nrix-202606110001549595false06/11/20261600 Sierra Point ParkwayBrisbaneCalifornia00015495952026-06-112026-06-11
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): June 11, 2026
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NURIX THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
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| Delaware | 001-39398 | 27-0838048 |
(State or Other Jurisdiction of Incorporation or Organization) | (Commission File Number) | (IRS Employer Identification No.) |
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1600 Sierra Point Parkway, Brisbane, California | | 94005 |
| (Address of Principal Executive Offices) | | (Zip Code) |
(415) 660-5320
(Registrant’s Telephone Number, Including Area Code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
___________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class | Trading symbol(s) | Name of each exchange on which registered |
| Common Stock, $0.001 par value per share | NRIX | Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 7.01 Regulation FD Disclosure.
On June 11, 2026, Nurix Therapeutics, Inc. (the “Company”) issued a press release announcing the presentation at the European Hematology Association Congress (“EHA2026”) of updated clinical data from from the Phase 1a/1b study of the Company’s novel Bruton's tyrosine kinase (BTK) degrader bexobrutideg (NX-5948) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
A copy of the press release, which includes the data to be presented at EHA2026, is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing. In addition, the information set forth under this Item 7.01, including Exhibit 99.1, shall not be deemed an admission as to the materiality of any information in this Current Report on Form 8-K.
Item 8.01 Other Events.
On June 11, 2026, the Company announced updated data from the Phase 1 clinical trial of bexobrutideg (NX-5948).
The updated data from the Phase 1a/1b study of bexobrutideg (NX-5948-301) in patients with CLL and SLL include safety findings across all CLL/SLL patients, updated safety findings for patients treated at the recommended Phase 2 dose (RP2D) of 600 mg once daily, updated Phase 1a results with extended follow-up, and new data from two Phase 1b cohorts evaluating bexobrutideg in earlier lines of treatment, including a cohort of BTK inhibitor (BTKi)-treated and BCL-2 inhibitor (BCL2i)-naïve patients and a cohort of BTKi-naïve patients, including treatment-naïve patients.
Phase 1a/1b safety findings and Phase 1a demographics
As of the January 1, 2026 data cutoff, the Phase 1a/1b safety population included 142 patients with CLL/SLL, including 86 patients treated at the 600 mg dose. Bexobrutideg was well tolerated across the Phase 1a/1b population, consistent with prior disclosures. The treatment-emergent adverse event (TEAE) profile was comparable between the overall patient population and patients receiving the 600 mg dose, with the most common TEAEs in patients including purpura/contusion, neutropenia, petechiae, diarrhea and fatigue. There were no dose-limiting toxicities. Three Grade 5 adverse events were reported, all of which were deemed not related to treatment.
The Phase 1a population had received a median of four prior lines of therapy (range = 2-12), including prior BTK inhibitors (97.9%), prior BCL2 inhibitors (83.3%) and prior non-covalent BTK inhibitors (27.1%). At baseline, many patients had mutations associated with BTK inhibitor resistance, including mutations in BTK (38.3%) and PLCG2 (14.9%). Poor prognostic features were common, including TP53 mutations (44.7%). Five patients (10.4%) in the Phase 1a population had central nervous system (CNS) involvement at baseline.
Phase 1a efficacy update
The updated Phase 1a data included 48 patients with relapsed or refractory CLL/SLL treated at starting dose levels ranging from 50 mg to 600 mg once daily, with a median follow-up of 22.4 months. Among the 47 response-evaluable patients, the objective response rate (ORR) was 83.0%, including two patients (4.3%) with a complete response, one patient (2.1%) with nodal partial response, and 36 patients (76.6%) with partial response. Six patients (12.8%) showed stable disease and two patients (4.3%) experienced progressive disease. Median progression-free survival was 22.1 months (95% Confidence Interval: 14.0 months to Not Reached). Clinical responses were observed across difficult-to-treat subgroups, including patients with BTK inhibitor resistance mutations, high-risk molecular features and CNS involvement.
Phase 1b earlier-line cohorts
The Phase 1b earlier-line cohorts include Cohort 5, which enrolled BTKi-treated and BCL2i-naïve patients, and Cohort 15, which enrolled BTKi-naïve patients, including treatment-naïve patients.
Cohort 5 enrolled 19 patients, 18 of whom remained on treatment as of the data cutoff. Among the 14 patients evaluable for response, the ORR was 92.9% with a median follow-up of 5.2 months.
