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confidence high
sentiment positive
materiality 0.85
Nurix initiates pivotal Phase 2 DAYBreak trial of bexobrutideg in r/r CLL with 600 mg QD dose
Nurix Therapeutics, Inc.
- DAYBreak Phase 2 will enroll ~100 r/r CLL/SLL patients after prior cBTKi, ncBTKi, and BCL-2i; primary endpoint is ORR by IRC.
- 600 mg QD dose selected via Phase 1b randomized cohort; aligned with FDA, MHRA, and EMA for accelerated approval pathway.
- Confirmatory Phase 3 trial planned for H1 2026 with ~400 patients comparing bexobrutideg to pirtobrutinib or chemoimmunotherapy.
- NX-1607 Phase 1a data showed disease control rate 49.3% in 82 patients; confirmed partial response in MSS colorectal cancer.
- Preclinical data presented claim superior degradation potency and selectivity across BTK mutations; investor webcast held Oct 22.