Nurix Therapeutics(NRIX)
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European Medicines Agency Grants Bexobrutideg (NX-5948) Orphan Drug Designation for the Treatment of Lymphoplasmacytic Lymphoma, also Known as Waldenström Macroglobulinemia
GlobeNewswire News Room· 2025-07-07 11:00
Core Insights - Nurix Therapeutics, Inc. has received Orphan Drug Designation from the European Medicines Agency for bexobrutideg (NX-5948) aimed at treating lymphoplasmacytic lymphoma, highlighting the drug's potential in addressing significant unmet medical needs in this rare blood cancer [1][3][4] Company Overview - Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on developing targeted protein degradation medicines, which represent a new frontier in drug design for cancer and inflammatory diseases [6][7] - The company's pipeline includes degraders of Bruton's tyrosine kinase (BTK) and inhibitors of CBL-B, with ongoing collaborations with major pharmaceutical companies like Gilead Sciences, Sanofi, and Pfizer [6] Drug Development Progress - Bexobrutideg is currently undergoing a Phase 1a/b clinical trial for adults with relapsed or refractory B-cell malignancies, including Waldenström macroglobulinemia, with early safety and efficacy data showing promise for durable outcomes [5][6] - The drug has previously received Fast Track designation from the U.S. FDA for multiple indications, including treatment for Waldenström macroglobulinemia and chronic lymphocytic leukemia/small lymphocytic lymphoma [4][5] Regulatory Designation Benefits - The Orphan Drug Designation provides several incentives, including 10 years of market exclusivity in the EU upon approval, access to protocol assistance, eligibility for centralized marketing authorization, and significant reductions in regulatory fees [2]
Nurix Therapeutics, Inc. (NRIX) Expected to Beat Earnings Estimates: What to Know Ahead of Q2 Release
ZACKS· 2025-07-03 15:01
Core Viewpoint - Wall Street anticipates a year-over-year increase in earnings for Nurix Therapeutics, Inc. (NRIX) due to higher revenues, with a focus on how actual results will compare to estimates [1][3]. Earnings Expectations - The consensus estimate predicts a quarterly loss of $0.70 per share, reflecting a year-over-year change of +1.4% [3][19]. - Expected revenues are $19.81 million, which represents a significant increase of 63.9% from the same quarter last year [3][19]. Estimate Revisions - The consensus EPS estimate has remained unchanged over the last 30 days, indicating stability in analyst expectations [4][19]. - The Most Accurate Estimate is higher than the Zacks Consensus Estimate, resulting in an Earnings ESP of +4.74%, suggesting a bullish outlook from analysts [12][19]. Earnings Surprise Potential - A positive Earnings ESP reading indicates a higher likelihood of an earnings beat, especially when combined with a Zacks Rank of 2 (Buy) [10][12]. - Nurix Therapeutics has a Zacks Rank of 2, enhancing the probability of surpassing the consensus EPS estimate [12][20]. Historical Performance - In the last reported quarter, Nurix Therapeutics was expected to post a loss of $0.72 per share but actually reported a loss of -$0.67, resulting in a surprise of +6.94% [13]. - Over the past four quarters, the company has only beaten consensus EPS estimates once [14].
