Regulatory2026-08-04

Bexobrutideg - (DAYBreak CLL-306)

Nurix Therapeutics Inc.NRIX
Indication
Relapsed or refractory chronic lymphocytic leukemia (CLL)
Stage
phase3
Event
Submission
Details

Aug. 4, 2026: Nurix Therapeutics (NASDAQ: NRIX) announced first-patient enrollment in the global Phase 3 DAYBreak CLL-306 trial (NCT07516093) of bexobrutideg (NX-5948), a BTK targeted protein degrader, in relapsed/refractory CLL/SLL after prior covalent BTK inhibitor treatment.

The registrational study, conducted with Roche, is the first Phase 3 trial for bexobrutideg and is designed to test superiority versus pirtobrutinib, described as the current standard of care in this setting. About 620 patients are expected to be randomized 1:1 to bexobrutideg 600 mg once daily or pirtobrutinib. Dual primary endpoints are independent review committee-assessed objective response rate and progression-free survival. The trial is intended to support global regulatory submissions.

The release also notes broader bexobrutideg development in CLL, including the pivotal single-arm Phase 2 DAYBreak CLL-201 study (NCT07221500), the Phase 1a/1b NX-5948-301 study (NCT05131022) in relapsed/refractory B-cell malignancies, and the planned/ongoing Phase 1/2 NX-5948-203 trial (NCT07520006) testing combinations with venetoclax with or without an anti-CD20 antibody in relapsed/refractory and treatment-naive CLL. A new tablet formulation is also being studied in healthy volunteers (NCT06717269) for future immunology and neurology development.