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Eledon Pharmaceuticals Says FDA Grants Fast Track Designation To Tegoprubart For Prevention Of Rejection In Kidney Transplantation; Expects To Initiate Phase 3 LEGACY Study In Q4 2026

Benzinga Newsdesk 1 month ago

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Tegoprubart-treated patients maintained statistically significantly higher kidney function as measured by mean eGFR through 24 months, with an approximately 13 mL/min/1.73 m² advantage versus tacrolimus (71 vs. 58

Tegoprubart-treated patients maintained statistically significantly higher kidney function as measured by mean eGFR through 24 months, with an approximately 13 mL/min/1.73 m² advantage versus tacrolimus (71 vs. 58 mL/min/1.73 m²) at month 24

No rejections occurred in the tegoprubart arm beyond six months post-transplant, compared with seven in the tacrolimus arm

Tegoprubart granted U.S. FDA Fast Track designation for the prevention of rejection in kidney transplantation

Phase 3 LEGACY study expected to initiate in the fourth quarter of 2026

IRVINE, Calif., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. ("Eledon") (NASDAQ:ELDN) today announced updated long-term data from its Phase 2 BESTOW clinical program evaluating tegoprubart in patients undergoing kidney transplantation, presented at the International Congress of The Transplantation Society, taking place September 20-23, 2026, in Sydney, Australia. The Company also announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to tegoprubart for the prevention of rejection in kidney transplantation.

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