Update on FDA priority review of Dupixent for the treatment of COPD patients with type 2 inflammation Paris and Tarrytown, NY May 31, 2024. The US Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The revised target action date is September 27, ...

You could buy these in any month, really. The stock market has performed relatively well since the beginning of the year although, of course, there is no guarantee that it will maintain that momentum. Who knows what curve ball the future has in store for us? Regardless of what happens, investing in market leaders with robust underlying businesses and excellent prospects is still usually a good idea. Let's consider two such stocks in the biotech industry: Vertex Pharmaceuticals (VRTX 1.36%) and Regeneron Pha ...

Regeneron Pharmaceuticals, Inc. (REGN) announced positive new results from an ongoing phase I/II study on pipeline candidate REGN7075. The phase I/II first-in-human, open-label study is evaluating REGN7075, in combination with oncology drug Libtayo (cemiplimab). The study is currently enrolling patients with metastatic and locally advanced solid tumors who have exhausted standard treatment options. The trial includes an ongoing phase I dose-escalation portion and a phase II dose-expansion period. Patients f ...

文章核心观点 - 公司正在进行一项1/2期临床试验 评估其首创性双特异性抗体REGN7075与Libtayo联合用药在晚期实体瘤患者中的疗效 [1][2][8] - 该联合用药在微卫星稳定性结直肠癌(MSS CRC)患者中显示出抗肿瘤活性 这是首个在MSS CRC中展现临床活性的免疫治疗方案之一 [2][3] - 该联合用药安全性可控 未达到最大耐受剂量 大部分不良反应为1-2级 [4][5] - 公司正在开发一系列创新型肿瘤免疫治疗药物 包括检查点抑制剂、CD3双特异性抗体和CD28共刺激双特异性抗体 [6][10] 根据目录分别总结 临床试验结果 - 在94例接受联合用药的患者中 65%为MSS CRC患者 其中51例MSS CRC患者接受了有效剂量 [2] - 在这51例MSS CRC患者中 总反应率为6% 疾病控制率为29% 包括1例完全缓解、2例部分缓解和12例稳定病情 所有反应者均无肝转移 [2][3] - 在15例无肝转移患者中 总反应率为20% 疾病控制率为80% [3] - 在36例有肝转移患者中 3例出现稳定病情 1例在数据截止后出现部分缓解 [4] 安全性 - 联合用药总体安全性可控 未达到最大耐受剂量 [4][5] - 98%患者出现任何级别不良事件 35%出现3-4级不良事件 90%出现治疗相关不良事件 其中7%为3-4级 [5] - 大部分治疗相关不良事件为1-2级 最常见为输注反应(58%) 可通过预处理和剂量调整管理 [5] - 5%患者因不良事件停药 3例因2级输注反应停药 未观察到细胞因子释放综合征和治疗相关死亡 [5] 公司在肿瘤领域的发展 - 公司正在开发一系列创新型肿瘤免疫治疗药物 包括检查点抑制剂、CD3双特异性抗体和CD28共刺激双特异性抗体 [6][10] - 公司自主研发的Libtayo是多种联合疗法的基础 [10] - 公司正在广泛的实体瘤和血液肿瘤领域开展临床试验 [7][14] - 公司拥有丰富的生物技术平台和管线 致力于为患者提供创新疗法 [9][25][26]

NEW YORK, May 22, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company") (NASDAQ: REGN). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980. The investigation concerns whether Regeneron and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On Apr ...

Dupixent® late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM NOTUS results confirm landmark data from the phase 3 BOREAS study and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation Data support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted therap ...

NOTUS results confirm landmark data from the Phase 3 BOREAS trial and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation Data support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted therapy for COPD TARRYTOWN, N.Y. and PARIS, May 20, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: ...

TARRYTOWN, N.Y. and WASHINGTON, D.C., May 17, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Society for Science (the Society) announced that Grace Sun, 16, of Lexington, Kentucky, won the $75,000 top award, the George D. Yancopoulos Innovator Award, named in honor of the pioneering drug researcher and Regeneron co-Founder, Board co-Chair, President and Chief Scientific Officer, in the 2024 Regeneron International Science and Engineering Fair (Regeneron ISEF), the world's largest ...

TARRYTOWN, N.Y. and WASHINGTON, D.C., May 17, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Society for Science (the Society) announced that Grace Sun, 16, of Lexington, Kentucky, won the $75,000 top award, the George D. Yancopoulos Innovator Award, named in honor of the pioneering drug researcher and Regeneron co-Founder, Board co-Chair, President and Chief Scientific Officer, in the 2024 Regeneron International Science and Engineering Fair (Regeneron ISEF), the world's largest ...

业绩总结 - EYLEA和EYLEA HD在第一季度的市场份额达到45%[8] - EYLEA HD在第一季度的销售额较上一季度增长了63%，达到2亿美元[8] - Sanofi预计DUPIXENT全球销售额将达到140亿美元[20] 未来展望 - 预计到2026年底，公司将支付余额，取决于DUPIXENT的表现和利润率的发展[51] - 预计在发展余额支付后，合作利润或我们的利润份额将增加约6亿至8亿美元[51] 新产品和新技术研发 - 公司对肥胖平台的Activin和myostatin抗体充满信心，计划在明年下半年公布结果[41] - linvoseltamab的PDUFA日期即将到来，预计在8月份[57] 市场扩张和并购 - 公司拥有约12亿美元的现金余额，并宣布了30亿美元的额外授权，以继续向股东返还资本[72] 负面信息 - FDA要求DUPIXENT在COPD治疗中提供额外数据，公司已提交回应[28]