Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP Current treatment options leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps Dupixent is the leading biologic medicine for all five FDA-approved indications in new-to-brand prescriptions TARRYTOWN, N.Y. and PARIS, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food an ...

  Dupixent is the first and only biologic to achieve significant improvements in disease remission and symptoms in bullous pemphigoid positive pivotal study Study met the primary and all key secondary endpoints in adults with moderate-to-severe disease; five times more patients achieved sustained disease remission with Dupixent than placeboDupixent is the first medicine to show significant steroid-sparing effect in this debilitating and life-threatening disease If approved, Dupixent would be the first and o ...

Late-breaking data at WCLC show Libtayo monotherapy nearly doubled median overall survival and reduced the risks of death and disease progression by 41% and 50%, respectively, compared to chemotherapy WCLC presentation also reviews data on overall survival, progression-free survival and response rate among patients who added chemotherapy to Libtayo following disease progression TARRYTOWN, N.Y., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced five-year resul ...

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Wells Fargo 2024 Healthcare Conference September 5, 2024 12:45 PM ET Company Participants Marion McCourt - EVP, Commercial Ryan Crowe - SVP, IR and Strategic Analysis Conference Call Participants Mohit Bansal - Wells Fargo Mohit Bansal Great. So my name is Mohit Bansal, and thank you for the post lunch session. So we will try to keep it exciting, just for the post lunch session. But thank you very much team Regeneron for joining us today. So we have Marion McCou ...

会议主要讨论的核心内容 - 公司正在推出高剂量EYLEA,并取得良好的市场份额增长,已经占到抗VEGF类药物市场的45%[4][5][6] - EYLEA HD的临床和安全性结果与原EYLEA一致,但能够提供更长的给药间隔,满足患者需求[5][6][16][17] - 公司正在积极推动EYLEA HD的市场渗透,并计划于2025年推出预充式注射器[19][22] - DUPIXENT在特应性皮炎治疗中已经成为标准疗法,未来仍有较大的市场扩展空间[24][25][26] - 公司正在积极推进DUPIXENT在COPD适应症的上市,预计将于今年9月获批[33][34][35][37] - 公司的其他管线如LAG-3抑制剂、IL-33抑制剂、肌肉生长抑制剂等也有重要进展,未来有望带来新的增长动力[43][46][47][52][53][54] 问答环节重要的提问和回答 - 分析师询问EYLEA HD的市场份额变化情况,公司表示正在稳步推进EYLEA HD成为新的标准疗法,并正在获得从其他产品的转换患者[7][8] - 分析师询问DUPIXENT在特应性皮炎治疗中是否会面临新竞争产品的挑战,公司表示DUPIXENT已经建立了"第一且最佳"的地位,具有独特的双重作用机制优势[27][28][29] - 分析师询问公司在COPD适应症的商业化准备情况,公司表示将利用DUPIXENT在哮喘治疗中的经验,同时加强对该人群的教育和支付准入工作[34][35][36][37] - 分析师询问公司在肌肉生长抑制剂和食物过敏治疗方面的管线进展,公司表示未来一年内将有重要的临床数据读出[51][52][53][54]

These stocks have generally delivered competitive returns.Is Cathie Wood a genius investor? The CEO of Ark Invest, an investment management firm, rose in prominence in the early days of the pandemic; her firm's actively managed ETFs performed well even as the rest of the market was moving in the wrong direction.While her performance has been more mixed since, there is no question that some of Wood's picks look like long-term winners. Let's consider two of the bunch that could deliver outsized returns throug ...

会议主要讨论的核心内容 - 公司CFO Chris Fenimore上任一年来的三大优先事项包括加强与投资者沟通、执行资本配置策略、审慎管理商业和研发投资 [6][7][8] - 公司目前不提供年度收入指引,主要依赖外部数据源,但会在必要时主动披露一些信息以提高透明度 [10][11] - 公司正在评估是否在未来某个时间点启动股息支付,但目前还未确定具体时间和支付比例 [13] - 公司保持积极的业务开发活动,关注一些能与现有技术协同的机会,未来可能会更多考虑并购 [15][16] 问答环节重要的提问和回答 - 高剂量EYLEA在美国的转换情况良好,公司有信心未来成为该治疗领域的最大参与者 [20][21][23] - 公司正在开发EYLEA高剂量的预充式注射器,预计2025年初上市,这将进一步提升产品竞争力 [27][28] - DUPIXENT在适应症外的销售占比已达三分之一,公司看好其在其他适应症如COPD的增长潜力 [41][42][51] - 公司正在积极准备DUPIXENT在COPD适应症的上市,预计在获批后的几个月内完成与支付方的谈判 [50][51][53] - 公司正在通过多项专利保护DUPIXENT在美国的市场独占地位,预计最早2031年面临潜在竞争 [61][62] - 公司正在开展LAG-3抑制剂与LIBTAYO联合治疗肺癌的关键性试验,预计年内获得初步结果 [64][65][67]

Regeneron Pharmaceuticals, Inc. (REGN) announced that the European Commission (EC) approved odronextamab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.The drug has been approved under the brand name Ordspono.The approval is based on results from the phase I ELM-1 and pivotal phase II ELM-2 trials, which demonstrated robust, durable response rates in adults with R/R FL or R/R DLB ...

Regeneron Pharmaceuticals, Inc. (REGN) announced that it has received a complete response letter (CRL) from the FDA for its biologics license application (BLA) for pipeline candidate linvoseltamab.The BLA is seeking FDA approval of linvoseltamab for the treatment of relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies.Regeneron stated that the sole issue identified in the CRL is related to findings from a pre-approval inspection at a third-party fill/finis ...

文章核心观点 - 美国FDA对公司的生物制品许可申请(BLA)发出了完全回应信(CRL),主要原因是第三方填充/完成制造商在另一家公司的产品候选药物中发现了问题[1][2][3] - 公司正在与第三方制造商和FDA密切合作,希望尽快解决问题,将该药物带给需要的多发性骨髓瘤患者[3] - 该药物在欧洲仍在监管审查中[4] 公司概况 - 公司是一家领先的生物技术公司,专注于研发和商业化治疗严重疾病的创新药物[5] - 公司拥有自主研发的多项技术平台,如VelociSuite®,可生产优化的全人源抗体和新型双特异性抗体[6] - 公司还利用Regeneron Genetics Center®的数据洞见和基因医学平台,发现创新靶点和潜在治疗方法[6] 产品管线 - 该公司正在研发多种针对不同适应症的产品候选药物,包括眼科、过敏和炎症、肿瘤、心血管和代谢、神经系统、血液、传染病和罕见病等[5] - 其中一款候选药物linvoseltamab正在针对复发/难治性多发性骨髓瘤进行监管审查[1][4]