EAACI: Dupixent demonstrated superiority over Xolair (omalizumab) in chronic rhinosinusitis with nasal polyps in patients with coexisting asthma in first-ever presented phase 4 head-to-head respiratory study New late-breaking data at EAACI showed Dupixent outperformed Xolair across all primary and secondary efficacy endpoints of CRSwNP and in all asthma-related endpoints Dupixent also outperformed Xolair in improving such key signs and symptoms as nasal polyp size and sense of smell in CRSwNP, and lung func ...

文章核心观点 Regeneron和赛诺菲公布EVEREST 4期试验积极结果，在治疗重度慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）和哮喘患者中，Dupixent在所有CRSwNP主要和次要疗效终点以及所有哮喘相关终点上均优于Xolair，强化了其治疗上下呼吸道疾病的疗效 [1]。 试验结果 CRSwNP和哮喘治疗效果 - Dupixent在CRSwNP所有主要和次要疗效终点及所有哮喘相关终点上均优于Xolair，治疗4周就可见差异 [1][3] - 24周时，Dupixent较Xolair在鼻息肉大小主要终点上降低1.60分（p<0.0001），嗅觉识别能力主要终点上提高8.0分（p<0.0001），更多患者嗅觉改善超阈值；在鼻充血/阻塞关键次要终点上降低0.58分（p<0.0001），嗅觉丧失关键次要终点上改善0.81分（p<0.0001），症状严重程度降低1.74分（p<0.0001）；健康相关生活质量差异12.7分（p<0.0001），峰值鼻吸气流量差异31.27分（p<0.0001），鼻-鼻窦炎总体严重程度差异1.87分（p<0.0001）；肺功能差异150 mL（p=0.003），哮喘控制差异0.48分（p<0.0001） [4] 安全性结果 - 试验安全性结果与Dupixent获批呼吸道适应症已知安全性一致，Dupixent和Xolair不良事件总体发生率分别为64%和67%，严重不良事件报告率分别为2%和4%，导致试验中止的不良事件报告率分别为3%和1% [3] 试验相关信息 试验设计 - EVEREST是随机双盲4期试验，比较Dupixent与Xolair对重度、未控制CRSwNP和轻、中、重度哮喘成人患者的疗效和安全性 [5] - 360名患者随机分组，分别每两周接受300 mg Dupixent（n=181）或根据体重和免疫球蛋白E（IgE）水平每两周或四周接受Xolair（n=179），均加用糠酸莫米松鼻喷雾剂（MFNS） [2] 评估终点 - 主要终点评估鼻息肉评分（NPS）和宾夕法尼亚大学嗅觉识别测试（UPSIT）自基线的变化；次要终点包括鼻充血（NC）、嗅觉丧失（LoS）、总症状评分（TSS）等自基线的变化；其他终点评估支气管扩张剂使用前1秒用力呼气量（pre-BD FEV1）和7项哮喘控制问卷（ACQ - 7） [6] 药物相关信息 Dupixent介绍 - 由再生元专有VelocImmune技术发明，是完全人源单克隆抗体，抑制白细胞介素 - 4（IL - 4）和白细胞介素 - 13（IL - 13）通路信号传导，非免疫抑制剂 [7] - 开发项目在3期试验中显示显著临床益处和2型炎症减少，表明IL - 4和IL - 13是2型炎症关键驱动因素 [7] - 已在60多个国家获得一种或多种适应症监管批准，全球超100万患者正在接受治疗 [8] 研发进展 - Regeneron和赛诺菲正在3期试验中研究Dupixent在多种由2型炎症或其他过敏过程驱动的疾病中的应用，包括不明原因慢性瘙痒、大疱性类天疱疮和慢性单纯性苔藓，但安全性和有效性尚未得到监管机构全面评估 [10] 美国适应症 - 用于治疗中重度湿疹、中重度嗜酸性或口服类固醇依赖性哮喘、CRSwNP、嗜酸性食管炎、结节性痒疹、慢性阻塞性肺疾病、慢性自发性荨麻疹等不同年龄段患者 [11][18] 公司介绍 再生元 - 领先生物技术公司，由医生科学家创立和领导，发明、开发和商业化改变生命的药物，药物和管线旨在帮助多种疾病患者 [23][24] - 利用专有技术推动科学发现和药物开发，如VelociSuite技术可生产优化的完全人源抗体和新型双特异性抗体 [25] 赛诺菲 - 以研发为驱动、人工智能赋能的生物制药公司，致力于改善人们生活和实现强劲增长，应用对免疫系统的深入理解发明药物和疫苗 [27] - 在泛欧证券交易所和纳斯达克上市 [28]

