Loading...Loading...Friday, the FDA approved Argenx SE’s ARGX Vyvgart Hytrulo for use in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).Vyvgart Hytrulo is approved for CIDP as a once-weekly 30-to-90-second subcutaneous injection. It is the first and only neonatal Fc receptor (FcRn) blocker approved for CIDP.CIDP is an autoimmune disorder in which the body’s immune system attacks the myelin that insulates and protects the body’s nerves. It causes muscle weakness, numbness, and other s ...

文章核心观点 - 美国FDA批准了argenx公司的药物Vyvgart Hytrulo用于治疗慢性炎症性脱髓鞘性多发性神经病(CIDP),这是该药物获批的第二个适应症 [1][2][3] - Vyvgart Hytrulo是一种每周一次30-90秒皮下注射的药物,是30年来首个获批治疗CIDP的新机制药物 [2][3] - 该药物在ADHERE III期临床试验中显示,与安慰剂相比,可将CIDP患者复发风险降低61% [4] - CIDP是一种罕见且严重的自身免疫性外周神经系统疾病,在获批前治疗选择有限,主要包括糖皮质激素和血浆置换疗法 [5][6] - 与现有治疗只能缓解CIDP症状不同,Vyvgart Hytrulo可改善患者的活动能力和感觉功能,69%的患者显示临床改善 [6] - 该药物的批准为公司带来了商业潜力,argenx公司在重症肌无力(gMG)适应症已成为市场领导者,未来也有望在CIDP领域占据主导地位 [7] 公司相关 - argenx公司目前所有产品收入来自Vyvgart和Vyvgart Hytrulo的销售,2024年第一季度产品销售额同比增长83%,环比增长6% [7] - 公司还在评估Vyvgart/Vyvgart Hytrulo在膜性肾病(MN)和狼疮性肾炎(LN)适应症的临床研究 [8] - 公司决定终止在COVID-19后性正位性心动过速综合征(PC-POTS)适应症的药物开发,因中期试验数据未显示临床改善 [9] 行业相关 - 泰科药业(Takeda)的皮下注射免疫球蛋白制剂Hyqvia,也于今年1月获批用于成人CIDP的维持治疗 [10][11]

VYVGART® Hytrulo is first and only neonatal Fc receptor (FcRn) blocker approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP) First novel, precision mechanism of action in more than 30 years for patients with CIDP Third approved indication for VYVGART® and VYVGART Hytrulo franchise Management to host conference call on June 21, 2024 at 11:00pm CET (5:00pm ET) June 21, 2024, 4:40pm ET   Amsterdam, the Netherlands – argenx SE ((Euronext &amp, NASDAQ:ARGX), a global immunology company comm ...

VYVGART® Hytrulo is first and only neonatal Fc receptor (FcRn) blocker approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP) First novel, precision mechanism of action in more than 30 years for patients with CIDP Third approved indication for VYVGART® and VYVGART Hytrulo franchise Management to host conference call on June 21, 2024 at 11:00pm CET (5:00pm ET) June 21, 2024, 4:40pm ET   Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committe ...

R&D Day presentations to include recent Phase 2 datasets in Sjogren's disease (efgartigimod) and multifocal motor neuropathy (empasiprubart) that support advancement to Phase 3 development Next wave of innovative pipeline candidates to be introduced highlighting long-term commitment to transform autoimmunity Decision to not advance development of efgartigimod in PC-POTS based on Phase 2 ALPHA data June 17, 2024, 7:00 AM CET Amsterdam, the Netherlands – argenx SE ((Euronext &amp, NASDAQ:ARGX), a global im ...

R&D Day presentations to include recent Phase 2 datasets in Sjogren’s disease (efgartigimod) and multifocal motor neuropathy (empasiprubart) that support advancement to Phase 3 development Next wave of innovative pipeline candidates to be introduced highlighting long-term commitment to transform autoimmunity Decision to not advance development of efgartigimod in PC-POTS based on Phase 2 ALPHA data June 17, 2024, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immuno ...

June 4, 2024Amsterdam, the Netherlands – argenx ((Euronext &amp, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that members of management will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024 at 2:40 PM ET in Miami, FL. A live webcast of the fireside chat may be accessed on the Investors section of the argenx website at argenx.com/investors. ...

