This section highlights FDA-related milestones and regulatory updates for drugs developed by Nurix Therapeutics (NRIX).
Over the past two years, Nurix Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
GS-6791/NX-0479 and NX-5948. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
GS-6791/NX-0479 - FDA Regulatory Timeline and Events
GS-6791/NX-0479 is a drug developed by Nurix Therapeutics for the following indication: Novel IRAK4 Degrader for Inflammatory Conditions.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- GS-6791/NX-0479
- Announced Date:
- April 17, 2025
- Indication:
- Novel IRAK4 Degrader for Inflammatory Conditions
Announcement
Nurix Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the IND for the IRAK4 degrader GS-6791/NX-0479
AI Summary
Nurix Therapeutics recently announced that the U.S. FDA has cleared the IND for its IRAK4 degrader GS-6791/NX-0479. This clearance allows the company, in collaboration with Gilead Sciences, to begin Phase 1 clinical trials in healthy volunteers during Q2 2025. GS-6791/NX-0479 is a selective, oral compound designed to degrade IRAK4, a key regulator of inflammatory pathways, and has shown rapid and potent activity in preclinical studies.
The preclinical results revealed that the drug achieved sustained IRAK4 degradation and cytokine suppression in relevant tissues, suggesting it may offer meaningful benefits for patients with inflammatory conditions such as rheumatoid arthritis and atopic dermatitis. The IND clearance represents a significant step forward in translating the promising laboratory findings into clinical potential for treating inflammation and autoimmune diseases.
Read Announcement- Drug:
- GS-6791/NX-0479
- Announced Date:
- April 17, 2025
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 2025
- Indication:
- Novel IRAK4 Degrader for Inflammatory Conditions
Announcement
Nurix Therapeutics, Inc. Phase 1 trial, which is anticipated to begin in Q2 2025.
AI Summary
Nurix Therapeutics announced that the FDA has cleared its Investigational New Drug (IND) application for GS-6791/NX-0479, an oral IRAK4 degrader. This clearance allows the company to start a Phase 1 clinical trial in healthy volunteers, which is expected to begin in Q2 2025. The trial will assess the safety and effects of single and multiple ascending doses of the drug. GS-6791/NX-0479 works by targeting IRAK4, a key protein in the inflammation process, and aims to reduce inflammatory responses associated with diseases like rheumatoid arthritis and atopic dermatitis. In preclinical studies, the drug showed rapid and sustained IRAK4 degradation in various cell types and animal models, suggesting it could offer enhanced treatment options for chronic inflammatory conditions. The study is part of Nurix’s broader program to develop innovative therapies for inflammatory and autoimmune diseases.
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NX-5948 - FDA Regulatory Timeline and Events
NX-5948 is a drug developed by Nurix Therapeutics for the following indication: Autoimmune Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NX-5948
- Announced Date:
- June 12, 2025
- Indication:
- Autoimmune Disease
Announcement
Nurix Therapeutics, Inc. announced positive clinical data from the Company's ongoing NX-5948-301 study, a Phase 1a/b clinical trial of bexobrutideg (NX-5948) in patients with relapsed or refractory B-cell malignancies.
AI Summary
Nurix Therapeutics, Inc. announced positive early clinical results from its ongoing NX-5948-301 trial. In this Phase 1a/b study, bexobrutideg (NX-5948) is showing promise for patients with relapsed or refractory B-cell malignancies, including chronic lymphocytic leukemia (CLL) and Waldenström macroglobulinemia (WM). The study reported an 80.9% overall objective response rate in CLL patients and an 84.2% response rate among WM patients, with some individuals achieving deep, meaningful responses and one patient with CLL reaching a complete response after over two years of treatment.
Bexobrutideg was well tolerated overall, with no new safety signals observed even with longer treatment durations and at higher doses. These encouraging results highlight Nurix’s strength in targeted protein degradation and lay the groundwork for the company to begin pivotal trials in 2025.
Read Announcement- Drug:
- NX-5948
- Announced Date:
- June 6, 2025
- Indication:
- Autoimmune Disease
Announcement
Nurix Therapeutics, Inc announced that the company will host a webcast conference call at 8:00 a.m., ET, on Thursday, June 12, 2025, to discuss new data from the ongoing Phase 1 clinical trial of bexobrutideg (NX-5948) that will be presented at the European Hematology Association Congress in Milan, Italy.
