Eledon Pharmaceuticals (NASDAQ:ELDN) received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its drug candidate Tegoprubart for the Prevention of Allograft Rejection in Pancreatic Islet Cell Transplantation.
Tegoprubart is an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target with broad therapeutic potential.
Tegoprubart is currently investigated in a Phase 2a clinical study for the prevention of allograft rejection in pancreatic islet cell transplantation as part of a CNI-free immunosuppressive regimen.
David-Alexandre C. Gros, MD, Chief Executive Officer, commented : "Tegoprubart has the potential to ameliorate islet cell transplant therapy outcomes by improving graft survival and function while also reducing side effects associated with CNIs. Coming on the heels of positive topline data results from our Phase 2a clinical trial in ALS, this marks another important milestone for tegoprubart as a potentially transformative treatment option."
Tegoprubart previously received orphan drug designation from the FDA for the treatment of amyotrophic lateral sclerosis (ALS).
FDA grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States. It also provides benefits of seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.
Eledon Pharmaceuticals shares are currently trading at $3.51, up 2 percent in the pre-market session, compared with the previous day closing price of $3.22.
