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AMGEN ACQUIRES DARK BLUE THERAPEUTICS, BOLSTERING ONCOLOGY PIPELINE
Prnewswire· 2026-01-06 14:00
Acquisition Adds Differentiated Investigational Molecule Designed to Treat Acute Myeloid Leukemia Amgen expects to integrate Dark Blue Therapeutics into its existing research organization, further strengthening the company's early oncology discovery efforts. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry ...
Nurix Therapeutics to Participate in the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-05 12:00
BRISBANE, Calif., Jan. 05, 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 in oncology and autoimmune 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 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026, at 4:30 p.m. PT in San F ...
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]
Arvinas Presents Preclinical Data Supporting Mechanistic Synergies and Enhanced Antitumor Activity with the Combination of ARV-393 and Glofitamab at the 2025 American Society of Hematology Annual Meeting and Exposition
Globenewswire· 2025-12-06 13:05
Core Insights - Arvinas, Inc. announced preclinical data for ARV-393 in combination with glofitamab, showing significant tumor growth inhibition in a model of diffuse large B-cell lymphoma (DLBCL) [1][3] - The company plans to initiate a Phase 1 clinical trial for this combination approach in 2026, aiming to provide a chemotherapy-free treatment option for patients with DLBCL [2][3] Group 1: Preclinical Data and Mechanism - The combination of ARV-393 (3 mg/kg) and glofitamab (0.15 mg/kg) achieved 81% tumor growth inhibition (TGI) with concomitant dosing and 91% TGI with sequential dosing, compared to 38% for ARV-393 alone and 36% for glofitamab alone [5] - At a higher dose of ARV-393 (6 mg/kg), the combination showed increased tumor regressions, with 10 out of 10 mice responding to concomitant dosing [5] - RNA sequencing indicated that ARV-393 upregulated CD20 expression and genes promoting interferon signaling, while downregulating proliferation-associated gene sets, contributing to the observed antitumor activity [5] Group 2: Clinical Development Plans - Arvinas is currently evaluating ARV-393 in a Phase 1 clinical trial for relapsed/refractory non-Hodgkin lymphoma and plans to share clinical data from this trial at a medical congress in 2026 [3] - The addition of a glofitamab combination cohort in the ongoing Phase 1 clinical trial of ARV-393 is planned for 2026 [3] Group 3: Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing protein degradation therapies through its PROTAC platform, targeting various diseases including B-cell lymphomas [4][6] - The company is also advancing other investigational drugs targeting neurodegenerative disorders and mutated cancers [6]
Kymera Therapeutics, Inc. (KYMR) Presents at Citi Annual Global Healthcare Conference 2025 Transcript
Seeking Alpha· 2025-12-03 18:43
PresentationWe got some questions here, but maybe you want to give sort of just a real quick like kind of a couple of minute overview, and then we can get into some of the detail.All right. So welcome to the second day of the Citi Global Healthcare Conference. So I'm Geoff Meacham, I'm the senior biopharma analyst, and my team is here in front, too. So we're thrilled today to have Kymera Therapeutics. We have Bruce Jacobs, the CFO. We have Jared Gollob. So welcome, guys. Good to have you.Bruce JacobsChief F ...
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]
Kymera Therapeutics(KYMR) - 2025 FY - Earnings Call Transcript
2025-12-03 17:17
Financial Data and Key Metrics Changes - The company has a cash position of $980 million, providing a runway into the second half of 2028, which will fund both Phase II-B studies and the initiation of Phase III studies for STAT6 and IRF5 programs [29][30]. Business Line Data and Key Metrics Changes - The company is focusing on two wholly owned programs: the STAT6 program, which is nearing data readout, and the IRF5 program, set to enter the clinic next year [3][4]. - The STAT6 program has progressed through Phase I-A and is currently in Phase I-B, with plans to initiate Phase II-B studies for atopic dermatitis and asthma [10][20]. Market Data and Key Metrics Changes - The atopic dermatitis market has over 40 million diagnosed patients, but only about 1 million are treated with Dupilumab, indicating a significant unmet need that the company aims to address with its oral drug [21][22]. - The company sees a large opportunity in the pediatric population for oral medications, which are more accessible than injections [34][35]. Company Strategy and Development Direction - The company plans to focus on the two largest markets, atopic dermatitis and asthma, for its Phase II-B studies, which represent a significant portion of Dupilumab's sales [24][25]. - The company is not currently interested in partnering for the STAT6 program, believing it can execute the studies more effectively on its own [25][27]. - The company aims to introduce one new program per year, with a focus on expanding its pipeline and addressing multiple indications [69]. Management's Comments on Operating Environment and Future Outlook - Management acknowledges the competitive landscape but believes that their unique approach to targeted protein degradation positions them well for success [70][72]. - The company is committed to accelerating development timelines and minimizing idle time between clinical phases [45][49]. Other Important Information - The company is exploring the use of AI to enhance clinical operations and improve efficiency in patient recruitment and data analysis [53][54]. - The IRF5 program is positioned to target multiple autoimmune diseases, with strong preclinical data supporting its potential effectiveness [61][62]. Q&A Session Summary Question: How does the company plan to maximize the commercial opportunity for 621? - The company is focusing on the largest markets and considering potential partnerships in the future, but currently aims to maintain control over development [24][25]. Question: What is the company's strategy for accelerating development? - The company plans to conduct two Phase II-B studies that will inform multiple Phase III studies across various indications [45][46]. Question: How does the company view the competitive landscape in targeted protein degradation? - The company believes its focused approach and deep expertise give it a competitive advantage over larger firms with less targeted efforts [70][72].