AI Summary
Nurix Therapeutics, Inc. will host a webcast conference call at 8:00 a.m. ET on Thursday, June 12, 2025, to highlight new data from the ongoing Phase 1 clinical trial of bexobrutideg (NX-5948). This investigational drug is an orally administered, brain-penetrant molecule designed to degrade Bruton’s tyrosine kinase (BTK), showing promise in producing rapid and durable responses in patients with relapsed or refractory blood cancers.
The trial findings, scheduled to be presented at the European Hematology Association Congress in Milan, Italy, mark a significant step for this potential cancer treatment. Interested parties can join the live webcast via the Investors section on Nurix’s website or participate by dialing the appropriate number provided. A replay of the presentation will also be accessible on the website for approximately 30 days after the event.
Read Announcement- Drug:
- NX-5948
- Announced Date:
- April 25, 2025
- Indication:
- Autoimmune Disease
Announcement
Nurix Therapeutics, Inc. announced multiple preclinical presentations at the American Association for Cancer Research (AACR) 2025 Annual Meeting supporting several programs, each with different drug targets for indications with central nervous system (CNS) involvement. The AACR Annual Meeting is being held from April 25-30, 2025, in Chicago, IL.
AI Summary
Nurix Therapeutics announced multiple preclinical presentations at the AACR 2025 Annual Meeting in Chicago, IL, which will take place from April 25-30, 2025. The company is showcasing several programs focused on different drug targets for indications involving the central nervous system (CNS). One key highlight is the presentation of preclinical data on bexobrutideg, a CNS-penetrant BTK degrader. This investigational molecule is notable for its efficiency, as a single molecule can degrade about 10,000 copies of BTK per hour. The data demonstrate bexobrutideg’s ability to reach the CNS and its potential to address brain tumors, including primary CNS lymphoma and conditions with CNS involvement. Additionally, other presentations will explore drug candidates targeting mutant BRAF and Aurora A kinase, underscoring Nurix’s innovative approach to overcoming challenges in treating CNS-related tumors.
Read Announcement- Drug:
- NX-5948
- Announced Date:
- March 25, 2025
- Indication:
- Autoimmune Disease
Announcement
Nurix Therapeutics, Inc announced that company scientists will present preclinical data from its proprietary DEL-AI platform and several degrader programs in two oral presentations and two poster presentations at the American Association for Cancer Research (AACR) 2025 Annual Meeting, which will be held from April 25-30, 2025, in Chicago, IL..
AI Summary
Nurix Therapeutics, Inc. announced that its scientists will share new preclinical data at the AACR 2025 Annual Meeting in Chicago, IL, from April 25-30, 2025. The company will present findings from its innovative DEL-AI platform and multiple degrader programs, supporting its drug discovery efforts with advanced machine learning techniques. This platform utilizes DNA encoded library screening to quickly generate promising drug candidates by identifying potential protein binders.
At the conference, Nurix will deliver two oral presentations and display two posters. One oral session will cover a proteome-wide screening technique using machine learning to search multi-billion compound libraries. Another will focus on selective, orally bioavailable Aurora A degraders for treating both pediatric and adult cancers. The poster sessions include data on NRX-0305, a BRAF degrader, and NX-5948, a brain-penetrant BTK degrader. These presentations highlight the company’s commitment to advancing targeted protein degradation therapies.
Read Announcement- Drug:
- NX-5948
- Announced Date:
- March 17, 2025
- Indication:
- Autoimmune Disease
Announcement
Nurix Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to bexobrutideg (NX-5948) for the treatment of Waldenström macroglobulinemia (WM).
AI Summary
Nurix Therapeutics announced that the FDA has granted Orphan Drug Designation for its investigational drug bexobrutideg (NX‑5948) for treating Waldenström macroglobulinemia (WM), a rare type of non‑Hodgkin lymphoma. This designation is a significant milestone, as it recognizes the potential of bexobrutideg to meet the unmet medical needs of WM patients. The drug is a first‑in‑class, orally bioavailable, and brain‑penetrant Bruton’s tyrosine kinase (BTK) degrader. Unlike traditional inhibitors, bexobrutideg uses a unique degradation mechanism, which may allow it to eliminate the entire function of BTK even in cases where mutations render other drugs ineffective.
The Orphan Drug Designation also brings benefits such as tax credits, fee waivers, and up to seven years of market exclusivity if approved, bolstering Nurix’s strategy to offer a promising new therapeutic option for patients with relapsed or refractory B‑cell malignancies.
