Nurix Therapeutics(NRIX)
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Nurix Therapeutics(NRIX.US)股价大涨!旗下BTK降解剂bexobrutideg获积极试验数据
智通财经网· 2025-12-09 02:37
Core Insights - Nurix Therapeutics reported positive trial data for its drug bexobrutideg in treating blood cancers, leading to an 18.68% stock increase to $21.47 [1] Group 1: Clinical Trial Results - In a Phase 1a trial for R/R chronic lymphocytic leukemia (CLL), bexobrutideg achieved an objective response rate (ORR) of 83% among 47 evaluable patients, with a median progression-free survival of 22.1 months and a median duration of response of 20.1 months [1] - In a Phase 1 trial for patients with Waldenström's macroglobulinemia (WM), the ORR was 75% among 28 evaluable patients, with indications of durable and deepening responses over time [2] Group 2: Drug Development and Mechanism - Nurix Therapeutics focuses on discovering and developing oral small molecule therapies aimed at regulating cellular protein levels for cancer and immune diseases [2] - The company is developing targeted protein degraders for Bruton's tyrosine kinase (BTK) and inhibitors for Casitas B cell lymphoma proto-oncogene-B (CBL-B), which regulates T cell activation [2][3] - BTK inhibitors are crucial for treating various B cell blood cancers, but resistance to these inhibitors highlights the need for alternative strategies, such as targeted protein degradation [3] Group 3: Analyst Ratings and Market Outlook - Investment bank Needham reiterated a "Buy" rating for Nurix Therapeutics with a target price of $26, expressing confidence in the company's market prospects [3] - Truist initiated a "Buy" rating with a target price of $30, while BTIG maintained a "Buy" rating with a target price of $27 [3] - The average target price from 17 analysts for Nurix Therapeutics is $27.18, with a high of $41 and a low of $15 [3]
Nurix Therapeutics (NasdaqGM:NRIX) Update / Briefing Transcript
2025-12-09 02:17
Nurix Therapeutics (NasdaqGM:NRIX) Conference Call Summary Company Overview - Nurix Therapeutics is focused on developing innovative therapies for patients with chronic lymphocytic leukemia (CLL) and other diseases, particularly through targeted protein degradation [1][2] Key Points on Bexabrutadeg (BexDeg) - **Product Definition**: Bexabrutadeg is a best-in-class BTK (Bruton’s tyrosine kinase) degrader, recognized for its unique pharmacology and potential to overcome resistance mutations associated with existing BTK inhibitors [2][4] - **Clinical Efficacy**: - Achieved an **83% overall response rate** in heavily pretreated CLL patients, with a **median progression-free survival (PFS)** of **22.1 months** [10][36] - Demonstrated efficacy against various resistance mutations, outperforming traditional BTK inhibitors [5][10] - Notably, **96% disease control rate** in a challenging patient population [32] - **Safety Profile**: - Treatment-related adverse events were reported in **75%** of patients, with a low incidence of severe events [25][26] - No grade 5 toxicities or dose-limiting toxicities (DLTs) were observed, indicating a favorable safety profile [25][50] - **Mechanism of Action**: - Bexabrutadeg can degrade up to **10,000 BTK proteins per hour**, showcasing its catalytic nature and differentiating it from traditional inhibitors [8] - It addresses both the kinase and scaffolding functions of BTK, providing a significant therapeutic advantage [6][7] Pipeline and Future Development - **Clinical Trials**: - Initiated the **Daybreak series of trials** aimed at accelerated approval, with plans for randomized confirmatory trials [11][12] - Future studies will explore combination therapies with other agents, including venetoclax [60][61] - **Regulatory Approvals**: - Bexabrutadeg has received approval from the FDA, EMA, and MHRA, marking a significant milestone for Nurix [52][53] - **Market Potential**: - The company anticipates a high economic value for Bexabrutadeg, given the significant patient populations in the U.S. and Canada that can benefit from this therapy [12] Waldenstrom's