财务数据和关键指标变化 - 总营业收入为4.13亿美元,其中产品净销售额为3.98亿美元,同比增长83% [34][35] - 美国市场销售额为3.47亿美元,欧洲市场销售额为3100万美元,日本市场销售额为1800万美元 [35][36][37] - 营业费用为5.06亿美元,较上一季度减少5100万美元,其中销售及管理费用增加2700万美元,研发费用增加2100万美元 [39][40][41] - 净现金消耗为7500万美元,现金及现金等价物余额为31亿美元 [42] 各条业务线数据和关键指标变化 - VYVGART静脉给药患者数量持续增长,达到7500人,其中VYVGART皮下注射患者数量增长34% [12][51][52] - 欧洲市场VYVGART患者数量增长46%,主要来自德国、意大利和西班牙等国家的强劲需求 [53][54][55] - 日本市场VYVGART获批ITP适应症,新患者开始使用VYVGART治疗 [57][58] - 中国市场通过合作伙伴在第一季度新增2700名VYVGART患者 [59] 各个市场数据和关键指标变化 - 美国市场VYVGART Hytrulo新患者占比超过50%,体现了公司扩大市场份额的策略 [51][52] - 欧洲市场VYVGART销售额增长46%,主要来自德国、意大利和西班牙等国家的强劲需求 [53][54][55] - 日本市场VYVGART获批ITP适应症,新患者开始使用VYVGART治疗 [57][58] - 中国市场通过合作伙伴在第一季度新增2700名VYVGART患者 [59] 公司战略和发展方向及行业竞争 - 公司采取多维度的发展策略,包括扩大VYVGART在现有适应症的覆盖范围、拓展新的适应症以及推进管线产品的临床开发 [10][11][19][20] - 公司正在积极准备VYVGART皮下注射剂型的上市,预计将在6月底前向FDA提交申请 [16][17] - 公司正在推进VYVGART在重症肌无力无抗体阳性患者群体的III期临床试验,以扩大适应症覆盖范围 [19] - 公司决定终止ANCA相关性血管炎的适应症开发,转而专注于系统性硬化症的开发 [29][30] - 公司在自身免疫性疾病领域保持领先地位,正在不断优化研发投资组合 [31] 管理层对经营环境和未来前景的评论 - 公司CEO表示,公司正在执行既定的三大创新发展战略,包括扩大VYVGART在现有适应症的覆盖范围、推进管线产品的临床开发以及利用FcRn技术平台推进新靶点的临床前研究 [10][11] - 公司CFO表示,公司保持了良好的财务状况,现金及现金等价物余额为31亿美元,为未来发展提供了充足的资金支持 [42] - 公司COO表示,公司正在为CIDP适应症的上市做好充分准备,包括与支付方进行价值谈判、扩大销售团队规模以及提高患者和医生的认知度等 [61][62][63][64][65][66][67] 问答环节重要的提问和回答 问题1 **Tazeen Ahmad 提问** 询问公司在重症肌无力市场面临的竞争情况,以及公司的市场份额变化情况 [79] **Karen Massey 回答** 公司在重症肌无力市场面临一定竞争,但公司的市场份额仍在持续增长,尤其是VYVGART皮下注射剂型带来的新患者占比超过50%,显示公司产品的竞争力较强 [81] 问题2 **Rajan Sharma 提问** 询问公司VYVGART皮下注射剂型的审批进展情况,以及是否有可能获得加速审批 [84] **Tim Van Hauwermeiren 回答** 公司已完成生物等效性和人机工效研究,计划在6月底前向FDA提交申请。具体审批时间尚待FDA确定,但公司有信心获批 [85] 问题3 **Derek Archila 提问** 询问公司在CIDP市场的市场调研结果,患者转换意愿如何 [88] **Karen Massey 回答** 公司的市场调研显示,约88%的CIDP患者仍有残留症状,对新疗法有较强需求。但患者转换现有治疗的意愿较低,公司将通过教育医生和患者群体来提高认知,预计转换速度会较重症肌无力市场有所放缓 [89][90]

$398 million in first quarter global net product sales FDA review ongoing for CIDP sBLA with PDUFA target action date of June 21, 2024 On track to submit filing for pre-filled syringe (PFS) in second quarter 2024 Management to host conference call today at 2:30 PM CET (8:30 AM ET) May 9, 2024, 7:00 AM CET Amsterdam, the Netherlands – argenx SE ((Euronext &amp, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its ...

May 7, 2024 – 5:30pm ET Amsterdam, the Netherlands – argenx SE ((Euronext &amp, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced the results of its Annual General Meeting of shareholders held today. All items on the agenda received a majority of votes in favor except for agenda item 5 (adoption of the remuneration policy). As part of the approved resolutions: The Company's annual report and annual accounts for the fina ...