Clinical Development - Nurix anticipates initiating a suite of late-stage clinical studies for NX-5948 in 2025, including pivotal studies for chronic lymphocytic leukemia (CLL) and expanding its development in additional cancer indications and inflammatory diseases[1] - The Phase 1a/1b clinical trial of NX-5948 demonstrated a robust objective response rate (ORR) of 75.5% among 49 efficacy-evaluable patients with relapsed or refractory CLL, increasing to 84.2% with longer treatment duration[3] - NX-5948 received Fast Track Designation from the U.S. FDA and PRIME designation from the European Medicines Agency for both CLL and Waldenstrom's macroglobulinemia[2] - Nurix reinitiated enrollment in the NX-2127 Phase 1a/b trial after lifting a manufacturing-related clinical hold, focusing on aggressive lymphomas[6] - The NX-1607 program is advancing with plans to establish a Phase 1b monotherapy dose and share additional clinical data following dose selection[11] - Nurix plans to explore regulatory paths for NX-5948 in treating autoimmune cytopenias, including warm autoimmune hemolytic anemia (wAIHA), in 2025[11] - Nurix anticipates nominating a STAT6 degrader development candidate in the first half of 2025, with a potential licensing option decision for Sanofi triggered by the delivery of a development candidate data package[12] - Nurix plans to nominate at least one development candidate from its wholly owned degrader pipeline to advance to IND-enabling studies in 2025[12] Financial Position - Nurix ended fiscal year 2024 with an estimated $609.6 million in cash and investments, positioning the company to fund operations into the first half of 2027[9] - The estimated cash and investment amount is a preliminary, unaudited estimate subject to financial closing procedures as of November 30, 2024[13] - Nurix's future financial performance and ability to fund operating activities into the first half of 2027 are subject to various risks and uncertainties[14] Collaborations and Partnerships - Nurix's collaboration with Gilead resulted in a $15 million payment for extending their research term, contributing to a total of $22 million earned from strategic collaborations in 2024[9] - The company retains options for co-development, co-commercialization, and profit sharing in the U.S. for multiple drug candidates under collaboration agreements with Gilead Sciences, Sanofi, and Pfizer[12] Drug Discovery and Innovation - The company is expanding its DEL-AI discovery engine to create novel degrader-based treatments, leveraging AI-powered drug discovery[3] - Nurix's drug discovery platform is powered by a fully AI-integrated discovery engine capable of tackling any protein class, enhancing its competitive advantage[12] - Nurix aims to establish degrader-based treatments at the forefront of patient care, focusing on innovative drug design[12] - The company is advancing multiple potentially first-in-class or best-in-class degraders and DACs in its preclinical pipeline[12] Forward-Looking Statements - Forward-looking statements reflect Nurix's current beliefs and expectations, but actual results may differ materially due to risks and uncertainties[14]

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]

Mr. Northcott brings over 20 years of biopharmaceutical experience building commercial organizations and successfully commercializing novel products, including BTK inhibitor ibrutinibSAN FRANCISCO, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced the appointment of John Northcott as chief commercial officer (CCO). ...

Initiate a suite of clinical trials in 2025 intended to support global registration of NX-5948 for the treatment of chronic lymphocytic leukemia Expand the development of NX-5948 in additional cancer indications and inflammatory diseases Advance our portfolio of partnered programs in inflammation and immunology, including degraders of IRAK4 and STAT6 Invest in our highly productive DEL-AI discovery engine to create and advance novel degrader-based treatments in our wholly owned and partnered portfolios Main ...

Nurix Therapeutics, Inc. (NASDAQ: NRIX ) leads in targeted protein modulation with its proprietary DELigase platform. This way, it develops therapies for cancer and inflammatory conditions. NRIX offers solutions for challenging conditions resistant to conventional treatments, using the natural processesMy name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science from Ohio U ...

SAN FRANCISCO, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix, will present a corporate update at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 3:00 p.m. PT, in San Francisco. The event will be we ...

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]

Core Insights - Nurix Therapeutics has received Fast Track designation from the FDA for NX-5948, a selective BTK degrader, aimed at treating adult patients with relapsed or refractory Waldenstrom's macroglobulinemia after at least two lines of therapy, including a BTK inhibitor [1][2] - The Fast Track designation highlights the unmet medical need in Waldenstrom's macroglobulinemia, especially for patients whose cancer has progressed after BTK inhibitor therapy [2] - NX-5948 has also received Fast Track designation for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and PRIME designation from the EMA for the same indication [2] Company Overview - Nurix Therapeutics 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, which modulate protein levels within cells [8] - NX-5948 is currently in a Phase 1 clinical trial for relapsed or refractory B cell malignancies, demonstrating potency against tumor cell lines resistant to existing BTK inhibitors [6][8] Disease Context - Waldenstrom's macroglobulinemia is a rare type of non-Hodgkin's lymphoma with an incidence of approximately 0.36 to 0.57 per 100,000 people in the U.S., translating to about 1,200 to 1,900 new cases annually [3] - The disease is characterized by the production of monoclonal IgM, leading to anemia, bleeding, and impaired immune function, with no approved therapies for patients after BTK inhibitor treatment [3] Regulatory Designations - The FDA's Fast Track designation aims to expedite the development and review of drugs addressing serious conditions and unmet medical needs, allowing for more frequent interactions with the FDA [4] - The EMA's PRIME initiative provides early and enhanced support to developers of promising medicines, facilitating faster patient access [5]

Core Viewpoint - Nurix Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing targeted protein modulation drugs for cancer and inflammatory diseases, with a corporate update presentation scheduled at the Piper Sandler 36th Annual Healthcare Conference [1]. Company Overview - Nurix Therapeutics specializes in the discovery, development, and commercialization of innovative small molecules and antibody therapies that modulate cellular protein levels [3]. - The company utilizes an integrated discovery platform called DELigase, which focuses on identifying and advancing drug candidates targeting E3 ligases, a class of enzymes that modulate proteins within cells [3]. - Nurix's clinical stage pipeline includes targeted protein degraders of Bruton's tyrosine kinase and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, which are involved in immune cell regulation [3]. - The company is headquartered in San Francisco, California [3].

The PRIME initiative provides enhanced support to developers of promising medicines to optimize development plans and accelerate evaluation Pivotal trials of NX-5948 are planned to initiate in 2025 SAN FRANCISCO, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that the European Medicines Agency (EMA) has granted P ...