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# Nurix Gets Orphan Status for Bexobrutideg
- URL: https://www.fdaweb.com/nurix-gets-orphan-status-for-bexobrutideg/
- Published: 2025-03-18T12:00:00.000Z
- Updated: 2026-09-14T14:55:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158842

FDA has granted Nurix Therapeutics an orphan drug designation for bexobrutideg (NX-5948) and its use in treating Waldenström macroglobulinemia (WM). Bexobrutideg is described by the company as an orally bioavailable, brain-penetrant degrader of BTK which is being evaluated in an ongoing Phase 1a/b clinical trial in adults with relapsed or refractory B-cell malignancies. “Targeted protein degraders are characterized by their bifunctional nature, binding to both a target protein and a ligase to drive ubiquitination and catalytic degradation of the target through the proteasome,” it says.

The designation is based on “encouraging safety and efficacy data” in patients with WM treated in the ongoing Phase 1a/b clinical trial that demonstrated “early promise of clinical benefit with potential for durable outcomes,” Nurix says. The trial continues to enroll patients with WM in the ongoing Phase 1b expansion cohort and the company expects to provide additional clinical data later this year.

WM is a rare, slow-growing type of non-Hodgkin’s lymphoma that is characterized by the replacement of normal bone marrow cells by malignant lymphocytic cells that produce monoclonal immunoglobulin M (IgM), the company says. “This replacement leads to anemia, bleeding, and impaired immune function, while the elevated IgM levels may cause neurologic symptoms,” it says.