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Press Release: Dupixent® FDA approved as first and only treatment indicated for children aged 1 year and older with eosinophilic esophagitis (EoE)
Newsfilter· 2024-01-26 03:30
Dupixent® FDA approved as first and only treatment indicated for children aged 1 year and older with eosinophilic esophagitis (EoE) Approval based on Phase 3 EoE KIDS trial showing a greater proportion of children taking Dupixent achieved histological remission compared to placebo Expanded indication marks second disease for which Dupixent is approved in children this young, underscoring the commitment to bringing therapies to young patients with significant unmet needs EoE is one of five FDA-approved i ...
Top 40 High School Scientists in Prestigious Regeneron Science Talent Search to Compete for $1.8 Million in Awards
Newsfilter· 2024-01-25 01:00
TARRYTOWN, N.Y. and WASHINGTON, D.C., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Society for Science (the Society) today announced the top 40 finalists in this year's Regeneron Science Talent Search, the nation's oldest and most prestigious science and math competition for high school seniors. The competition, now in its 83rd year, has consistently identified young innovators who combine their STEM talent with dedication and leadership skills to drive society forward ...
Regeneron (REGN), Sanofi's Dupixent Gets Label Update in US
Zacks Investment Research· 2024-01-18 01:26
Regeneron Pharmaceuticals, Inc. (REGN) and partner Sanofi (SNY) announced that the FDA has updated the label for Dupixent (dupilumab) for the indication of atopic dermatitis.Per the latest FDA update, efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement will be added to the existing label.The label update is based on data from the late-stage LIBERTY-AD-HAFT study, which evaluated the efficacy and safety of Dupi ...
Regeneron (REGN) Is Up 3.97% in One Week: What You Should Know
Zacks Investment Research· 2024-01-13 02:32
Momentum investing is all about the idea of following a stock's recent trend, which can be in either direction. In the 'long' context, investors will essentially be "buying high, but hoping to sell even higher." And for investors following this methodology, taking advantage of trends in a stock's price is key; once a stock establishes a course, it is more than likely to continue moving in that direction. The goal is that once a stock heads down a fixed path, it will lead to timely and profitable trades.Even ...
Regeneron CEO says the next big thing for biotech isn't AI, it's gene therapy
CNBC· 2024-01-10 08:12
基因研究与治疗 - Regeneron首席执行官Leonard Schleifer在与CNBC的Jim Cramer的访谈中强调了基因研究在行业中的重要性[1] - Schleifer表示,将基因与疾病相关联将推动制药行业的发展,创新治疗可以修复某些基因并沉默其他基因[3] - Regeneron在2023年10月分享了基因治疗改善一名患有罕见疾病导致“严重遗传性听力丧失”的儿童听力的初步结果,这种特定的基因治疗是与Decibel Therapeutics合作开发的[4] 新的药物研发 - Regeneron正在开发新的癌症治疗方法,以及可以对抗由GLP-1药物引起的肌肉流失的药物,这些药物是糖尿病和减肥药物,如Ozempic或Mounjaro[5] - 公司计划在今年晚些时候开始测试新的治疗方法,以提高与标准GLP-1药物结合时的更高质量的减肥效果[6]
Regeneron (REGN) Down as Q4 Eylea Preliminary Sales Disappoint
Zacks Investment Research· 2024-01-10 01:47
