HI-Bio™ Receives Orphan Drug Designation for Felzartamab Targeted Therapy

HI-Bio™ has received Orphan Drug Designation from the FDA for felzartamab, a targeted therapy for antibody-mediated rejection in kidney transplant recipients. This designation is a significant milestone in addressing the critical unmet medical need for AMR, with potential breakthrough implications. The Orphan Drug Designation qualifies HI-Bio for certain development incentives, expected to accelerate the development of felzartamab and enhance the company’s ability to bring this innovative therapy to patients in need.