Nurix Initiates DAYBreak CLL-201 at 600 mg, Plans Phase 3 and 2026 Autoimmune IND

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Nurix will execute its DAYBreak CLL-201 Phase 2 study at 600 mg once daily and begin confirmatory Phase 3 DAYBreak CLL-306 in relapsed/refractory CLL. It targets a 2026 IND submission for a tablet formulation in autoimmune diseases and will advance IRAK4 and STAT6 degrader programs with Gilead and Sanofi.

1. Superior Efficacy of Bexobrutideg in B-Cell Malignancies

Nurix’s lead asset, bexobrutideg, has demonstrated an 83% objective response rate in relapsed or refractory chronic lymphocytic leukemia patients with a median of four prior therapies, including two complete responses (4.3%). The median progression-free survival of 22.1 months notably exceeds outcomes achieved by currently approved BTK inhibitors in similar patient populations. Preclinical studies show bexobrutideg’s potent degradation of both wild-type and clinically relevant BTK mutants, coupled with central nervous system penetration and no dose-limiting toxicities across tested doses, addressing critical unmet needs in patients who have failed prior BTK and BCL-2 inhibitor treatments.

2. Robust Financial Position Fuels Operations Through 2028

As of December 31, 2025, Nurix holds over $650 million in cash, cash equivalents and marketable securities, providing runway into 2028. This strong balance sheet underpins aggressive clinical development, including ongoing pivotal studies, and supports planned IND filings in autoimmune and inflammatory indications. The company’s capital position also enables advancement of partnered programs—such as the IRAK4 degrader with Gilead and STAT6 degrader with Sanofi—without near-term dilution, offering asymmetric upside for shareholders as multiple data readouts approach.

3. 2026 Strategic Objectives and Multiple Catalysts

In 2026, Nurix will execute its DAYBreak pivotal program for bexobrutideg, advancing the Phase 2 DAYBreak CLL-201 study and initiating the confirmatory Phase 3 DAYBreak CLL-306 trial to support global registration. The company plans to submit an IND for a new tablet formulation of bexobrutideg in autoimmune and inflammatory diseases and expects to report initial clinical data by year-end. Additional milestones include Phase 1 data from the Gilead-partnered IRAK4 degrader GS-6791 and advancement of the STAT6 degrader with Sanofi, leveraging the proprietary DEL-AI discovery platform to expand Nurix’s pipeline across oncology, immunology and inflammation.

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