European Medicines Agency Grants Bexobrutideg (NX-5948) Orphan Drug Designation for the Treatment of Lymphoplasmacytic Lymphoma, also Known as Waldenström Macroglobulinemia

Core Insights - Nurix Therapeutics, Inc. has received Orphan Drug Designation from the European Medicines Agency for bexobrutideg (NX-5948) aimed at treating lymphoplasmacytic lymphoma, highlighting the drug's potential in addressing significant unmet medical needs in this rare blood cancer [1][3][4] Company Overview - Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on developing targeted protein degradation medicines, which represent a new frontier in drug design for cancer and inflammatory diseases [6][7] - The company's pipeline includes degraders of Bruton's tyrosine kinase (BTK) and inhibitors of CBL-B, with ongoing collaborations with major pharmaceutical companies like Gilead Sciences, Sanofi, and Pfizer [6] Drug Development Progress - Bexobrutideg is currently undergoing a Phase 1a/b clinical trial for adults with relapsed or refractory B-cell malignancies, including Waldenström macroglobulinemia, with early safety and efficacy data showing promise for durable outcomes [5][6] - The drug has previously received Fast Track designation from the U.S. FDA for multiple indications, including treatment for Waldenström macroglobulinemia and chronic lymphocytic leukemia/small lymphocytic lymphoma [4][5] Regulatory Designation Benefits - The Orphan Drug Designation provides several incentives, including 10 years of market exclusivity in the EU upon approval, access to protocol assistance, eligibility for centralized marketing authorization, and significant reductions in regulatory fees [2]