Core Insights - Nurix Therapeutics reported a robust objective response rate (ORR) of 75.5% from the Phase 1 study of NX-5948 in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [1][4] - The company received PRIME designation from the European Medicines Agency and Fast Track designation from the U.S. FDA for NX-5948 in CLL and Waldenstrom's Macroglobulinemia [1][4] - Nurix is well-capitalized with cash and marketable securities totaling $609.6 million as of November 30, 2024 [1][16] Clinical Development - NX-5948 is being evaluated for the treatment of relapsed or refractory B-cell malignancies, including CLL and Waldenstrom's macroglobulinemia [4][6] - The Phase 1 clinical trial showed an increase in ORR to 84.2% with longer treatment duration [4] - The drug was well-tolerated across all tested doses, ranging from 50 to 600 mg daily [4] Regulatory Designations - NX-5948 received Fast Track designation from the U.S. FDA for two indications: r/r CLL/SLL and r/r Waldenstrom's Macroglobulinemia [4][6] - The European Medicines Agency granted PRIME designation for NX-5948 in CLL [4] Financial Performance - For the fiscal year ended November 30, 2024, Nurix reported total revenue of $54.5 million, a decrease from $77.0 million in the previous year [13] - Research and development expenses increased to $221.6 million for the fiscal year, up from $189.1 million in 2023 [14] - The net loss for the year was $193.6 million, compared to a net loss of $143.9 million in the prior year [16] Leadership Changes - John Northcott was appointed as Chief Commercial Officer, bringing extensive experience in commercial leadership, including the commercialization of the first marketed BTK inhibitor [1][9]
Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides a Corporate Update