Read Announcement- Drug:
- NX-5948
- Announced Date:
- January 13, 2025
- Indication:
- Autoimmune Disease
Announcement
Nurix Therapeutics, Inc. today outlined key objectives and anticipated milestones for 2025, which will be the subject of Nurix's corporate update at the 43rd Annual J.P. Morgan Healthcare Conference today at 3:00 p.m. PT, in San Francisco.
AI Summary
Nurix Therapeutics, Inc. has unveiled its key objectives and anticipated milestones for 2025 during a corporate update at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, scheduled for 3:00 p.m. PT. The company plans to initiate a suite of pivotal clinical trials for NX-5948 aimed at supporting global registration for the treatment of chronic lymphocytic leukemia (CLL). Additionally, Nurix will work on expanding the use of NX-5948 into other oncological indications and inflammatory diseases, while also advancing its partnering programs in inflammation and immunology.
Other highlights include the development of a robust preclinical pipeline and investment in its DEL-AI discovery engine to identify new degrader-based treatments. These efforts are supported by a strong financial position, enabling the company to pursue innovative approaches toward targeted protein degradation in clinical settings.
Read Announcement- Drug:
- NX-5948
- Announced Date:
- December 19, 2024
- Indication:
- Autoimmune Disease
Announcement
Nurix Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for NX-5948, a highly selective degrader of Bruton's tyrosine kinase (BTK), for the treatment of adult patients with relapsed or refractory Waldenstrom's macroglobulinemia (WM) after at least two lines of therapy, including a BTK inhibitor.
AI Summary
Nurix Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its drug NX-5948. This designation is for the treatment of adult patients with relapsed or refractory Waldenstrom's macroglobulinemia (WM) who have already undergone at least two lines of therapy, including treatment with a BTK inhibitor.
The Fast Track status by the FDA is aimed at expediting the development and review process for drugs that address serious conditions with unmet medical needs. The designation for NX-5948 recognizes the need for new treatment options for WM patients, especially those whose disease has progressed after BTK inhibitor therapy. Early safety and efficacy data from an ongoing Phase 1 clinical trial show promise, and further data are expected to be released in 2025.
Read Announcement- Drug:
- NX-5948
- Announced Date:
- December 9, 2024
- Indication:
- Autoimmune Disease
Announcement
Nurix Therapeutics, Inc. today presented new positive clinical data from patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) treated in the Phase 1a/1b clinical trial of its Bruton's tyrosine kinase (BTK) degrader NX-5948.
AI Summary
Nurix Therapeutics recently shared positive clinical findings from its Phase 1a/1b trial of NX-5948, an oral Bruton's tyrosine kinase (BTK) degrader, in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The trial results, presented at the ASH Annual Meeting, revealed an impressive initial objective response rate (ORR) of 75.5%, which increased to 84.2% in patients with at least two disease assessments. These outcomes were achieved even in a heavily pre-treated population that included patients with poor prognostic genetic mutations and central nervous system involvement. Moreover, NX-5948 demonstrated a deepening and durable therapeutic response over time while maintaining a favorable safety profile across all doses, making it a promising candidate for future pivotal trials targeting this challenging patient group.
Read Announcement- Drug:
- NX-5948
- Announced Date:
- December 2, 2024
- Indication:
- Autoimmune Disease
Announcement
Nurix Therapeutics, Inc. announced that the company will host a live webcast to review new clinical data from the ongoing Phase 1a/1b clinical trial of its Bruton's tyrosine kinase (BTK) degrader program NX-5948, and provide a corporate update, at 8:15 p.m. PT (11:15 p.m. ET) on Monday, December 9, 2024.
AI Summary
Nurix Therapeutics, Inc. will host a live webcast on Monday, December 9, 2024, at 8:15 p.m. PT (11:15 p.m. ET) to present new clinical data from the ongoing Phase 1a/1b trial of its BTK degrader NX-5948. During the event, guest speaker Dr. Nirav N. Shah, a clinical study investigator and Associate Professor at the Medical College of Wisconsin, will review findings in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In addition to the trial update, Nurix’s leadership—including CEO Dr. Arthur T. Sands, CMO Dr. Paula G. O’Connor, and Chief Scientific Officer Gwenn M. Hansen—will share a corporate update and outline plans for the further development of NX-5948 in both oncology and autoimmune disease indications. The live webcast will be available on the Nurix website, with an archived replay provided for later viewing.
Read Announcement- Drug:
- NX-5948
- Announced Date:
- November 17, 2024
- Indication:
- Autoimmune Disease
Announcement
Nurix Therapeutics, Inc. announced the presentation of preclinical data, including mechanism of action and relevant disease models, from two pipeline programs: NX-5948 and GS-6791.
