Chautauqua Capital Management, a division of Baird Asset Management, is a boutique investment firm that released its second quarter 2025 investor letter for the "Baird Chautauqua International and Global Growth Fund". A copy of the letter can be downloaded here. Global equity markets experienced a significant shift during the quarter, moving from notable losses to reaching new highs. Markets fell following the President's announcement of unexpectedly severe tariffs, which raised recession fears. After a bri ...

Key Takeaways Regeneron gained FDA approval to expand Evkeeza use to children aged 1 to under 5 with HoFH.The label extension was supported by efficacy and safety data from six young HoFH patients.Evkeeza posted $72.1M in U.S. sales in H1 2025, with Ultragenyx handling ex-U.S. commercialization.Regeneron Pharmaceuticals, Inc. (REGN) announced that the FDA has approved a label extension of its cholesterol drug Evkeeza (evinacumab-dgnb).Evkeeza ANGPTL3 antibody has been approved as an adjunct to diet and exer ...

About two and a half months have passed since my last article , "Regeneron Pharmaceuticals: My Highest Conviction Pharmaceutical Pick for 2025," and during that time, its stock price has risen by 2.5%.With over two decades of dedicated experience in investment, Allka Research has been a guiding force for individuals seeking lucrative opportunities. Its conservative approach sets it apart, consistently unearthing undervalued assets within the realms of ETFs, commodities, technology, and pharmaceutical compan ...

About two and a half months have passed since my last article , "Regeneron Pharmaceuticals: My Highest Conviction Pharmaceutical Pick for 2025," and during that time, its stock price has risen by 2.5%.With over two decades of dedicated experience in investment, Allka Research has been a guiding force for individuals seeking lucrative opportunities. Its conservative approach sets it apart, consistently unearthing undervalued assets within the realms of ETFs, commodities, technology, and pharmaceutical compan ...

Regeneron Pharmaceuticals (NASDAQ:REGN) announced on Friday that the U.S. FDA approved a label expansion for its anti-cholesterol agent Evkeeza, marketed globally with Ultragenyx Pharmaceuticals (NASDAQ:RARE). Accordingly, the injectable, first approved in 2021 for adults and adolescents with homozygous familial hypercholesterolemia ((HoFH)), will also be ...

FDA approval extends the indication of Evkeeza to treat younger patients with homozygous hypercholesterolemia (HoFH) HoFH is an inherited condition characterized by extremely high levels of low-density lipoprotein cholesterol (LDL-C) Initial Evkeeza approval based on placebo-controlled trial showing Evkeeza, when added to standard lipid-lowering therapies, could lower LDL-C by about 50% compared to placebo in this high unmet need population TARRYTOWN, N.Y., Sept. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron Phar ...

PresentationGood morning, everyone. My name is Will Pickering. I cover U.S. biotech at Bernstein. Very pleased today to have Regeneron Pharmaceuticals with us. I'm joined by CFO, Chris Fenimore; and SVP and Head of Investor Relations, Ryan Crowe. Thanks so much. And Ryan, let me hand it over to you for some forward-looking statements.Ryan CroweSenior Vice President of Investor Relations & Strategic Analysis Thanks, Will, for having us at the Bernstein Conference. Always great to be here and Sanitova to all ...

