- The shares of clinical-stage biotech Eledon Pharmaceuticals, Inc. ( NASDAQ: ELDN ) gained 10% in post-market trading Friday after the company announced that the FDA cleared its Investigational New Drug (IND) application for kidney disease therapy tegoprubart.
- Phase 2a trial for the candidate is currently underway globally, targeting patients with IgA Nephropathy, which can lead to End-Stage Renal Disease, dialysis, renal transplant, and death with a progressive impact on kidney function.
- With the IND clearance for tegoprubart in IgA, the company plans to open U.S. trial sites for the open-label study, which will enroll up to 21 patients worldwide in each of the two dose cohorts.
- Following regulatory clearance in 10 countries to study tegoprubart in IgA, ELDN plans to expand the trial to two more countries, including China.
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Early August, ELDN announced that the FDA greenlighted a mid-stage trial for tegoprubart as a treatment to prevent organ rejection in patients who underwent a kidney transplant.
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Eledon adds 10% as FDA clears clinical trial for kidney disease candidate