSE Therapeutics SA (OSE.PA), a clinical-stage biotechnology company, announced on Monday that the FDA has granted orphan drug designation to pegrizeprument in prophylaxis of heart allograft rejection after a heart transplant.

Pegrizeprument (VEL-101), a novel, investigational, immunomodulating, pegylated, monoclonal monovalent antibody fragment, was licensed to Veloxis Pharma in 2021. It acts by blocking CD28-mediated T-cell activation, allowing indirectly for the CTLA-4 mediated immunosuppressive function. Originally developed by OSE, it has been licensed by Veloxis for manufacture and commercialization.

Pegrizeprument received an orphan drug designation in January 2026 for preventing organ rejection in liver transplant cases and is currently being explored for treating rejection in solid organ transplants. OSE.PA is currently trading at $3.75, up 24.14%.

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