Macroglobulinemia Data - **Patient Population**: - The study included **31 patients** with Waldenstrom's, with a median age of **71** and a high prevalence of previous BTK inhibitor exposure [42][43] - **Efficacy Results**: - The objective response rate was **75%**, with a major response rate of **60%** [47][50] - Responses were observed even in patients with CNS involvement, indicating the drug's potential in difficult-to-treat populations [49] - **Safety Profile**: - Similar to CLL, most treatment-related adverse events were low-grade and manageable, with no new safety concerns identified [45][50] Competitive Landscape - **Comparison with Pirtobrutinib**: - Bexabrutadeg's objective response rates and durability of response are superior to those reported for Pirtobrutinib, highlighting its potential as a more effective treatment option [56][57] Conclusion - Nurix Therapeutics is positioned as a significant player in the oncology space with Bexabrutadeg, demonstrating promising clinical efficacy and safety in CLL and Waldenstrom's macroglobulinemia. The company is advancing its clinical programs and exploring combination therapies to enhance treatment outcomes for patients with hematologic malignancies [54][62]
Paramount Skydance, Wave Life Sciences, Ocular Therapeutix, Carvana And Other Big Stocks Moving Higher On Monday - Arcellx (NASDAQ:ACLX), Arrowhead Pharma (NASDAQ:ARWR)
Benzinga· 2025-12-08 17:33
Group 1 - U.S. stocks experienced a decline, with the Dow Jones falling over 200 points on Monday [1] - Paramount Skydance Corporation launched an all-cash tender offer to acquire Warner Bros. Discovery, Inc. for $30 per share, valuing the company at $108.4 billion [1] - Paramount aims to create a scaled Hollywood leader by merging with Warner Bros. [1] Group 2 - Paramount Skydance shares increased by 9.8% to $14.68 on Monday [2] - Other notable stocks that gained include Wave Life Sciences Ltd., which rose 129.1% to $17.16 after positive interim Phase 1 data for its obesity drug [4] - Structure Therapeutics Inc. saw a gain of 100.5% to $69.30 following the announcement of topline data from its clinical program for obesity treatment [4] Group 3 - Fulcrum Therapeutics, Inc. shares rose 62.3% to $14.44 after reporting initial results from its Phase 1b trial for sickle cell disease [4] - Kymera Therapeutics, Inc. gained 51.2% to $100.75 after reporting successful trial results for its KT-621 drug [4] - Confluent, Inc. shares increased by 29.2% to $29.89 after IBM agreed to acquire the company for $31 per share [4]
Morning Market Movers: CETX, TGL, TWG, FULC See Big Swings
RTTNews· 2025-12-08 13:20
Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Cemtrex, Inc. (CETX) has increased by 284% to $11.79 - Treasure Global Inc. (TGL) has risen by 135% to $59.83 - Top Wealth Group Holding Limited (TWG) is up 95% at $11.73 - Fulcrum Therapeutics, Inc. (FULC) has gained 49% to $13.29 - MetaVia Inc. (MTVA) is up 33% at $10.90 - Kymera Therapeutics, Inc. (KYMR) has increased by 31% to $87.58 - Confluent, Inc. (CFLT) is up 27% at $29.40 - Immix Biopharma, Inc. (IMMX) has risen by 23% to $6.85 - Nurix Therapeutics, Inc. (NRIX) is up 18% at $21.46 - SU Group Holdings Limited (SUGP) has increased by 15% to $6.44 [3] Premarket Losers - SMX (Security Matters) Public Limited Company (SMX) has decreased by 27% to $242.01 - Meihua International Medical Technologies Co., Ltd. (MHUA) is down 27% at $10.20 - Polyrizon Ltd. (PLRZ) has declined by 16% to $10.90 - Fly-E Group, Inc. (FLYE) is down 16% at $6.90 - Sensei Biotherapeutics, Inc. (SNSE) has decreased by 14% to $8.29 - Kentucky First Federal Bancorp (KFFB) is down 10% at $4.00 - Arteris, Inc. (AIP) has declined by 7% to $16.27 - Fusion Fuel Green PLC (HTOO) is down 6% at $3.89 - Kamada Ltd. (KMDA) has decreased by 5% to $6.69 - iOThree Limited (IOTR) is down 5% at $3.11 [4]
Nurix Therapeutics Presents New Data from the Phase 1 Trial of Bexobrutideg (NX-5948) in Waldenström Macroglobulinemia at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition
Globenewswire· 2025-12-08 13:00
