Nurix Therapeutics, Inc. (NRIX) Monday said that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its drug candidate bexobrutideg for the treatment of Waldenstrm macroglobulinemia (WM), a rare, slow growing type of non-Hodgkins lymphoma.
The orphan drug designation provides certain benefits, including tax credits for qualified clinical testing, waiver or partial payment of FDA application fees and seven years of market exclusivity, if approved.
Nurix had previously reported encouraging safety and efficacy data for bexobrutideg in patients with WM treated in the ongoing Phase 1a/b study. The company continues to enroll patients with WM in a Phase 1b expansion cohort and expects to share additional data this year.
Bexobrutideg is currently being evaluated in a Phase 1 study in adults with relapsed or refractory B-cell malignancies.
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