Eledon Pharmaceuticals (ELDN) Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary

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.