Cohort 15 enrolled 20 patients, including 10 treatment-naïve patients, 19 of whom remained on treatment as of the data cutoff. Among the 19 patients evaluable for response, the ORR was 84.2% with a median follow-up of 4.9 months.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits
The following exhibits are filed or furnished, as applicable, herewith and this list is intended to constitute the exhibit index:
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| Exhibit No. | | Exhibit Title or Description |
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| 99.1 | | |
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| 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| NURIX THERAPEUTICS, INC. |
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Date: June 11, 2026 | By: | /s/ Christine Ring |
| | Christine Ring, Ph.D., J.D. |
| | Chief Legal Officer |
Document[Nurix Logo]
Nurix Therapeutics to Report Updated Phase 1a/b Results for BTK Degrader Bexobrutideg, Highlighting Durable Responses in Relapsed/Refractory CLL/SLL and Promising Activity in Earlier Lines of Therapy
High objective response rate of 92.9% in second line patients who have progressed on a BTK inhibitor and have not received BCL2 inhibitor treatment
Updated Phase 1a data further supports a median progression-free survival of 22.1 months and an objective response rate of 83% in heavily pretreated relapsed/refractory CLL/SLL patients
Bexobrutideg was well tolerated with longer follow-up demonstrating a safety profile consistent with prior disclosures
Responses observed across difficult-to-treat patient subgroups, including high-risk features, BTK resistance mutations and CNS involvement
Data to be presented at the 2026 European Hematology Association (EHA) Congress
BRISBANE, Calif., June 11, 2026 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, today announced updated clinical data from the Company’s ongoing NX-5948-301 Phase 1a/b clinical trial evaluating bexobrutideg (NX-5948), an investigational oral CNS-penetrant BTK degrader, in patients with chronic lymphocytic leukemia (CLL). The data will be presented during an oral presentation at the 2026 EHA Congress taking place June 11–14, 2026, in Stockholm, Sweden.
“These updated data continue to demonstrate the differentiated profile of bexobrutideg, including durable responses in heavily pretreated patients and encouraging activity in patients earlier in their treatment journey,” said Talha Munir, M.B. Ch.B., Ph.D., consultant hematologist at Leeds Teaching Hospitals NHS Trust and deputy chair of the United Kingdom National Cancer Research Institute CLL Study Group. “Importantly, responses were observed across patients with difficult-to-treat disease characteristics, including BTK inhibitor resistance mutations, high-risk molecular features and CNS involvement, while maintaining a favorable tolerability profile.”
“With longer follow-up in relapsed/refractory CLL and expansion into earlier-line treatment settings, we continue to see a consistent efficacy and safety profile for bexobrutideg,” said Paula O’Connor, M.D., chief medical officer of Nurix. “The durability of responses observed in heavily pretreated patients together with the promising activity seen in BCL2i-naïve and BTKi-naïve patients further support the broad potential of BTK degradation across all lines of therapy in CLL.”
“These latest findings continue to reinforce our belief that bexobrutideg has the potential to redefine BTK-directed therapy and emerge as a potentially best-in-class treatment for CLL,” said
Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix Therapeutics. “The updated data to be presented at EHA across Phase 1 cohorts continue to support the launch of a broad Phase 3 monotherapy program and strengthen the rationale for exploring the use of combination regimens in first- and second-line patients. We look forward to advancing these programs through our recently announced collaboration with Roche.”
Growing Safety Cohort Continues to Support Differentiated Profile
Across all Phase 1a/b CLL patients (n=142), bexobrutideg was well tolerated, consistent with prior disclosures, with safety findings generally comparable between patients treated at the 600 mg RP2D and the broader study population.
As of the January 1, 2026, data cutoff:
•No dose-limiting toxicities were observed
•No treatment-related Grade 5 adverse events were reported
•Treatment discontinuations due to adverse events occurred in only 5.6% of patients
•The most common treatment-emergent adverse events included purpura/contusion, neutropenia, petechiae, diarrhea, and fatigue.
Updated Phase 1a Data in Relapsed/Refractory CLL Continue to Support Durable Responses
The Phase 1a dose escalation study enrolled 48 patients with relapsed/refractory CLL/SLL treated with bexobrutideg at doses ranging from 50 mg to 600 mg once daily. Patients were heavily pretreated, having received a median of four prior lines of therapy (range 2–12), including prior BTK inhibitors (97.9%), prior BCL2 inhibitors (83.3%), and prior non-covalent BTK inhibitors (27.1%). Baseline high-risk features included BTK inhibitor resistance mutations (38.3%), TP53 mutations (44.7%), PLCG2 mutations (14.9%), and central nervous system (CNS) involvement (10.4%).
