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Linvoseltamab in Combination with Carfilzomib or Bortezomib Shows Promising Initial Results in Earlier Lines of Treatment for Relapsed/Refractory Multiple Myeloma
Globenewswire· 2025-05-22 21:00
Core Insights - Regeneron Pharmaceuticals announced initial results from the Phase 1b LINKER-MM2 trial evaluating linvoseltamab in combination with proteasome inhibitors for relapsed/refractory multiple myeloma, showing high response rates [1][2] Summary by Sections Trial Overview - The LINKER-MM2 trial is a Phase 1b, open-label study assessing linvoseltamab combined with carfilzomib or bortezomib in patients with relapsed/refractory multiple myeloma who have progressed after at least two lines of therapy [9][11] Efficacy Results - In the carfilzomib cohort, 90% objective response rate (ORR) was observed with 76% achieving complete response (CR) after a median follow-up of 15 months [3] - In the bortezomib cohort, an 85% ORR was reported with 50% achieving CR after a median follow-up of 9 months [4] Safety Profile - Common treatment-emergent adverse events (TEAEs) in the carfilzomib cohort included neutropenia (65%), cytokine release syndrome (CRS; 61%), and infections (91%) [3] - In the bortezomib cohort, the most common TEAEs were CRS (58%), neutropenia (54%), and infections (75%) [5] Future Directions - A registrational, randomized Phase 3 trial is planned to investigate the combination of linvoseltamab and carfilzomib against standard-of-care treatments [3] - The FDA is reviewing the Biologics License Application for linvoseltamab in the U.S., with a target action date of July 10, 2025 [7] Market Context - Multiple myeloma is the second most common blood cancer, with over 187,000 new cases diagnosed globally each year [8] - Despite treatment advances, multiple myeloma remains incurable, necessitating ongoing research and development of new therapies [8]
What Regeneron's Purchase Of 23andMe Means For Your Genetic Privacy
Forbes· 2025-05-21 20:35
Regeneron buys 23andMe Getty ImagesRegeneron Pharmaceuticals announced on Monday it will acquire bankrupt genomics firm 23andMe for $256 million through a bankruptcy auction, promising to maintain ethical standards in handling sensitive customer DNA information.According to Reuters, the New York-based pharmaceutical giant aims to leverage 23andMe’s extensive database of over 15 million customer DNA samples to enhance its genomic-driven drug discovery processes. The acquisition comes at a crucial time as con ...
海外制药企业2025Q1业绩回顾:美国药品价格改革叠加不确定的宏观环境
Guoxin Securities· 2025-05-21 05:58
证券研究报告 | 2025年05月21日 海外制药企业2025Q1业绩回顾 ——美国药品价格改革叠加不确定的宏观环境 行业研究 · 行业专题 医药生物 投资评级:优于大市(维持评级) 证券分析师:马千里 010-88005445 maqianli@guosen.com.cn S0980521070001 证券分析师:陈曦炳 0755-81982939 chenxibing@guosen.com.cn S0980521120001 证券分析师:彭思宇 0755-81982723 pengsiyu@guosen.com.cn S0980521060003 请务必阅读正文之后的免责声明及其项下所有内容 摘要 请务必阅读正文之后的免责声明及其项下所有内容 2 ◼ Pharma收入端增长整体有所放缓:2025Q1,礼来及诺和诺德在GLP-1类药物驱动下,收入端分别+45%/+18%,其中诺和诺德由于美 国compounded GLP-1药物影响,销售低于预期并下调全年收入指引;诺华、艾伯维、阿斯利康、赛诺菲分别依靠诺欣妥/可善挺、 Skyrizi/Rinvoq、Farxiga/Enhertu、Dupixent等核心品种 ...
