Nurix Targets Phase 3 DAYBreak CLL-306 Launch and 2026 Autoimmune IND Filing

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Nurix will complete Phase 2 DAYBreak CLL-201 and initiate Phase 3 DAYBreak CLL-306 for bexobrutideg in relapsed/refractory CLL to support global registration. It plans a 2026 IND filing for a bexobrutideg tablet in autoimmune indications and will advance IRAK4 and STAT6 degrader programs with Gilead and Sanofi.

1. Clinical Data Demonstrate Best-in-Class Potential

Nurix reported an 83% objective response rate and 4.3% complete response rate for bexobrutideg in relapsed/refractory CLL patients with a median of four prior lines of therapy. Responses deepened over time, delivering a median progression-free survival of 22.1 months. Safety was favorable, with no dose-limiting toxicities observed across all dose cohorts. Preclinical studies further confirmed superior BTK degradation potency, broad coverage of clinically relevant BTK mutations and high selectivity, supporting bexobrutideg’s potential to outperform existing therapies in B-cell malignancies.

2. Robust Financial Runway through 2028

Nurix ended 2025 with over $650 million in cash and marketable securities, funding operations comfortably through 2028. This strong balance sheet underpins aggressive clinical development across oncology and immunology programs. Management expects to leverage these resources to advance pivotal studies without the need for immediate capital raises, positioning the company to capture upside from multiple mid- and late-stage catalysts while maintaining financial flexibility.

3. 2026 Pipeline Milestones and Expansion Plans

In 2026, Nurix will execute its DAYBreak program, including the ongoing Phase 2 DAYBreak CLL-201 trial and the planned randomized Phase 3 DAYBreak CLL-306 study to support global registration. The company will also submit an IND for a tablet formulation of bexobrutideg in autoimmune and inflammatory indications and advance partnered programs: an IRAK4 degrader with Gilead Sciences and a STAT6 degrader with Sanofi. These developments, combined with the DEL-AI discovery platform driving additional internal and external collaborations, are expected to deliver multiple value inflection points throughout the year.

Sources

SG