Nurix Therapeutics Receives U.S. FDA Fast Track Designation for NX-5948 for the Treatment of Relapsed or Refractory Waldenstrom’s Macroglobulinemia

Company Overview - Nurix Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing targeted protein modulation drugs for cancer and inflammatory diseases [8] - The company utilizes an integrated discovery platform called DELigase to identify and advance novel drug candidates targeting E3 ligases [8] Product Development - The FDA has granted Fast Track designation for NX-5948, a selective degrader of Bruton’s tyrosine kinase (BTK), for treating adult patients with relapsed or refractory Waldenstrom’s macroglobulinemia after at least two lines of therapy [1][2] - NX-5948 has previously received Fast Track designation for chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and has also been granted PRIME designation by the European Medicines Agency (EMA) for the same indications [2] Clinical Trials - Encouraging safety and efficacy data from the ongoing Phase 1 clinical trial of NX-5948 have been reported, showing early promise for clinical benefit and potential for durable outcomes [2] - The company continues to enroll patients in the Phase 1b expansion cohort and plans to share additional clinical data in 2025 [2] Market Context - Waldenstrom’s macroglobulinemia is a rare type of non-Hodgkin’s lymphoma with an incidence of approximately 1,200 to 1,900 cases annually in the U.S. [3] - There are currently no approved therapies for treating WM patients after BTK inhibitor therapy, highlighting the unmet medical need that NX-5948 aims to address [3]