Eylea销售情况 - Regeneron Pharmaceuticals, Inc. (REGN)的股价下跌1.13%,因为公司报告了Eylea主力药物销售额令人失望[1] - Eylea(阿非利切普)和Eylea HD(Eylea的高剂量)在美国销售额为14.6亿美元,超过了Zacks Consensus Estimate的14.5亿美元[2] - Eylea在美国的销售额为13.4亿美元,Eylea HD在2023年第四季度的销售额为1.23亿美元,这是Eylea HD推出后的第一个完整季度[3] - FDA在2023年8月批准了阿非利切普8毫克用于治疗患有湿性年龄相关性黄斑变性(wAMD)、糖尿病性黄斑水肿(DME)和糖尿病视网膜病变的患者,品牌名为Eylea HD[4] - Eylea的销售令投资者失望,股价因此下跌[5] - Eylea的销售在2023年受到来自Roche的Vabysmo的竞争压力[8] - 竞争也影响了第四季度的销售[10] - 预计Eylea HD的销售将进一步增长,抵消Eylea销售下降[13] 其他产品销售情况 - Dupixent的表现出色,受到在批准适应症中持续强劲需求的推动,包括特应性皮炎、哮喘、慢性鼻窦炎伴有鼻息肉、嗜酸性食道炎和结节性瘙痒症[15] - Libtayo用于晚期或无法通过手术或放疗治愈的鳞状细胞癌,2023年Libtayo的销售表现强劲,预计该药物在2024年的销售额将超过10亿美元[17] - FDA授予fianlimab(LAG-3抗体)与Libtayo(西米普利单抗)联合治疗转移性黑色素瘤患者的一线治疗快速通道指定,正在进行III期研究[20] 新药研发及批准情况 - 其他有前途的肿瘤候选药物包括odronextamab、linvoseltamab、ubamatamab fianlimab、REGN5837和REGN4336[18] - 2023年9月,FDA接受了odronextamab的生物制品许可申请,用于治疗成人复发/难治性滤泡性淋巴瘤和至少经历两种先前系统治疗后进展的复发/难治性弥漫性大B细胞淋巴瘤患者,监管机构已设定2024年3月31日为目标行动日期,欧盟也已提交了odronextamab的监管申请[19] - Regeneron在肥胖领域的管线中也有有前途的候选药物[21]
Regeneron Pharmaceuticals Inc. (REGN) 42nd Annual JPMorgan Healthcare Conference - (Transcript)
2024-01-09 09:25
产品销售 - 公司的EYLEA HD在8月份成功推出,首季销售额达到1.23亿美元,表现优异[15] - DUPIXENT在前9个月的销售额达到了近84亿美元,患者数量超过75万人,在五个适应症上获得批准[18] - DUPIXENT在COPD领域取得了突破性成果,首次实现了临床意义上的减少发作和改善肺功能[40] 新产品和技术研发 - 公司在肿瘤领域取得了重要进展,目标是在本十年末成为领先公司,已经提交了多个产品的审批申请[22] - 公司的免疫肿瘤学努力旨在通过激活免疫系统来对抗癌症,已经验证了三种不同类别的免疫调节剂[29] - 通过组合两种检查点抑制剂,公司希望实现对癌症的增效效果,旨在在今年年底前提供关键数据[33] 新策略和有价值信息 - 公司发现一种新的组合方法,可能有助于消除过敏,已在非人灵长类动物中得到验证[47] - 临床验证的抗体可以保护和增长肌肉,改善体重减轻质量[52] - GPR75靶点可能提供全新的对抗肥胖的机制[54] 市场扩张和并购 - 公司在第一线黑色素瘤试验中看到了一些令人振奋的数据,如果能够保持一致,将会改变患者的治疗范式[99] - 在最高剂量下,患有晚期前列腺癌的患者在三周内完全消除了所有癌细胞的痕迹[101] - 公司在动物模型中看到的几乎所有情况都被预测到,这也是为什么公司在项目中具有如此高的成功率[105]
Regeneron Pharmaceuticals Inc. (REGN) 42nd Annual JPMorgan Healthcare Conference - (Transcript)
Seeking Alpha· 2024-01-09 09:25
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) 42nd Annual JPMorgan Healthcare Conference Call January 8, 2024 5:15 PM ET Company Participants Chris Schott - JPMorgan Leonard Schleifer - Board Co-Chair, President and Chief Executive Officer George Yancopoulos - Board Co-Chair, Co-Founder, President and Chief Scientific Officer Marion McCourt - Executive Vice President, Commercial Chris Schott Good afternoon, everybody. I'm Chris Schott from JPMorgan, and it's my pleasure to be introducing Regeneron today. Fro ...
Why I Expect Regeneron To Keep Delivering For Investors In 2024 (Upgrade)
Seeking Alpha· 2024-01-09 07:51
SolStock/E+ via Getty Images Investment Overview Shares in Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), the Tarrytown, New York State-based Pharma company, have been rising sharply in recent months, from $725 in mid-August 2023, to >$910 at the time of writing - up >25%. Regeneron's share float is only just over 100m, and its market cap valuation currently hovers around the $100bn mark. Arguably, that is a generous valuation for a company that has generated top line revenues of $6.6bn, $8.5bn, $16.1bn, an ...
Regeneron hints at 4Q US sales of Eylea below expectations
Proactive Investors· 2024-01-09 02:42
Proactive Investors团队 - Stephen Gunnion是Proactive Investors的高级财经记者和广播员[2] - Proactive的新闻团队遍布全球主要的金融和投资中心[4] Proactive的报道范围 - Proactive专注于中小市值市场,同时也让社区了解蓝筹公司、大宗商品和更广泛的投资故事[5] Proactive的新闻内容 - Proactive团队提供市场上跨领域的新闻和独特见解,包括生物技术和制药、矿业和自然资源、电池金属、石油和天然气、加密货币以及新兴数字和电动车技术[6]