AI Summary
Nurix Therapeutics recently presented preclinical data for two key pipeline programs: NX-5948 and GS-6791. The data highlighted how these drugs work and their effectiveness in relevant disease models. NX-5948 is an orally available, brain-penetrant BTK degrader that shows promise not only for B-cell cancers but also for inflammatory and autoimmune conditions. Its mechanism works by degrading BTK, a protein involved in immune cell signaling, which may suppress inflammation more effectively than current BTK inhibitors.
GS-6791, developed in collaboration with Gilead Sciences, is designed to selectively degrade IRAK4, a protein that plays a critical role in inflammatory signaling processes. The preclinical studies demonstrated that GS-6791 robustly reduces inflammatory responses in disease models, suggesting it could be a strong candidate for treating rheumatoid arthritis and other inflammatory diseases. These findings emphasize Nurix’s innovative approach using its DELigase platform to develop next-generation therapies.
Read Announcement- Drug:
- NX-5948
- Announced Date:
- October 9, 2024
- Indication:
- Autoimmune Disease
Announcement
Nurix Therapeutics, Inc. announced that preclinical data will be presented from NX-5948, Nurix's proprietary BTK degrader currently in Phase 1b development for B-cell malignancies and in IND enabling studies for autoimmune disease, and GS-6791/NX-0479, an IRAK4 degrader discovered in collaboration with Gilead Sciences and also in IND-enabling studies, in two posters at ACR Convergence 2024, the annual meeting of the American College of Rheumatology (ACR), being held November 14–19, 2024, in Washington, D.C.
AI Summary
Nurix Therapeutics, Inc. announced that it will present new preclinical data at ACR Convergence 2024 in Washington, D.C., from two promising drug candidates. The company will share early findings on NX-5948, its proprietary BTK degrader, which is currently in Phase 1b trials for B-cell malignancies and undergoing IND-enabling studies for autoimmune diseases. Preclinical results indicate that NX-5948 may deeply suppress important immune signaling pathways, potentially benefiting treatments for arthritis and other inflammatory conditions.
Additionally, Nurix will feature data on GS-6791/NX-0479, an IRAK4 degrader discovered in collaboration with Gilead Sciences that is also in IND-enabling studies. This compound has shown promise in inhibiting key inflammatory signals linked to arthritis. The data will be presented in two separate poster sessions during the meeting, highlighting Nurix’s commitment to advancing innovative therapies for cancers and inflammatory diseases.
Read Announcement- Drug:
- NX-5948
- Announced Date:
- June 16, 2024
- Indication:
- Autoimmune Disease
Announcement
Nurix intends to advance NX-5948 into pivotal trial(s) in 2025
AI Summary
Nurix Therapeutics announced promising data from its Phase 1a/b trial of NX-5948, an oral BTK degrader, in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In this heavily pretreated group, an impressive objective response rate of 69.2% was observed, with many patients experiencing rapid and deepening responses over time. The treatment was well tolerated, with manageable side effects including purpura, thrombocytopenia, and neutropenia. Building on these encouraging results, the company plans to expand the trial across various CLL subpopulations. Importantly, Nurix intends to advance NX-5948 into pivotal, registration-directed clinical trial(s) in 2025. These upcoming studies aim to further confirm the safety and effectiveness of NX-5948 as a promising new treatment option for patients with challenging CLL cases.
Read Announcement- Drug:
- NX-5948
- Announced Date:
- June 16, 2024
- Indication:
- Autoimmune Disease
Announcement
Nurix Therapeutics, Inc.
AI Summary
Nurix Therapeutics, a clinical stage biopharmaceutical company, recently shared promising Phase 1a/b clinical data for its investigational BTK degrader, NX-5948. This oral drug is designed to help patients with challenging B-cell malignancies like chronic lymphocytic leukemia (CLL). In a heavily pretreated patient group, including many with prior resistance to BTK inhibitors, the study showed an objective response rate of 69.2%. Patients experienced rapid improvements, with positive responses seen as early as eight weeks and deeper responses emerging over time. With a favorable safety profile and manageable side effects, Nurix is optimistic about the potential of NX-5948 to address resistant forms of CLL. The company plans to expand its Phase 1b clinical trial and aims to initiate pivotal, registration-directed trials in 2025. Nurix will further discuss these developments during its webcast conference on June 16, 2024.
Read Announcement