Wall Street Analysts Predict a 143.41% Upside in Nurix Therapeutics (NRIX): Here's What You Should Know
ZACKS· 2025-07-03 14:56
Core Viewpoint - Nurix Therapeutics, Inc. (NRIX) has seen a 2.3% increase in share price over the past four weeks, closing at $12.44, with analysts suggesting a potential upside of 143.4% based on a mean price target of $30.28 [1] Price Targets - The average of 18 short-term price targets ranges from a low of $16.00 to a high of $41.00, with a standard deviation of $6.49, indicating variability among estimates [2] - The lowest estimate suggests a 28.6% increase from the current price, while the highest estimate indicates a 229.6% upside [2] Analyst Consensus and Earnings Estimates - Analysts are optimistic about NRIX's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which historically correlates with stock price movements [4][11] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 0.7%, with two estimates moving higher and no negative revisions [12] Zacks Rank - NRIX currently holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] Price Movement Guidance - While the consensus price target may not be a reliable indicator of the extent of potential gains, it does provide a directional guide for price movement [14]
Nurix Therapeutics (NRIX) Update / Briefing Transcript
2025-06-12 13:00
Summary of Nurix Therapeutics (NRIX) Investor Call - June 12, 2025 Company Overview - **Company**: Nurix Therapeutics - **Product**: Bexabrutinib (NRX-5948) - **Focus**: Treatment of Chronic Lymphocytic Leukemia (CLL) and Waldenstrom's Macroglobulinemia Key Points Clinical Updates - **Clinical Trials**: Updates were provided on the phase one trials of Bexabrutinib, particularly focusing on patients with relapsed refractory CLL and Waldenstrom's Macroglobulinemia [2][3][4] - **Efficacy**: The overall response rate (ORR) for Bexabrutinib in relapsed refractory CLL is reported at **80.9%**, with a complete response (CR) in one patient and a partial response (PR) in **78.7%** of patients [13][20] - **Patient Demographics**: The median age of patients in the CLL study is **68.5 years**, with a heavily pretreated population having a median of **four prior lines of therapy** [9][19] - **Safety Profile**: Bexabrutinib has shown a favorable safety profile with no new safety signals reported. The most common adverse events were minor infections, which are common in CLL patients [12][27] Market Potential - **Market Size**: The BTK inhibitor market is projected to grow from **$9 billion** in 2024 to over **$15 billion** by 2028, indicating a substantial opportunity for Bexabrutinib [38] - **Patient Population**: Over **55,000 patients** start therapy for CLL each year, with significant numbers initiating therapy in various lines of treatment [39][40] Regulatory Progress - **Fast Track Designation**: Bexabrutinib received fast track designation from the FDA, supporting an accelerated pathway for registration [31] - **Future Trials**: Plans for pivotal trials in 2025 were discussed, including a single-arm phase two study for relapsed refractory CLL patients and combination trials with BCL-2 inhibitors [33][34] Competitive Landscape - **Positioning**: Bexabrutinib is positioned as a best-in-class BTK degrader, with the potential to address unmet medical needs in CLL and Waldenstrom's [30][37] - **CNS Activity**: The drug has shown promising CNS activity, which may differentiate it from competitors that exclude patients with CNS lesions [91][98] Additional Insights - **Patient Response**: The median time to response for patients is reported at **1.9 months**, with ongoing monitoring for deepening responses over time [16][20] - **Combination Therapy**: There is a focus on combination therapies as the emerging standard of care, with plans to explore this in future studies [104] Conclusion - **Future Outlook**: Nurix Therapeutics is optimistic about the potential of Bexabrutinib to shape the future standard of care in CLL and Waldenstrom's Macroglobulinemia, with ongoing clinical trials and regulatory discussions paving the way for its market entry [34][43]
Nurix Therapeutics to Host a Webcast Conference Call to Discuss Data from the Ongoing Phase 1 Clinical Trial of Bexobrutideg (NX-5948) Being Presented at the 30th European Hematology Association Congress (EHA2025)
GlobeNewswire· 2025-06-06 11:00
Core Viewpoint - Nurix Therapeutics is set to present new data from the ongoing Phase 1 clinical trial of bexobrutideg (NX-5948) at the European Hematology Association Congress, highlighting the company's focus on targeted protein degradation medicines for cancer treatment [1][5]. Company Overview - Nurix Therapeutics is a clinical-stage biopharmaceutical company specializing in the discovery, development, and commercialization of targeted protein degradation medicines aimed at improving treatment options for cancer and inflammatory diseases [5]. - The company's pipeline includes degraders of Bruton's tyrosine kinase (BTK) and inhibitors of Casitas B-lineage lymphoma proto-oncogene B (CBL-B), with a focus on innovative drug design [5]. - Nurix is advancing multiple potentially first-in-class or best-in-class degraders and degrader antibody conjugates (DACs) in its preclinical pipeline, supported by a fully AI-integrated discovery engine [5]. Clinical Trial Information - Bexobrutideg (NX-5948) is an investigational, orally bioavailable small molecule degrader of BTK, currently evaluated in a Phase 1 clinical trial for patients with relapsed or refractory B cell malignancies [4]. - The ongoing clinical trial can be accessed for additional information at clinicaltrials.gov (NCT05131022) [4]. Upcoming Presentations - The company will host a webcast conference call on June 12, 2025, to discuss the new data from the Phase 1 clinical trial, which will be presented at the EHA2025 [1][2]. - Presentations at EHA2025 include findings on the clinical activity and safety of bexobrutideg in patients with chronic lymphocytic leukemia (CLL) and Waldenström macroglobulinemia, scheduled for June 13 and June 14, respectively [6].