Regeneron Pharmaceuticals, Inc. (REGN) RBC Capital Markets Global Healthcare Conference (Transcript)
Seeking Alpha· 2025-05-20 19:24
Core Insights - Regeneron Pharmaceuticals is recognized for its strong R&D capabilities and has a promising pipeline of products expected to be released in the next 6 to 12 months [1] Company Overview - The discussion features key company representatives, including George D. Yancopoulos, who serves as Board Co-Chair, President, and Chief Scientific Officer, and Mark Hudson, Senior Director of Investor Relations [1][2] - The conference is part of the RBC Capital Markets Global Healthcare Conference, indicating the company's engagement with investors and analysts [1] Upcoming Developments - A significant upcoming catalyst for Regeneron is the Phase 3 data for Itepekimab related to Chronic Obstructive Pulmonary Disease (COPD), which is anticipated to provide insights based on previous data from asthma and COPD studies [5]
Regeneron Pharmaceuticals (REGN) 2025 Conference Transcript
2025-05-20 16:02
Regeneron Pharmaceuticals (REGN) Conference Call Summary Company Overview - **Company**: Regeneron Pharmaceuticals (REGN) - **Date**: May 20, 2025 - **Key Speakers**: George Hancopoulos (Co-Chair, President, CSO), Mark Hudson (Senior Director of IR) Key Industry Insights R&D and Pipeline Developments - Regeneron is recognized for its robust R&D capabilities, with significant upcoming catalysts expected in the next six to twelve months [2][5] - The company has a strong pipeline, particularly in the areas of asthma and Chronic Obstructive Pulmonary Disease (COPD) [6][14] Clinical Trial Success - Regeneron has achieved success in eight out of eight Phase III trials for Dupixent, highlighting the effectiveness of their technology and understanding of biology [8][12] - The company emphasizes the importance of high-throughput technologies in antibody development, screening millions of antibodies to identify the best candidates [10][12] Genetic Insights and Disease Targeting - Regeneron utilizes a unique genetic database to inform its drug development, allowing for targeted approaches based on genetic variations that impact disease [12][39] - The company has identified specific genetic pathways associated with diseases like asthma and COPD, which guide their clinical focus [13][39] Product-Specific Insights Dupixent (Dupilumab) - Dupixent has shown over 30% reductions in exacerbations for eosinophilic COPD patients, setting a high bar for treatment efficacy [15][21] - For low eosinophil patients, a target of a 20% reduction in exacerbations is considered significant due to the lack of treatment options [15][16] Oncology Developments - Regeneron is excited about its oncology portfolio, particularly Libtayo (a PD-1 inhibitor) and its combination with LAG-3 fianlimab, which is expected to yield Phase III data in first-line metastatic melanoma [22][28] - The company has achieved higher complete response rates with its BCMA bispecific for myeloma compared to competitors, indicating strong potential in earlier treatment settings [21][23] Factor XI Antibodies - Regeneron is developing two antibodies targeting Factor XI, aiming to provide safer anticoagulation options with reduced bleeding risks compared to traditional therapies [31][34] - The focus is on balancing efficacy with safety to broaden the use of anticoagulants across various patient populations [36][37] Strategic Collaborations and Acquisitions - Regeneron is acquiring 23andMe to enhance its genetic research capabilities, aiming to leverage this data for broader societal health benefits [45][46] - The company believes that its investment in genetic databases differentiates it from competitors and empowers its drug development efforts [40][41] Future Outlook - Regeneron is committed to advancing its pipeline and exploring next-generation versions of existing products like Dupixent, leveraging its historical success in the industry [49][52] - The company aims to continue leading in the development of best-in-class therapies across various therapeutic areas, including oncology and genetic diseases [52][53]
REGN Signs $256M Buyout Deal With 23andMe to Boost Genomics Research
ZACKS· 2025-05-20 14:16
Core Viewpoint - Regeneron Pharmaceuticals has successfully bid for the majority of assets of 23andMe Holding Co. in a bankruptcy auction, planning to acquire key business units for $256 million [1][2]. Company Acquisition Details - Regeneron intends to acquire 23andMe's Personal Genome Service, Total Health and Research Services business units, Biobank, and related assets, while 23andMe will become a wholly-owned subsidiary of Regeneron [2]. - The acquisition does not include 23andMe's Lemonaid Health business [2]. - The deal is subject to bankruptcy court approval, regulatory clearances, and other customary closing conditions, with completion expected in Q3 2025 [3]. Strategic Benefits - The acquisition is expected to enhance Regeneron's genetics-based drug discovery efforts by integrating 23andMe's consumer genomic services with its research capabilities [6]. - Regeneron aims to leverage the acquired genetic data to drive drug discovery and development, particularly in areas such as cancer, infectious diseases, and immune disorders [4][6]. Commitment to Privacy - Regeneron has committed to maintaining 23andMe's consumer privacy standards and complying with data protection laws, ensuring transparency regarding the use of customer data [7].
