Nurix Therapeutics Advances Bexobrutideg Towards Accelerated Approval in CLL, Targets Phase 3 Initiation by Mid-2026, and Reports $540.7M Cash Balance
Nurix Therapeutics reported its first quarter 2026 financial results, highlighting significant progress in its clinical pipeline, particularly for bexobrutideg. The company is actively enrolling patients in the pivotal Phase 2 DAYBreak CLL-201 study, aiming for Accelerated Approval in relapsed/refractory chronic lymphocytic leukemia (r/r CLL), and plans to initiate a confirmatory Phase 3 trial by mid-2026. Additionally, Nurix is expanding bexobrutideg's potential into inflammatory and autoimmune indications with a new tablet formulation, targeting a 2026 IND submission. With a strong balance sheet of $540.7 million, Nurix is well-positioned to advance its registrational programs and broader pipeline, including partnered degraders for IRAK4 and STAT6.
Key Highlights
- Nurix Therapeutics reported a strong financial position with $540.7 million on the balance sheet as of February 28, 2026.
- Enrollment is ongoing in the DAYBreak™ CLL-201 pivotal Phase 2 single-arm study (NCT07221500) for bexobrutideg in relapsed/refractory CLL, designed to support a potential Accelerated Approval submission.
- The company plans to initiate a global randomized confirmatory Phase 3 trial (DAYBreak CLL-306) by mid-2026 to support full approval, comparing once-daily bexobrutideg monotherapy to pirtobrutinib in r/r CLL patients.
- Nurix is targeting a 2026 IND submission for bexobrutideg in inflammatory and autoimmune indications, utilizing a new tablet formulation and supported by ongoing healthy volunteer studies (NCT06717269).
- Advancement continues for targeted protein degraders of IRAK4 in Phase 1 and STAT6 in IND-enabling studies, under strategic partnerships with Gilead and Sanofi, respectively.
- Updated data from the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) for bexobrutideg in B-cell malignancies are anticipated to be presented at upcoming medical meetings throughout 2026.