Core Insights - Nurix Therapeutics presented new clinical data for bexobrutideg, a BTK degrader, showing an objective response rate (ORR) of 75.0% in heavily pre-treated Waldenström macroglobulinemia patients [1][4] - The drug demonstrated durable responses and was well tolerated, with no dose-limiting toxicities reported [2][3] - The company aims to position bexobrutideg as a best-in-class therapeutic option for various hematological malignancies [2] Clinical Data Summary - The Phase 1 trial included 31 patients with a median age of 71 years and a median of 3 prior lines of therapy [2][4] - Among the patients, 77.4% had MYD88 mutations and 19.4% had CXCR4 mutations, with 100% having prior BTK inhibitor treatment [2] - The ORR included very good partial responses (VGPR) in 10.7% of patients, partial responses (PR) in 50.0%, and minor responses (MR) in 14.3% [4] Safety and Tolerability - Bexobrutideg was well tolerated, with common adverse events being low grade, including neutropenia (29.0%) and diarrhea (25.8%) [3] - No new onset atrial fibrillation was observed, and only two treatment-emergent adverse events led to drug discontinuation [3] Future Development - The company plans to expand the development of bexobrutideg into chronic lymphocytic leukemia (CLL) and other non-Hodgkin lymphoma (NHL) indications [2][8] - Nurix is also advancing multiple other drug candidates in its pipeline, focusing on targeted protein degradation [9]
Nurix Therapeutics (NasdaqGM:NRIX) FY Conference Transcript
2025-12-03 18:32
Summary of Nurix Therapeutics FY Conference Call Company Overview - **Company**: Nurix Therapeutics (NasdaqGM:NRIX) - **Focus**: Development of targeted protein degrader drugs, primarily in oncology and autoimmune diseases [3][4] Pipeline and Key Products - **Lead Program**: Bexobrutadeg (formerly NX5948), a targeted protein degrader of BTK, currently in pivotal studies for Chronic Lymphocytic Leukemia (CLL) [3][4] - **Upcoming Trials**: Phase 3 randomized confirmatory trial for Bexobrutadeg planned to start in the first half of 2026 [3][4] - **Safety Profile**: Over 200 patients treated, showing a favorable safety profile and potential applications in autoimmune diseases [4] - **Additional Products**: - STAT6 degrader (NX3911) developed in collaboration with Sanofi, currently in IND enabling studies [5][26] - IRAK4 degrader in collaboration with Gilead, currently in phase one [5][31] Competitive Advantages of Bexobrutadeg - **Mechanism**: Unlike traditional BTK inhibitors, Bexobrutadeg completely removes the BTK protein, addressing both kinase and scaffolding functions [6][7] - **Efficacy**: Higher efficacy and ability to address resistance mutations compared to existing BTK inhibitors [7][10] - **Selectivity**: Bexobrutadeg shows a 64-fold selectivity against TEC, reducing potential cardiovascular side effects [11][12] Upcoming Data Presentations - **ASH Meeting**: Presentations on CLL and Waldenström's macroglobulinemia, focusing on duration of effect and progression-free survival [13][14] - **Subgroup Analyses**: First-time presentation of subgroup analyses based on mutations and prior treatments [15][16] Market Opportunity - **CLL Market Size**: Estimated at $9.5 billion annually for BTK targeted agents, with significant opportunities in second-line and third-line treatments [21][22] - **Patient Numbers**: Approximately 10,000 new patient prescriptions annually in the second line and 6,000 in the third line in the U.S. [21] Future Directions - **Combination Trials**: Plans to explore combination therapies with BCL-2 inhibitors and anti-CD20 agents in both second-line and front-line settings [22][23] - **Autoimmune Indications**: Investigating potential applications in multiple sclerosis (MS) and other inflammatory disorders [23][24] Collaborations and Partnerships - **Sanofi**: Collaboration on STAT6 degrader, with potential IND filing in 2026 [26][27] - **Gilead**: Partnership on IRAK4 program, with phase 1 data expected in 2026 [31] Conclusion - Nurix Therapeutics is positioned to leverage its innovative degrader platform to address significant unmet needs in oncology and autoimmune diseases, with a robust pipeline and strategic collaborations enhancing its market potential [3][4][5]
