Clinical TrialAug 13, 2026, 04:07 PM
Eledon Pharmaceuticals to advance tegoprubart into Phase 3 kidney trial
AI Summary
Eledon Pharmaceuticals announced a successful End-of-Phase 2 meeting with the FDA for tegoprubart in kidney transplantation, supporting its advancement into a global Phase 3 trial expected to initiate in late 2026. Long-term Phase 2 BESTOW data demonstrated sustained higher kidney function and improved patient-reported outcomes, while updated islet cell transplantation data showed 100% insulin independence in all 12 patients with type 1 diabetes. The company reported $88.8 million in cash, cash equivalents, and short-term investments as of June 30, 2026, and a net loss of $31.6 million for the second quarter of 2026.
Key Highlights
- Successful End-of-Phase 2 meeting with FDA for tegoprubart in kidney transplantation.
- Global Phase 3 kidney transplantation trial on track to initiate in late 2026, enrolling ~600 patients.
- Phase 2 BESTOW data showed tegoprubart patients had 12 mL/min/1.73 m² higher eGFR at 18 months.
- Islet cell transplantation study showed 100% insulin independence in 12 T1D patients.
- Cash, cash equivalents, and short-term investments totaled $88.8 million as of June 30, 2026.
- Net loss for Q2 2026 was $31.6 million, or $0.27 per basic common share.
- R&D expenses for Q2 2026 were $18.2 million, compared to $20.3 million in Q2 2025.
- Company expects current cash to fund operations into the second quarter of 2027.
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