Regeneron Pharmaceuticals to buy 23andMe for $256M — taking control of genetic data of millions
New York Post· 2025-05-19 16:39
Core Viewpoint - Regeneron Pharmaceuticals is acquiring 23andMe out of bankruptcy for $256 million, gaining access to a significant collection of genetic data and samples from over 15 million customers, which raises privacy concerns [1][4]. Company Acquisition Details - The acquisition includes 23andMe's Personal Genome Service, Total Health and Research Services, and its biobank [1]. - The deal is expected to close in the third quarter of 2025, pending bankruptcy court and regulatory approvals [2]. Privacy and Compliance - Regeneron has committed to adhering to 23andMe's consumer-privacy rules and will collaborate with a court-appointed ombudsman to ensure compliance [3]. - The company aims to protect the dataset with high standards of data privacy and security [3]. Background on 23andMe - 23andMe was once valued at over $6 billion after going public in 2021 but has since dropped to a valuation of approximately $50 million due to various issues, including a $30 million settlement related to a data breach affecting nearly 7 million users [4][5]. - The company filed for bankruptcy in March, prompting the California Attorney General to advise customers to delete their data from 23andMe's database [5][8]. Leadership Changes - Anne Wojcicki, co-founder and CEO of 23andMe, stepped down on the day of the bankruptcy filing following internal conflicts with the board [9]. - All seven independent board members of 23andMe resigned in September, indicating significant governance issues within the company [9].
Regeneron to buy 23andMe out of bankruptcy for $256m
Proactiveinvestors NA· 2025-05-19 13:52
Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2][3] - The company focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - Proactive's news team operates from key finance and investing hubs, including London, New York, Toronto, Vancouver, Sydney, and Perth [2][3] Group 2 - Proactive employs technology to enhance workflows and has a forward-looking approach to technology adoption [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]
Regeneron Enters into Asset Purchase Agreement to Acquire 23andMe® for $256 Million; Plans to Maintain Consumer Genetics Business and Advance Shared Goals of Improving Human Health and Wellness
Globenewswire· 2025-05-19 11:07
Core Viewpoint - Regeneron Pharmaceuticals has successfully bid for the assets of 23andMe Holding Co. for $256 million, aiming to enhance its leadership in genetics-guided research and drug development, pending bankruptcy court and regulatory approvals [1][2][3] Group 1: Acquisition Details - The planned acquisition includes 23andMe's Personal Genome Service, Total Health and Research Services, and Biobank assets, with the transaction expected to close in Q3 2025 [1] - Regeneron will operate 23andMe as a wholly owned subsidiary, continuing its consumer genomics services while excluding the Lemonaid Health business from the purchase [3][4] Group 2: Commitment to Data Privacy - Regeneron emphasizes its commitment to the privacy and ethical use of 23andMe's customer data, planning to work with an independent Customer Privacy Ombudsman to ensure compliance with privacy policies and laws [2][3] - The company has a proven track record in large-scale data management, having linked deidentified DNA sequences from nearly three million participants to electronic health records [2][3] Group 3: Strategic Vision - Regeneron aims to leverage its expertise in genetic research to support 23andMe's mission of helping individuals understand their DNA and improve personal health [2][3] - The acquisition aligns with Regeneron's broader strategy to utilize genetics research for advancing medical treatments and improving societal health outcomes [2][3][4]
75th Annual Regeneron International Science and Engineering Fair Awards Teen Scientists from Around the World More Than $9 Million in 2025 Competition
Globenewswire· 2025-05-16 15:24
Core Points - Adam Kovalčík, a 19-year-old from Slovakia, won the $100,000 George D. Yancopoulos Innovator Award for developing a cost-effective method to produce the antiviral drug galidesivir, reducing production costs from $75/gram to approximately $12.50/gram [1][3] - The Regeneron International Science and Engineering Fair (ISEF) awarded over $9 million in scholarships and prizes, showcasing nearly 1,700 young scientists from 48 U.S. states and over 60 countries [2][8] - Other notable projects included a desktop plastic recycling system, a device for detecting toxic dusts, and a brain-controlled bionic prosthetic leg, highlighting innovation in sustainability and health technology [4][5][6] Company Insights - Regeneron Pharmaceuticals, Inc. is a leading biotechnology company focused on developing life-transforming medicines for serious diseases, with a strong emphasis on scientific innovation and education [37][38] - The company has been actively involved in promoting STEM education, having provided experiences to over 3.2 million students since 2020, surpassing its goal of 2.5 million by 2025 [8] - Regeneron's commitment to corporate responsibility includes fostering a culture of integrity and excellence, as well as significant philanthropic efforts in science education [38]