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ELDNBullishIndustry Newsnews

High materiality9/10

Eledon advances tegoprubart with FDA Fast Track and LEGACY Phase 3 plans

Sep 22, 2026, 7:53 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Positive long-term data, a regulatory milestone (Fast Track), and a large Phase 3 trial start signal potential improvement in valuation and risk/reward for ELDN.

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What happened, with direct paths to the underlying reporting

Eledon reported longer-term BESTOW data showing tegoprubart improves kidney graft function versus tacrolimus, with a 24-month mean eGFR of 71 versus 58 mL/min/1.73 m². There were no biopsy-proven acute rejections beyond six months in tegoprubart, while seven occurred in tacrolimus. FDA Fast Track designation supports a Q4 2026 initiation of the LEGACY Phase 3 trial, potentially accelerating development and market access.

Tegoprubart yields 24-month eGFR edge: 71 vs 58 mL/min/1.73 m².
FDA Fast Track designated tegoprubart for kidney transplant rejection prevention.
LEGACY Phase 3 to start in Q4 2026; ~600 patients planned.
BESTOW extension: 90 patients through 18 months; 81 through 24 months.
No BPAR beyond 6 months on tegoprubart; 7 cases on tacrolimus.

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Eledon advances tegoprubart with FDA Fast Track and LEGACY Phase 3 plans

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