Nurix Therapeutics (NRIX) 2025 Conference Transcript
2025-06-04 20:47
Summary of Nurix Therapeutics (NRIX) Conference Call Company Overview - **Company**: Nurix Therapeutics (NRIX) - **Focus**: Development of degrader therapies, particularly in oncology and autoimmune diseases Key Points Product Development and Clinical Trials - **Bexdeg (NRX-5948)**: A degrader therapy currently in phase 1a trials, with updates expected by the end of the year for phase 1b data [6][10] - **Regulatory Updates**: A formal update on pivotal studies is anticipated mid-year, including feedback from the FDA regarding study design and dosing [9][10] - **Phase 2 and Phase 3 Studies**: Plans for a single-arm phase 2 study in CLL and a confirmatory randomized phase 3 study are in development, with details to be disclosed later this year [10][11] - **Waldenstrom's Group**: Approximately 80% response rate observed, similar to CLL, indicating strong activity across various indications [23][24] Strategic Focus - **Prioritization**: CLL is the primary focus, with resources allocated to maximize impact in this area [24][25] - **BTK Degrader Mechanism**: The rationale for using a BTK degrader includes addressing severe life-threatening conditions with high unmet medical needs, aiming for rapid data readouts and targeting large markets [27][30] Safety and Efficacy - **Safety Profile**: The degrader mechanism may offer a better safety profile compared to traditional inhibitors, with lower required drug levels and reduced off-target effects [34][35] - **Efficacy**: Degradation of the target protein may provide a more comprehensive therapeutic effect by eliminating both enzymatic and scaffolding functions of the protein [36] Partnerships and Collaborations - **Sanofi Partnership**: Nurix has partnered with Sanofi for the development of NX3911, a novel STAT6 degrader, with Sanofi funding IND enabling studies and phase 1 trials [46][47] - **Gilead Collaboration**: An agreement with Gilead for the Abreq4 degrader, with updates expected as they move into healthy volunteer studies [64] Pipeline Updates - **Other Pipeline Candidates**: Updates on additional candidates, including a sibyl inhibitor (1607) and another candidate (2127), are expected, with the sibyl inhibitor showing promise in a phase 1a trial across 11 solid tumors [68][69] Market Position and Future Outlook - **Market Opportunity**: The company is positioned to capitalize on a large autoimmune landscape, with potential for multiple successful products in the market [62][63] - **Competitive Edge**: Nurix aims to be best in class with its programs, leveraging its partnerships and innovative approaches to drug development [61][62] Additional Insights - **Enrollment and Data Disclosure**: Enrollment rates for ongoing studies will dictate the timing of data disclosures, particularly for the CLL cohort with warm autoimmune hemolytic anemia [38][39] - **Regulatory Strategy**: The company is focused on designing studies that are relevant to both U.S. and global populations, ensuring broad applicability of their findings [21][22]
Nurix Therapeutics (NRIX) Moves 14.2% Higher: Will This Strength Last?
