Key Takeaways CHMP recommends EU approval of Dupixent for chronic spontaneous urticaria in patients 12 and above.Phase III studies showed Dupixent reduced itch, hives and improved disease control.Dupixent sales hit EUR 7.3B in H1 2025, with Sanofi projecting about EUR 22B in sales by 2030.Sanofi (SNY) and partner Regeneron (REGN) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of Dupixent (dupilumab) in ...

The most talked about and market moving research calls around Wall Street are now in one place. Here are today's research calls that investors need to know, as compiled by The Fly.Top 5 Upgrades: TD Cowen upgraded Paycom (PAYC) to Buy from Hold with a price target of $258, up from $246. The firm cites positive indications from its 2025 human capital management survey and the company's commentary at a recent conference on its near-term capex expectations for the upgrade. Morgan Stanley upgraded Applied ...

监管进展 - 欧洲药品管理局人用药品委员会采纳积极意见 推荐批准Dupixent用于治疗慢性自发性荨麻疹 覆盖12岁及以上中重度患者群体[1] - 最终批准决定预计在未来几个月内做出[1] - 若获批 Dupixent将成为欧盟十余年来首个针对慢性自发性荨麻疹的靶向药物[10] 临床试验数据 - 支持意见的数据来自LIBERTY-CUPID三期项目中的两项研究(NCT04180488 A研究和C研究)[2] - 研究显示Dupixent在24周时相比安慰剂显著减少瘙痒和荨麻疹症状[2][10] - 项目中的B研究在不同患者群体中提供了额外安全性数据[2] - 安全性结果与已知安全性特征基本一致 成人及青少年患者中发生率≥5%的不良事件包括注射部位反应、COVID-19感染、高血压、慢性自发性荨麻疹和意外过量[3] 产品特性与适应症 - Dupixent是全人源单克隆抗体 通过抑制白细胞介素4和白细胞介素13信号通路发挥作用 非免疫抑制剂[6] - 目前已在包括日本和美国在内的多个国家获批用于特定成人和青少年慢性自发性荨麻疹患者[4] - 全球超过60个国家批准用于一种或多种适应症 包括特应性皮炎、哮喘、慢性鼻窦炎伴鼻息肉、嗜酸性食管炎、结节性痒疹、慢性自发性荨麻疹、慢性阻塞性肺病和大疱性类天疱疮[7] - 全球正在接受治疗的患者超过100万人[7] 疾病背景 - 慢性自发性荨麻疹是慢性炎症性皮肤疾病 部分由2型炎症驱动 导致突发性虚弱性荨麻疹和反复发作的瘙痒[5] - 标准治疗为靶向H1受体的抗组胺药 但许多患者症状仍无法控制[5] 研发合作与管线 - Dupilumab由赛诺菲和再生元根据全球合作协议共同开发[8] - 迄今已在60多项临床研究中涉及超过10,000名患有2型炎症相关慢性疾病的患者[8] - 除已批准适应症外 正在进行三期研究的疾病包括未知原因慢性瘙痒和慢性单纯性苔藓[9] 公司背景 - 再生元(NASDAQ: REGN)是领先的生物技术公司 专注于为严重疾病患者开发变革性药物[11] - 利用VelociSuite等专有技术生产优化全人源抗体和新型双特异性抗体[12] - 赛诺菲(EURONEXT: SAN, NASDAQ: SNY)是研发驱动型生物制药公司 专注于免疫系统相关药物和疫苗开发[14][15]

Sanofi and Regeneron’s Dupixent to treat chronic spontaneous urticaria advances in EU with positive CHMP opinion Recommendation for adults and adolescents based on phase 3 studies showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo If approved, Dupixent would be the first targeted medicine in over a decade indicated for CSU in the EU Paris and Tarrytown, September 22, 2025. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a p ...

Recommendation for adults and adolescents based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo If approved, Dupixent would be the first targeted medicine in over a decade indicated for CSU in the European Union (EU) TARRYTOWN, N.Y. and PARIS, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted ...