Nurix Therapeutics Announces Webcast to Review New and Updated Data from the Phase 1 Clinical Trial of BTK Degrader Bexobrutideg (NX-5948) To Be Presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition
Globenewswire· 2025-12-01 12:00
Core Insights - Nurix Therapeutics, Inc. is set to host a live webcast on December 8, 2025, to present new clinical data from its ongoing Phase 1a/1b trial of bexobrutideg, a BTK degrader program, along with a corporate update [1][2] Company Overview - Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on developing targeted protein degradation medicines for oncology and autoimmune diseases [5] - The company’s pipeline includes BTK degraders and CBL-B inhibitors, with ongoing collaborations with major pharmaceutical companies like Sanofi and Gilead [5] Clinical Trial Information - Bexobrutideg (NX-5948) is currently being evaluated in the DAYBreak CLL-201 clinical trial, a pivotal Phase 2 study for patients with relapsed or refractory chronic lymphocytic leukemia [4] - The NX-5948-301 Phase 1a/1b trial is also ongoing for patients with relapsed or refractory B cell malignancies [4] Webcast Details - The webcast will feature presentations from key figures including Dr. Alvaro Alencar and Dr. Arthur T. Sands, discussing clinical data and Nurix's development strategy [2][3]
Nurix Therapeutics to Participate in the Piper Sandler 37th Annual Healthcare Conference
Globenewswire· 2025-11-25 12:00
Core Insights - Nurix Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on targeted protein degradation medicines for oncology and autoimmune diseases [3] Company Overview - Nurix's pipeline includes degraders of Bruton's tyrosine kinase (BTK) and inhibitors of Casitas B-lineage lymphoma proto-oncogene B (CBL-B) [3] - The company is advancing multiple potentially first-in-class or best-in-class degraders and degrader antibody conjugates (DACs) in its preclinical pipeline [3] - Nurix has partnered with Gilead, Sanofi, and Pfizer for drug discovery, retaining options for co-development and profit sharing in the U.S. [3] - The company utilizes an AI-integrated discovery engine and has expertise in ligase to enhance its clinical advancements [3] Upcoming Events - Arthur T. Sands, M.D., Ph.D., and Hans van Houte will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025 [1] - The event will be webcast live and archived for 30 days [2]
Nurix Therapeutics (NasdaqGM:NRIX) 2025 Conference Transcript
2025-11-19 12:02
Summary of Nurix Therapeutics Conference Call Company Overview - **Company**: Nurix Therapeutics (NasdaqGM:NRIX) - **Event**: Jefferies London Healthcare Conference 2025 - **Date**: November 19, 2025 Key Points Industry and Product Focus - Nurix Therapeutics is focused on developing therapies for Chronic Lymphocytic Leukemia (CLL) and other indications using their BTK degrader platform, specifically Bexobrutideg and NX-5948 [3][4][5] Upcoming Events and Data Releases - The company will present data at the upcoming ASH conference, including follow-up data from Phase 1A and Phase 1B trials for Bexobrutideg and NX-5948 [3][4] - Key metrics to be reported include duration of therapy and duration of response, with patients having been on therapy for over two years [3][4] Pivotal Trial Design - The pivotal trial for Bexobrutideg will focus on a triple-exposed patient population in CLL, with a selected dose of 600 mg once daily based on Phase 1B data [4][6] - The trial aims for accelerated approval, allowing early market access, while full approval will follow a randomized control study [10][11] Competitive Landscape - The company anticipates competition from pirtobrutinib, a non-covalent BTK inhibitor from Eli Lilly, which is expected to gain full approval [8][10] - Nurix is positioning Bexobrutideg as a potential standard of care in the U.S. market for CLL [10] Combination Therapies - Nurix is planning combination studies with Bexobrutideg and other therapies, including venetoclax and anti-CD20 antibodies [22][23] - The company is also exploring the potential of combining with T-cell engagers [23] Autoimmune Indications - The company is developing Bexobrutideg for autoimmune diseases, leveraging its ability to degrade BTK, which may provide advantages over traditional inhibitors [26][27] - A new formulation for Bexobrutideg is in development, with plans for IND submission in 2026 [27] Partnerships and Pipeline - Nurix has partnerships with Gilead for an IRAK4 degrader and with Sanofi for a STAT6 degrader, both of which are in various stages of development [35][36] - The IRAK4 program is in Phase 1, while the STAT6 program is in IND enabling studies [35][36] Financial Position - Nurix recently raised $250 million, bringing total cash reserves to over $650 million, providing a strong financial runway through early 2028 [41][42] Future Considerations - The company is preparing for multiple decisions regarding its partnerships and potential opt-ins based on upcoming clinical data [38][41] Conclusion - Nurix Therapeutics is strategically positioned in the biotech space with a focus on innovative therapies for CLL and autoimmune diseases, backed by a strong financial position and promising clinical data on the horizon [41][42]
Nurix Therapeutics (NasdaqGM:NRIX) 2025 Conference Transcript
2025-11-13 15:20
Summary of Nurix Therapeutics Conference Call Company Overview - **Company**: Nurix Therapeutics (NasdaqGM:NRIX) - **Focus**: Targeted protein degradation, primarily in oncology and inflammation Key Points Industry and Product Development - Nurix is pioneering targeted protein degradation as a new therapeutic modality, starting with Chronic Lymphocytic Leukemia (CLL) [2][3] - The lead product, Bexobrutideg (Bexdeg), targets BTK, a validated drug target, and has shown an 80% response rate in CLL patients who have undergone four prior lines of therapy [2][3] Clinical Trials and Efficacy - Initiated pivotal trials for Bexdeg in CLL, with a focus on a triple-exposed patient population (patients treated with covalent BTK inhibitors, BCL-2 inhibitors, and non-covalent BTK inhibitors) [9][10] - The 600 mg dose of Bexdeg is expected to provide better coverage against resistance mutations and improve overall efficacy and progression-free survival [6][39] - The confirmatory phase III trial is designed to assess superiority over standard care, with a focus on global enrollment strategies [30][29] Regulatory Considerations - Discussions with the FDA regarding the appropriateness of the triple-exposed patient population for accelerated approval are ongoing, with a target follow-up duration of about one year [12][17] - The accelerated approval paradigm is under scrutiny, with Nurix confident in the unmet medical need for the triple-exposed population [13][14] Upcoming Data and Events - The upcoming ASH conference is expected to provide critical data on dose expansion and efficacy, particularly regarding duration of response and justification for the 600 mg dose [31][32] - The company aims to present data that will inform the design of the phase III trial and its relevance to the future CLL marketplace [29][32] Competitive Landscape - Bexdeg is positioned as a highly selective drug compared to competitors, with proteomics data indicating minimal off-target effects [36][38] - The company is also exploring applications in inflammation and immunology, with ongoing studies for IRAK4 and STAT6 degraders [41][52] Financial Position - Nurix has over $650 million in cash, providing a runway through the end of 2027 into 2028, which supports the launch of pivotal programs and advancement of the pipeline [55][56] Conclusion - Nurix Therapeutics is at the forefront of targeted protein degradation, with promising clinical data and a strong financial position to support its innovative therapies in oncology and inflammation. The upcoming ASH conference will be pivotal for investor insights and future developments.