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Eledon Pharmaceuticals
Eledon Pharmaceuticals (ELDN) investor relations material
Eledon Pharmaceuticals Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary12 Feb, 2026
Clinical trial results and insights
Phase II BESTOW study met the non-inferiority margin for the composite endpoint, the approvable endpoint for phase III, with kidney function data outperforming standard of care in most aspects.
Subgroup analysis revealed imbalances in kidney quality, affecting endpoint achievement, but safety outcomes were notably superior, including significant reductions in tremors, infection rates, sepsis, delayed graft function, and cardiovascular events.
Acute rejection rates were higher in the tego arm early on, but all rejections occurred within the first 6 months, with none observed afterward; protocol adjustments are planned for phase III to address detection timing.
Long-term phase Ib data showed no acute rejections and 100% survival at 24 months, with stable or improving kidney function, supporting better long-term outcomes compared to standard of care.
Both tac and tego arms are being followed for long-term outcomes, with data to be shared with regulatory agencies.
Regulatory and development plans
Preparation for an end-of-phase II meeting with the FDA is underway, targeting late Q1 or early Q2, with phase III trial launch expected by year-end.
Phase III will be powered for the composite endpoint of patient and graft survival (PPAR), with a non-inferiority design.
Phase III will include formal patient-reported outcomes and quality of life measures as secondary endpoints, addressing gaps from previous studies.
Protocol improvements will focus on balancing immunosuppression management, including ATG and steroid dosing, to minimize bias and optimize outcomes.
Commercial outlook and market positioning
Previous launches in the space, such as Nulojix, faced challenges due to comparator choice, safety profile, and logistical issues, which are less relevant today due to improved infrastructure.
Tego is positioned as a potential new standard of care for all types of transplants, including allotransplant and xenotransplant, supported by ongoing clinical and preclinical studies.
How will Phase 3 design ensure balanced treatment?
What is the commercial strategy for islet cells?
Tegoprubart's regulatory path for xenotransplant
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Next Eledon Pharmaceuticals earnings date
Q4 202526 Mar, 2026
Eledon Pharmaceuticals
Next Eledon Pharmaceuticals earnings date
Q4 202526 Mar, 2026
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Frequently asked questions
Eledon Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company focused on developing therapies to treat autoimmune diseases, organ transplantation, and neurodegenerative disorders. The company’s lead program involves developing treatments that target CD40L, a key immune system pathway involved in immune response regulation. By modulating this pathway, Eledon aims to develop therapies that prevent organ transplant rejection and treat autoimmune conditions without the need for long-term immunosuppression. The company's innovative approach seeks to address significant unmet medical needs in these therapeutic areas. The company is headquartered in Irvine, California, and its shares are listed on the NASDAQ.
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