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Investing.com -- Nurix Therapeutics Inc (NASDAQ:NRIX) stock surged 10% on Wednesday after the company announced the initiation of its pivotal DAYBreak clinical trial, a single-arm Phase 2 study of bexobrutideg in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
The clinical-stage biopharmaceutical company, focused on targeted protein degradation medicines, will evaluate a 600 mg once-daily dose in the DAYBreak study. This dosage was selected following analysis of data from a randomized cohort within the Phase 1b study, reflecting alignment with global regulators including the FDA, UK MHRA, and EMA.
"The initiation of the DAYBreak study marks Nurix’s transition to a pivotal-stage company and a major milestone for bexobrutideg, which our data demonstrate has a potential best-in-class profile," said Arthur T. Sands, M.D., Ph.D., president and CEO of Nurix.
The DAYBreak study will enroll CLL patients who have experienced disease progression following treatment with multiple inhibitors. The trial aims to generate data to support a potential Accelerated Approval submission, addressing an unmet medical need in this patient population.
Nurix also plans to initiate a randomized confirmatory Phase 3 trial in the first half of 2026 in CLL patients whose disease has previously progressed while receiving a covalent BTK inhibitor. This global trial will compare bexobrutideg monotherapy to an investigator’s choice of alternative treatments.
The company will provide additional program updates during an investor webcast today, including a review of new preclinical data supporting bexobrutideg’s potential best-in-class BTK degrader profile.
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