Kymera Therapeutics(KYMR) - 2025 FY - Earnings Call Transcript
2025-12-03 17:17
Financial Data and Key Metrics Changes - The company has a cash position of $980 million, providing a runway into the second half of 2028, which will fund both phase 2B studies and the initiation of at least the first phase 3 study for STAT6 [29][30]. Business Line Data and Key Metrics Changes - The company is focusing on two wholly owned programs: the STAT6 program, which is nearing data readout, and the IRF5 program, set to enter the clinic next year [3][4]. - The STAT6 program has progressed through phase 1A and is currently in phase 1B, with objectives to confirm dosing for phase 2B based on prior data [6][8]. Market Data and Key Metrics Changes - The atopic dermatitis (AD) market has over 40 million diagnosed patients, but only about 1 million are treated with Dupixent (Dupy), indicating a significant unmet need for effective treatments [21][22]. - The company aims to target a broader patient population with its oral drug, which could potentially reach a larger market compared to injectable biologics like Dupy [22][35]. Company Strategy and Development Direction - The company plans to focus on AD and asthma for its phase 2B studies, which represent a significant portion of Dupy's revenue [24][25]. - The strategy includes maintaining control over development to accelerate timelines and potentially expand into multiple indications based on initial phase 2B data [45][46]. - The company is not currently interested in partnering for the STAT6 program, believing it can execute the studies more effectively on its own [25][27]. Management's Comments on Operating Environment and Future Outlook - Management acknowledges the competitive landscape in the immunology space but believes their unique oral drug could provide a compelling alternative to existing biologics [3][22]. - The company is optimistic about the potential of its IRF5 program, which targets multiple pathways relevant to autoimmune diseases, and plans to move into phase 1 early next year [60][61]. Other Important Information - The company is exploring the use of AI to enhance clinical operations and improve efficiency in patient recruitment and data analysis [53][54]. - The IRF5 program has shown promising preclinical data, indicating potential for transformative treatment in diseases like lupus and rheumatoid arthritis [60][66]. Q&A Session Summary Question: How does the company plan to maximize the commercial opportunity for 621? - The company is focusing on the largest markets for phase 2B studies and is considering a range of potential indications based on the success of the drug [23][24]. Question: What is the company's strategy regarding partnerships for the STAT6 program? - The company has decided against partnerships for the STAT6 program, believing it can manage the development effectively on its own [25][27]. Question: How does the company view the competitive landscape for targeted protein degradation? - The company believes its focused approach and expertise in the field give it a competitive advantage over larger firms with less specialization [70][71].
Monte Rosa Therapeutic (NasdaqGS:GLUE) FY Conference Transcript
2025-12-02 19:32
Monte Rosa Therapeutic (NasdaqGS:GLUE) FY Conference December 02, 2025 01:30 PM ET Company ParticipantsMarkus Warmuth - CEOConference Call ParticipantsTed Tenthoff - Senior Biotech AnalystTed TenthoffGreat. Good afternoon, everyone. My name is Ted Tenthoff. I'm a senior biotech analyst at Piper Sandler. And before I begin, I'm required to point out certain disclosures regarding the relationship between our next presenting company, Monte Rosa, and Piper, which are listed at the back of the room and also at t ...
Arvinas to Present at Piper Sandler 37th Annual Healthcare Conference
Globenewswire· 2025-11-26 12:00
Core Insights - Arvinas, Inc. is a clinical-stage biotechnology company focused on developing targeted protein degradation therapies to treat debilitating and life-threatening diseases [3] Company Overview - Arvinas utilizes its PROTAC (PROteolysis TArgeting Chimera) platform to create therapies that leverage the body's natural protein disposal system for the selective degradation of disease-causing proteins [3] - The company is advancing multiple investigational drugs through clinical development, including ARV-102 for neurodegenerative disorders, ARV-393 for relapsed/refractory non-Hodgkin Lymphoma, ARV-806 for KRAS G12D mutated cancers, and vepdegestrant for ER+/HER2- breast cancer [3] Upcoming Events - Noah Berkowitz, M.D., Ph.D., Chief Medical Officer, and Andrew Saik, Chief Financial Officer, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 4 at 11:00 a.m. ET in New York [1] - A live audio webcast of the presentation will be available on the company's website [2]