**公司：Regeneron Pharmaceuticals (NasdaqGS:REGN)** [1] 核心产品表现与展望 **EYLEA HD** * 第二季度需求环比增长16% 第一季度需求环比增长5% [4] * 增长归因于商业团队在视网膜领域对医生和患者的教育工作 强调产品的疗效、安全性、给药灵活性和持久性 [4] * 当前面临三大市场阻力：每四周给药方案（Q4 dosing）的批准、预充式注射器（prefilled syringe）的批准、以及视网膜静脉阻塞（RVO）适应症的批准 [5][6] * 预充式注射器的PDUFA日期在10月下旬 RVO和Q4给药的sBLA的PDUFA日期在11月下旬 [7][8] * 公司认为Catalent工厂的CMC问题（由Scholar Rock的CRL间接证实）不会影响EYLEA HD的PDUFA日期 对解决这些问题并如期获得批准保持信心 [8][9] * 公司认为其提交的申请在当前形式下是可批准的 [10] **EYLEA 2mg (应对生物类似药)** * 目前市场上有一个生物类似药 其市场份额侵蚀被描述为“渐进式”（gradual） [11] * 在财务敏感的视网膜诊所细分市场中 生物类似药的接受度更高 [11] * Biocon和Sandoz的生物类似药将分别于2026年下半年和2026年第四季度进入市场 预计将带来额外的定价压力 [11] * 公司的首要目标是尽可能快地将患者从EYLEA 2mg转换为EYLEA HD [12] **DUPIXENT** * 被描述为“一个管道加一个产品”（a pipeline and a product） 在美国有8个已获批适应症 [15] * 所有适应症表现都非常出色 成熟适应症（如哮喘、特应性皮炎）继续增长 新适应症（如COPD、CSU、大疱性类天疱疮）的推出活动正在进行 [15] * 针对COPD 公司与赛诺菲合作的专职肺部团队正在积极推广 反馈非常积极 已有超过70%的顶级肺科医生开具处方 [17][18] * 公司收到了关于潜在限制直接面向消费者（DTC）广告的政府通函 但强调其所有宣传材料都遵循了公平、平衡、教育的原则 [19] 研发管线进展 **肿瘤学 (Linvoseltamab / Linezyth)** * 用于多发性骨髓瘤的双特异性抗体 于2024年7月获批 上市仅数月 [24] * 在后期治疗线中 其交叉试验数据优于竞争对手（Janssen和Pfizer的BCMAxCD3抗体） [24] * ambitious开发计划：2024年底启动Linezyth与carfilzomib联合用于二线及以上治疗的研究；2025年底/2026年初启动用于新诊断（适合与不适合移植）患者的研究 [26][27] * 在冒烟型骨髓瘤中 早期数据显示出比Darzalex单药疗法更优的缓解率（100% vs 8.8%）和MRD阴性率 [28] * 在轻链淀粉样变性中也显示出有前景的早期数据 [29] **Libtayo (LAG-3) in Melanoma** * 与pembrolizumab联合用于一线晚期黑色素瘤的研究 使用pembrolizumab作为对照组 [30] * 早期人体研究显示缓解率在55%-60%以上 中位无进展生存期（mPFS）为24个月 完全缓解率（CR率）约25% [30] * 成功的关键是击败pembrolizumab 并能在交叉试验中优于已批准的免疫疗法组合（如Opdualag 其mPFS为10个月 缓解率约43%） [30][31] * 头对头对比Opdualag的研究预计在2027年上半年读出数据 [33] * 肺癌数据预计在2026年初读出 [31] **补体系统 (C5 Program - Cemdisiran)** * 在重症肌无力（MG）中 siRNA单药cemdisiran每季度给药一次 在交叉试验中显示出优于现有C5抑制剂（Soliris, Ultomiris, zilucoplan）的疗效和给药间隔优势 [35] * 计划在PNH（2027年初）和地理萎缩（2027年）中读取更多数据 [36] **Factor XI (抗凝剂)** * 目标是扩大抗凝剂的使用 在保持或提升疗效的同时显著降低出血风险 [39] * 已启动针对膝关节置换术后VTE的III期研究 评估两种抗体：REGN7508（催化域抗体 最大化抗血栓活性）和REGN9933（A2靶向抗体 潜在更好的安全性） [39][40] * 2024年启动卒中预防的II期研究 后续还有更多适应症的研究计划在2024年底和2026年初启动 [40][41] * 投资决策不依赖于竞争对手Milvexian的数据 [42] **肥胖症** * 战略重点不是减重本身 而是减重的“质量”（即减少脂肪 保留肌肉） [45] * myostatin抗体（trivagramab）与semaglutide联用 可将瘦体重损失减少约一半（从33%降至约一半） [43] * 在此基础上添加garetosmab可保留80-85%的瘦体重 但存在安全性问题 [44] * 公司授权了GLP-1/GIP双激动剂olorepatide 计划在普通肥胖和2型糖尿病中推进其单药III期项目 预计2025年启动 并探索与其他管线资产的组合 [45][46] 资本配置与战略 **资本配置优先顺序** * 首要任务是内部研发投资 [50] * 其次是外部机会（包括技术许可与合作 如与Alnylam、Intellia的交易） M&A并非主要焦点 [50] * 最后是股东回报 包括股票回购（2024年上半年回购约22亿美元）和于2024年实施的股息计划 [51] **研发投资与并购策略** * 不基于短期收益目标管理业务 投资决策基于驱动长期股东价值 [52] * 对并购持开放态度 但强调竞争激烈且对价格敏感 尚未找到合适的标的 目前策略仍以“补强”（bolt-on）为主 [54][55] * 强大的资产负债表提供了执行交易的灵活性 [55] 其他重要内容 **公司前景与管线广度** * 管理层认为当前管线的广度和深度是“前所未有的”（unprecedented） 是持有公司股票的最令人兴奋的理由 [57] * 公开的管线只是公司正在进行的研发工作的“冰山一角” 在炎症、眼科、罕见病（如FOP、遗传性耳聋）等领域还有大量临床前机会 [58][59] * 遗传学（Genetics）继续是公司探索疾病的指南针 [59]

Thank you for reading my research on Seeking Alpha. If you want to learn even more about my method and how I discover these investment opportunities, please check out my subscription marketplace service, Compounding Healthcare , and sign up for a free trial.It has been roughly five months since my previous Regeneron Pharmaceuticals (NASDAQ: REGN ) article , where I discussed how Regeneron was still a “biotech juggernaut” thanks to their key brands of Dupixent, EYLEA, and Libtayo performing well, while other ...

Wall Street paused on Tuesday after three straight sessions of strong gains that pushed major large-cap indices to fresh records.The S&P 500 slipped 0.2% to 6,682.62, while the Nasdaq 100 dipped 0.2%. The Dow Jones Industrial Average edged up 0.1% to 46,418.66, and small caps outperformed, with the Russell 2000 jumping 0.6%.PSKY shares are testing new highs. Get the complete picture here.On the economic front, the S&P Global U.S. Composite PMI slowed to 53.6 in September from 54.6 in August, signaling softe ...