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Biotech Daily Dose

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

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News

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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