Regeneron said on Friday its experimental therapy showed either a complete or partial disappearance of a precancerous disorder, which manifests into blood cancer, in all patients in a mid-stage trial. ...

Inmazeb® (atoltivimab, maftivimab, and odesivimab-ebgn) was the first treatment approved by the U.S. Food and Drug Administration (FDA) for Orthoebolavirus zairense, also known as Zaire ebolavirus Supply is being rushed to Democratic Republic of Congo (DRC) to help with the current outbreak TARRYTOWN, N.Y., Sept. 19, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will donate up to 500 doses of Inmazeb® (atoltivimab, maftivimab, and odesivimab-ebgn), an Ebola ...

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is one of best affordable biotech stocks to invest in now. Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) announced on September 8 the results evaluating “its first-in-class investigational allergen-blocking antibodies in allergen-challenge Phase 3 trials in adults with moderate-to-severe cat or birch allergies.” Why Regeneron Pharmaceuticals, Inc. (REGN) Crashed Last Week The results showed that both trials met their respective primary and key secondary endpo ...

核心观点 - 司美格鲁肽与trevogrumab联合治疗在26周临床试验中显著减少瘦体重流失 同时增强脂肪减少效果 其中trevogrumab可预防约50%由司美格鲁肽引发的瘦体重损失[1][2] - 所有治疗组均观察到代谢和血脂参数的数值改善 包括腰围 血压 胆固醇 甘油三酯和糖化血红蛋白[1][5] - 三联疗法（司美格鲁肽+高剂量trevogrumab+garetosmab）实现最显著的脂肪减少（-27.1%）和总体重减轻（-13.4%）但安全性问题导致停药率较高[3][7] 临床试验设计 - COURAGE试验针对肥胖患者（BMI≥30 kg/m²）设计 包含26周减重阶段和26周体重维持阶段[2] - 患者随机分配至四组：司美格鲁肽2.4mg单药治疗 司美格鲁肽+200mg trevogrumab（低剂量组合） 司美格鲁肽+400mg trevogrumab（高剂量组合） 司美格鲁肽+400mg trevogrumab+10mg/kg garetosmab（三联疗法）[2] - 主要疗效终点包括第26周时瘦体重 脂肪量和体重的基线变化百分比[2] 疗效数据 - 司美格鲁肽单药治疗导致33%的体重减轻来自瘦体重损失（-3.3kg）而联合治疗显著降低该比例：低剂量组合瘦体重损失占比16.8%（-1.5kg） 高剂量组合18.1%（-1.9kg） 三联疗法仅7.4%（-0.9kg）[3] - 脂肪减少效果显著提升：单药治疗脂肪减少-15.7%（-6.7kg） 低剂量组合-17.3%（-7.6kg） 高剂量组合-19.1%（-8.5kg） 三联疗法-27.1%（-11.8kg）[3] - 总体重减轻幅度：单药治疗-10.6% 低剂量组合-9.9% 高剂量组合-11.1% 三联疗法-13.4%[3] 安全性与耐受性 - 司美格鲁肽与trevogrumab联合治疗总体耐受性良好 常见不良事件（≥5%发生率）包括肌肉痉挛 恶心 便秘 疲劳 腹泻 头痛等 多数为轻度至中度[6] - 三联疗法因耐受性问题导致停药率显著较高 并报告两例死亡事件 一例为多重心血管风险患者死因未明 一例为有心血管病史患者心脏骤停 未确认与治疗存在因果关系[7] 公司战略与背景 - 公司专注于肥胖治疗领域 针对GLP-1受体激动剂导致的肌肉流失问题开发保护瘦体重的组合疗法[9][10] - 采用VelocImmune技术平台开发全人源抗体 该技术曾用于创建多款FDA批准抗体药物包括Dupixent、Libtayo等[11] - 公司管线包含针对肥胖相关代谢疾病的多种候选药物 具备与GLP-1受体激动剂联合开发的潜力[10][13]

Regeneron Pharmaceuticals said on Wednesday its experimental treatment for a rare genetic disorder that affects bone tissue has met the main goal of a late-stage trial. ...