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Press Release: Dupixent® late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM
Newsfilter· 2024-05-21 02:15
  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 inflammationData support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted thera ...
Dupixent® (dupilumab) Late-Breaking Data from NOTUS Confirmatory Phase 3 COPD Trial Presented at ATS and Published in The New England Journal of Medicine
Newsfilter· 2024-05-21 02:15
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: ...
More than $9 Million Awarded to High School Scientists and Engineers at the Regeneron International Science and Engineering Fair 2024
Newsfilter· 2024-05-18 01:45
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 ...
More than $9 Million Awarded to High School Scientists and Engineers at the Regeneron International Science and Engineering Fair 2024
globenewswire.com· 2024-05-18 01:45
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 larges ...
Regeneron Pharmaceuticals Inc (REGN) RBC Capital Markets Global Healthcare Conference (Transcript)
2024-05-15 00:42
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]
Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of Adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP)
Newsfilter· 2024-05-13 13:00
If approved, Dupixent would be the first treatment in the U.S. indicated for adolescents aged 12-17 years with inadequately controlled CRSwNP, a condition driven in part by underlying type 2 inflammation that obstructs the sinuses and nasal passages and can lead to a loss of sense of smell Current treatment options for adolescents with CRSwNP leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps TARRYTOWN, N.Y. and PARIS, May 13, 2024 (GLOBE NEWSWIRE) -- Regeneron ...
Latest DB-OTO Results Show Dramatically Improved Hearing to Normal Levels in a Child with Profound Genetic Deafness within 24 Weeks and Initial Hearing Improvements in a Second Child at 6 Weeks
Newsfilter· 2024-05-08 18:00
Preliminary data detailed in an ASGCT oral presentation include results for one of the youngest children in the world to receive a gene therapy for genetic deafness Ongoing Phase 1/2 CHORD trial is currently enrolling infants and children in the U.S., UK and Spain TARRYTOWN, N.Y., May 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced that the investigational gene therapy DB-OTO improved hearing to normal levels in one child (dosed at 11 months of age) within 24 weeks ...
Regeneron(REGN) - 2024 Q1 - Earnings Call Transcript
2024-05-03 00:28
财务数据和关键指标变化 - 2024年第一季度收入增长7%,主要由于Sanofi合作收入和Libtayo全球净销售额增长,分别增长14%和45% [58] - Dupixent全球净销售额增长24%至31亿美元 [50] - EYLEA HD第二个完整季度在美国市场销售额达2亿美元,超过最近上市的其他抗VEGF药物 [45][46] 各条业务线数据和关键指标变化 - Dupixent在所有5个适应症中的新处方份额均领先,在3个适应症中达到了销售额10亿美元的里程碑 [51] - Libtayo在非黑色素瘤皮肤癌和肺癌领域继续保持领导地位,销售额增长44% [53] - EYLEA和EYLEA HD在抗VEGF类药物中的市场份额达45% [46][47] 各个市场数据和关键指标变化 - 美国Dupixent销售额增长17%至22亿美元,受益于需求持续增长和季节性因素 [50] - 美国EYLEA HD销售额增长63%至2亿美元,受益于医生对其疗效和安全性的认可度提高 [46][47] - 欧洲和日本EYLEA 8mg销售额增长2% [59] 公司战略和发展方向及行业竞争 - 公司正在开发多项差异化的管线产品,包括Dupixent在COPD和食物过敏、itepekimab在COPD、linvoseltamab在多发性骨髓瘤等 [16][19][20][25][26][30][31] - 公司正在评估将Dupixent与linvoseltamab联合用于治疗严重过敏,以消除导致过敏的IgE抗体 [25][26] - 公司正在评估将肌肉保护抗体与GLP-1/GIP受体激动剂联合用于治疗肥胖,以保留肌肉量 [37][38][39] - 公司正在加快推进基因治疗管线,包括用于听力损失的DB-OTO和用于TTR淀粉样变性的Intellia-2001 [40][41][42] 管理层对经营环境和未来前景的评论 - 公司在2024年第一季度取得了良好的财务业绩,反映了商业组合的强劲表现和未来增长机会 [13][58] - 公司有望在未来几年推出多项差异化的新产品,为公司带来可持续的长期增长 [14][22] - 公司有信心Dupixent在COPD适应症获批后将带来重大增长,同时itepekimab也有望满足COPD患者的未被满足需求 [16][19] - 公司认为linvoseltamab有望成为多发性骨髓瘤晚期患者的最佳选择 [21][53] 问答环节重要的提问和回答 问题1 **Colin Bristow 提问** 询问公司肌肉保护肥胖项目与竞争对手的差异以及关注Lilly Bimagrumab的Phase 2数据 [74] **George Yancopoulos 回答** 公司针对肌肉保护开发了针对两个特定因子的单抗,而竞争对手的方法可能会影响更多不相关的因子,公司方法可能具有更好的安全性。公司将关注Lilly的数据,了解是否存在任何差异化机会 [75][76] 问题2 **Evan Seigerman 提问** 询问FDA在肌肉保护肥胖项目中可能接受的终点指标 [80] **George Yancopoulos 回答** 最简单的终点指标可能是单纯的体重下降。如果没有体重下降,但能显示出更好的脂肪损失和肌肉保护,也可能被接受,比如代谢参数或功能性指标。公司将在Phase 2研究中重点关注脂肪和肌肉的变化情况 [81][82][83] 问题3 **Tyler Van Buren 提问** 询问公司食物过敏项目的预期结果以及患者需要服用Dupixent的时间长度 [94] **George Yancopoulos 回答** 公司希望能在最初的几例患者中看到IgE水平明显下降等积极迹象。如果结果像动物实验一样,患者可能只需短期治疗即可获得长期保护,但也可能需要长期服用Dupixent以防止IgE的再次产生。Dupixent相比其他免疫调节剂更安全,适合长期使用 [95][99][100][111]
Regeneron (REGN) Q1 Earnings, Sales Miss on Lower Eylea Sales
Zacks Investment Research· 2024-05-02 23:06
Regeneron Pharmaceuticals, Inc. (REGN) delivered lower-than-expected first-quarter 2024 results due to declining sales of its lead drug, Eylea (aflibercept).  The company reported earnings per share (EPS) of $9.55, which missed the Zacks Consensus Estimate of $10.20. The company recorded EPS of $10.09 in the year-ago period.Higher expenses and lower revenues adversely impacted the bottom line.Total revenues declined 1% year over year to $3.14 billion, which also missed the Zacks Consensus Estimate of $3.19 ...
Regeneron (REGN) Reports Q1 Earnings: What Key Metrics Have to Say
Zacks Investment Research· 2024-05-02 22:36
For the quarter ended March 2024, Regeneron (REGN) reported revenue of $3.15 billion, down 0.5% over the same period last year. EPS came in at $9.55, compared to $10.09 in the year-ago quarter.The reported revenue represents a surprise of -1.53% over the Zacks Consensus Estimate of $3.19 billion. With the consensus EPS estimate being $10.20, the EPS surprise was -6.37%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expe ...