As of the January 1, 2026, data cutoff:
•Median follow-up was 22.4 months
•Median progression-free survival (PFS) was 22.1 months (95% CI: 14.0–NR)
•Objective response rate (ORR) was 83.0% (95% CI: 69.2–92.4)
•Responses included two complete responses, one nodal partial response, and 36 partial responses.
•Responses were observed across patients with BTK inhibitor resistance mutations, high-risk molecular features, and CNS involvement
Phase 1b Data Supports High ORR in Earlier-Line Cohorts
Nurix also presented new data from two of the Phase 1b cohorts evaluating bexobrutideg in earlier lines of treatment, including patients who had received prior BTKi treatment but were BCL2i-naïve (Cohort 5) and patients who were BTKi-naïve, including treatment-naïve patients (Cohort 15).
In Cohort 5 (n=19), patients had received prior BTK inhibitor therapy but no prior BCL2 inhibitor:
•ORR was 92.9% (95% CI: 66.1–99.8) among evaluable patients (n=14)
•18 of 19 patients remained on treatment at data cutoff
•Median follow-up was 5.2 months
•Five patients have not yet reached their first scan but remain on treatment
In Cohort 15 (n=20), which included BTKi-naïve and treatment-naïve patients:
•ORR was 84.2% (95% CI: 60.4–96.6) among evaluable patients (n=19)
•19 of 20 patients remained on treatment at data cutoff
•Median follow-up was 4.9 months
•Three patients with stable disease remain on treatment
About Bexobrutideg
Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant, highly selective small-molecule degrader of Bruton’s tyrosine kinase (BTK) being developed by Nurix and Roche as a potential best-in-class therapy across oncology, immunology and neurology.
Bexobrutideg is currently being evaluated in the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), and in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed or refractory B-cell malignancies. A new tablet formulation of bexobrutideg is also being evaluated in a first-in-human single-ascending-dose and multiple-ascending-dose study in healthy volunteers (NCT06717269) to support future development in immunology and neurology indications. Additional information about ongoing clinical trials can be found at clinicaltrials.gov.
About Nurix Therapeutics, Inc.
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and autoimmune diseases. Nurix’s wholly owned, clinical stage pipeline includes degraders of Bruton’s tyrosine kinase (BTK), a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B (CBL-B), an E3 ligase that regulates activation of multiple immune cell types including T cells and NK cells. Nurix also is advancing multiple potentially first-in-class or best-in-class degraders and degrader antibody conjugates (DACs) in its preclinical pipeline. Nurix’s partnered drug discovery pipeline consists of a preclinical stage degrader of STAT6, SAR448272/NX-3911, in collaboration with Sanofi, a clinical stage degrader of IRAK4, GS6791, in collaboration with Gilead, as well as multiple additional programs under collaboration agreements with Gilead Sciences, Inc., Sanofi S.A. and Pfizer Inc., within which Nurix retains certain options for co-development, co-commercialization and profit sharing in the United States for multiple drug candidates. Powered by an AI-integrated discovery engine capable of tackling virtually any protein class, and coupled with unparalleled ligase expertise, Nurix is headquartered in Brisbane, California. For additional information visit http://www.nurixtx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein that do not describe historical facts, including, but not limited to, statements regarding the broad potential of BTK degradation in CLL, the therapeutic potential of bexobrutideg, Nurix’s plans for the development of bexobrutideg, and any plans under and potential benefits of the Nurix-Roche collaboration, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others, (i) the unexpected emergence of adverse events or other undesirable side effects during preclinical and clinical development; (ii) whether Nurix will have adequate resources to fund its clinical and commercial obligations under the Nurix-Roche collaboration; (iii) risks and uncertainties related to regulatory review of the Nurix-Roche collaboration, including under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended; and (iv) the risks described under the heading “Risk Factors” in Nurix’s Quarterly Report on Form 10-Q for the period ended February 28, 2026, and subsequent filings with the SEC. Any of these risks and uncertainties could materially and adversely affect Nurix’s business and results of operations, which could, in turn, have a significant and adverse impact on Nurix’s stock price. Nurix cautions the reader not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Nurix undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made or to reflect the occurrence of unanticipated events.
Contacts:
Media & Investors
Kris Fortner
Nurix Therapeutics, Inc.
Kfortner@nurixtx.com