Regeneron Pharmaceuticals (REGN) FY 2025 Annual General Meeting June 13, 2025 10:30 AM ET Speaker0 Good morning, and welcome to the twenty twenty five Annual Shareholder Meeting of Regeneron Pharmaceuticals. The meeting will begin after the following message. Speaker1 At Regeneron, we've always pursued bold science to drive our purpose, transforming lives through groundbreaking innovation. That principle is just as strong today as it was when the company was founded. Speaker2 We committed to not just treati ...

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) 46th Annual Goldman Sachs Global Healthcare Conference June 9, 2025 10:40 AM ET Company Participants Christopher R. Fenimore - Executive VP of Finance & CFO Ryan Crowe - Senior Vice President of Investor Relations & Strategic Analysis Conference Call Participants Salveen Jaswal Richter - Goldman Sachs Group, Inc., Research Division Salveen Jaswal Richter Great. Good morning, everyone. Thank you for joining us. I'm Salveen Richter, biotechnology analyst at Goldma ...

Regeneron Pharmaceuticals (REGN) FY Conference June 09, 2025 10:40 AM ET Speaker0 Morning, everyone. Thank you for joining us. I'm Salveen Richter, biotechnology analyst at Goldman Sachs. I'm really pleased to be joined by the Regeneron team. Next to me is Chris Feinmore, Head of Finance and CFO and Ryan Crow, Head of IR and Strategic Analysis. So to start here, actually, Ryan, let me turn it over to you because I think you have some opening comments. Speaker1 Yeah, just some forward looking statement busin ...

Atopic dermatitis is a chronic disease that disproportionately impacts communities of color Dupixent achieved 75% or greater improvement in overall disease severity, the primary endpoint, in more than three-quarters of treated patients Patients experienced substantial reductions in hyperpigmentation, dry skin and itch from baseline Results support commitment to enhance clinical understanding of chronic diseases in communities of color TARRYTOWN, N.Y. and PARIS, June 07, 2025 (GLOBE NEWSWIRE) -- Regeneron Ph ...

Regeneron Pharmaceuticals (REGN) has been in a persistent downtrend for over 280 days. The stock is currently in the 10th Phase of its 18-Phase Adhishthana Cycle, our proprietary cyclical framework. Let's break down why this fall isn't just technical noise and what the Adhishthana Principles reveal about what lies ahead.A Look Back at Regeneron's Adhishthana Cycle so farRegeneron's current cycle began on January 29, 2018, and for much of it, the stock moved in line with Adhishthana’s expectations. The early ...

CHONGQING, CHINA - OCTOBER 31: The Regeneron webpage is displayed on a smartphone in front of the ... More Regeneron Pharmaceuticals, Inc. logo on October 31, 2024 in Chongqing, China. (Photo by Cheng Xin/Getty Images)Getty Images Regeneron Pharmaceuticals (NASDAQ:REGN) shares witnessed a notable 19% decline on Friday, May 30, in the wake of the unexpected failure of itepekimab, its chronic obstructive pulmonary disease (COPD) treatment in conjunction with Sanofi, during a late-stage clinical trial. One of ...

New licensing agreement with Hansoh Pharma provides Regeneron with HS-20094, a GLP-1/GIP receptor agonist in advanced stages of clinical development in China Phase 2 data suggest potentially similar profile to the only FDA-approved GLP-1/GIP receptor agonist Key complementary asset enables synergy and flexibility across Regeneron’s broad pipeline of obesity and metabolic programs focused on improved quality of weight loss, co-morbidities and long-term health TARRYTOWN, N.Y., June 02, 2025 (GLOBE NEWSWIRE) ...

Trial demonstrated that approximately 35% of semaglutide-induced weight loss was due to loss of lean mass Combining semaglutide with muscle-preserving antibodies protected lean mass – sparing approximately 50%-80% of the lean mass lost with semaglutide alone – while also increasing loss of fat mass TARRYTOWN, N.Y., June 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced interim results from the ongoing Phase 2 COURAGE trial investigating novel combinations of semaglu ...