ZACKS· 2025-06-03 14:10
Company Overview - Nurix Therapeutics, Inc. (NRIX) shares increased by 14.2% to close at $12.14, following a period of 5.7% loss over the past four weeks, indicating a significant rebound in stock performance [1][2] Licensing Agreement - Sanofi has exercised its option to exclusively license Nurix's STAT6 program, which includes the development candidate NX-3911, an oral and highly selective STAT6 degrader. Nurix is set to receive a license extension fee of $15 million and is eligible for up to $465 million in potential milestone payments, along with royalties on future sales [2] Financial Expectations - The company is expected to report a quarterly loss of $0.73 per share, reflecting a year-over-year change of -2.8%. Revenue is anticipated to be $17.31 million, representing a 43.2% increase from the same quarter last year [3] Earnings Estimate Revisions - The consensus EPS estimate for Nurix has been revised 1.1% higher over the last 30 days, suggesting a positive trend that may lead to price appreciation in the future [4] Industry Context - Nurix Therapeutics operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Argenx SE (ARGX), saw a 2% increase in its stock price, closing at $584.61, despite a -11.8% return over the past month [4]
Sanofi Exercises License Extension Option to Nurix’s STAT6 Program
Globenewswire· 2025-06-02 11:00
Core Insights - Nurix Therapeutics has announced that Sanofi has exercised its option to exclusively license Nurix's STAT6 program, which includes the drug candidate NX-3911, a selective STAT6 degrader [2][3] - The collaboration agreement from 2019 has resulted in a total of $127 million received by Nurix, with the potential for an additional $465 million in development, regulatory, and commercial milestones [1][3] Company Overview - Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on targeted protein degradation medicines, aiming to improve treatment options for patients with cancer and inflammatory diseases [5][6] - The company utilizes its proprietary DEL-AI drug discovery platform to identify novel agents that induce degradation of specified drug targets, with a focus on E3 ligases [3][6] Product Development - NX-3911 is a potent, orally administered STAT6 degrader that has shown robust efficacy in preclinical models for atopic dermatitis and asthma, demonstrating anti-inflammatory effects comparable to a STAT6 gene knockout [3][4] - The STAT6 program also includes additional differentiated discovery-stage assets, representing further product opportunities within the collaboration with Sanofi [3] Financial Aspects - Under the collaboration agreement, Sanofi made an upfront payment of $55 million and an additional $22 million to expand the collaboration scope, with Nurix eligible for royalties on future sales [3] - Nurix retains the option to co-develop and co-promote up to two future products in the U.S., sharing profits and losses evenly with Sanofi [3]
Sanofi Exercises License Extension Option to Nurix's STAT6 Program
GlobeNewswire News Room· 2025-06-02 11:00
Core Insights - Nurix Therapeutics has announced that Sanofi has exercised its option to exclusively license Nurix's STAT6 program, which includes the drug candidate NX-3911, a selective STAT6 degrader targeting type 2 inflammation-related diseases such as atopic dermatitis and asthma [2][3] Financial Summary - Nurix will receive a $15 million license extension fee from Sanofi, increasing the total amount received under their collaboration to $127 million [1][3] - Nurix is eligible for an additional $465 million in development, regulatory, and commercial milestones associated with the STAT6 program, along with potential future royalties [1][3] Product Development - NX-3911 is described as a potent, selective, orally administered STAT6 degrader that has shown robust efficacy in preclinical models for atopic dermatitis and asthma, demonstrating anti-inflammatory effects comparable to a STAT6 gene knockout [3][4] - The collaboration leverages Nurix's DEL-AI drug discovery platform to identify novel agents that induce degradation of specified drug targets, with Sanofi having the option to license drug candidates resulting from this work [3][4] Strategic Collaboration - This marks the second license extension of a Nurix autoimmune disease program by Sanofi within 90 days, indicating the effectiveness of Nurix's drug discovery platform [3] - Nurix retains the option to co-develop and co-promote up to two future products in the U.S., with profits and losses split evenly for those programs [3][4]
Nurix Therapeutics to Participate in the Jefferies Global Healthcare Conference
Globenewswire· 2025-05-28 11:00
Core Insights - Nurix Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on targeted protein degradation medicines aimed at improving treatment options for cancer and inflammatory diseases [3] - The company will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2025, featuring its president and CEO, Arthur T. Sands, M.D., Ph.D., and CFO, Hans van Houte [1] 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), with a focus on enhancing immune cell activation [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 Sciences, Sanofi, and Pfizer, retaining options for co-development, co-commercialization, and profit sharing in the U.S. for several drug candidates [3] - The company utilizes a fully AI-integrated discovery engine and has significant expertise in ligase, providing a competitive advantage in translating targeted protein degradation into clinical advancements [3]