Eledon Pharmaceuticals Reports Second Quarter 2022 Operating and Financial Results

About this update from Eledon Pharmaceuticals, Inc.

Received FDA clearance of IND application for Phase 2 trial evaluating tegoprubart for the prevention of rejection in kidney transplant recipients First patient dosed in Phase 1b trial evaluating tegoprubart for the prevention of rejection in kidney transplant recipients in Canada, the United Kingdom and Australia Reported positive topline results from Phase 2a trial of tegoprubart demonstrating safety, target engagement, and biomarker response in patients living with amyotrophic lateral sclerosis (ALS) Tegoprubart received Orphan Drug Designation from the U.S. FDA for the prevention of allograft rejection in pancreatic islet cell transplantation Conference call today at 4:30 PM ET IRVINE, Calif., Aug. 11, 2022 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported its second quarter 2022 operating and financial results and reviewed recent business highlights. “This quarter was marked by significant clinical and regulatory progress across all four tegoprubart development programs, reinforcing our confidence in tegoprubart’s broad therapeutic potential and setting the stage for the next 12 months,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We enrolled the first patient in our ex-US open-label kidney transplantation study and multiple patients in our IgAN study. In addition, the FDA gave us clearance to proceed with a kidney transplant study to evaluate whether tegoprubart is superior to the standard of care with tacrolimus. Finally, our recent positive topline Phase 2a data in ALS demonstrated dose dependent target engagement and reductions in critical pro-inflammatory biomarkers associated with ALS as well as biomarkers associated with IgAN and kidney allograft transplant rejection. We now anticipate sharing initial data from the Phase 1b kidney transplant study, the IgAN study, and the islet cell study in the first quarter of 2023, as well as providing additional guidance on timing for the new Phase 2 kidney transplant study and next steps in ALS.” Second Quarter 2022 and Recent Corporate Developments Received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) for a larger, controlled, Phase 2 trial of tegoprubart for the prevention of organ rejection in persons receiving a kidney transplant. This study will run in parallel to the ongoing P...

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