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argenx Reports Full Year 2023 Financial Results and Provides Fourth Quarter Business Update
Newsfilter· 2024-02-29 06:00
财务表现 - 2023年第四季度全球净产品销售额达3.74亿美元,全年达12亿美元,同比增长分别达116%和197% [1][5][10] - 2023年全年总营业收入12.69亿美元,同比增长185%,其中产品净销售额11.91亿美元,合作收入3550万美元 [10][12] - 2023年研发费用8.59亿美元,同比增长30%,销售及管理费用7.12亿美元,同比增长51% [10][13][14] - 2023年净亏损2.95亿美元,较2022年7.1亿美元亏损大幅收窄,每股亏损5.16美元 [10][16] - 截至2023年底现金及金融资产达31.8亿美元,同比增长45% [11][16] 产品进展 - VYVGART系列产品已在30多个国家获批治疗全身型重症肌无力(gMG),包括静脉注射和皮下注射两种剂型 [4] - 2024年1月日本批准VYVDURA用于gMG治疗,2月英国批准VYVGART SC,均包含血清阴性患者 [5] - VYVGART Hytrulo用于慢性炎性脱髓鞘性多发性神经病(CIDP)的补充生物制剂许可申请(sBLA)获FDA优先审评,PDUFA目标日期为2024年6月21日 [1][5] - 2024年计划在瑞士、澳大利亚、沙特、韩国等国家寻求gMG适应症批准,并通过再鼎医药在中国寻求VYVGART SC批准 [5] 研发管线 - 计划2024年报告6项二期概念验证试验数据,包括Sjogren综合征、PC-POTS及三种肌炎亚型的2/3期ALKIVIA研究 [1][8] - 主力产品efgartigimod计划2025年前在15种自身免疫适应症中获批或进入开发阶段 [7] - 推进早期管线项目包括C2抑制剂empasiprubart(MMN、DGF、DM适应症)和MuSK激动剂ARGX-119(CMS和ALS适应症) [7][8] - 免疫学创新计划(IIP)已提名4个新候选药物,包括靶向FcRn的ARGX-213和靶向IL-6的ARGX-109 [9] 商业拓展 - 通过多维扩张计划扩大患者覆盖范围,包括MG治疗早期阶段患者和通过全球监管批准的新患者群体 [4] - 计划2024年启动注册研究扩大VYVGART标签至更广泛MG人群,包括血清阴性患者 [6] - 2024年上半年预计更新预充式注射器开发进展,相关临床研究可能支持gMG和CIDP适应症批准 [6]
Is a Surprise Coming for argenx (ARGX) This Earnings Season?
Zacks Investment Research· 2024-02-28 14:40
ARGX盈利预期 - argenx SE (ARGX) 可能是一家即将在财报季度取得成功的公司[1] - 分析师最近对ARGX的盈利预期进行了有利的修订,这通常是盈利超预期的前兆[2] - 最准确的估算显示,ARGX本季度每股亏损83美分,而更广泛的Zacks共识估算为每股亏损1.23美元,这表明分析师最近提高了对ARGX的估算[3]
argenx to Present at Upcoming Investor Conferences
Newsfilter· 2024-02-26 06:00
February 26, 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 the management team will participate in the following investor conferences in March: TD Cowen 44th Annual Health Care Conference. Fireside chat on Monday, March 4, 2024 at 11:10 a.m. ET in Boston, MA.Leerink Global Biopharma Conference. Fireside chat on Monday, March 11, 2024 at 2 ...
argenx to Present at Upcoming Investor Conferences
Globenewswire· 2024-02-26 06:00
February 26, 2024Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that members of the management team will participate in the following investor conferences in March: TD Cowen 44th Annual Health Care Conference. Fireside chat on Monday, March 4, 2024 at 11:10 a.m. ET in Boston, MA.Leerink Global Biopharma Conference. Fireside chat on Monday, March 11, 2024 at 2:40 ...
argenx to Report Full Year 2023 Financial Results and Fourth Quarter Business Update on February 29, 2024
Globenewswire· 2024-02-22 06:00
February 22, 2024Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Thursday, February 29, 2024 at 2:30 PM CET (8:30 AM ET) to discuss its full year 2023 financial results and provide a fourth quarter business update. A webcast of the live call may be accessed on the Investors section of the argenx website at a ...
3 Biotech Stocks That Could Be Multibaggers in the Making: February Edition
InvestorPlace· 2024-02-22 03:08
Xenon Pharmaceuticals (XENE) - 联邦储备局计划降低利率,将使投资者更容易进入风险较高的经济和股市领域[1] - 生物技术股票通常根据其新技术或药物的试验和批准而波动,具有投机性[1] - Xenon Pharmaceuticals (XENE)开发了大量的神经疗法产品,目前主要在加拿大,市场对其表现持乐观态度[4] - Xenon Pharmaceuticals发布了XEN1101第三阶段项目,用于治疗重度抑郁症[5] - 分析师预计该公司未来12个月的每股收益将增长107.8%[6] Argenx (ARGX) - 前瞻市盈率为538.0倍,市场愿意为未来预期收益支付高昂的价格[8] - Argenx (ARGX)公司在自身网站上展示了其产品管道,该公司在自身产品的研发上表现出色[10] - ARGX-118项目目前处于第一阶段,可能很快引起市场关注,预计未来EPS增长约240.0%[13] IntraCellular Therapies (ITCI) - IntraCellular Therapies (ITCI)在处理神经疾病方面表现出色,分析师预计今年EPS增长225.8%[16]
argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy
Newsfilter· 2024-02-20 06:00
Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2024 If approved, VYVGART® Hytrulo will be the first neonatal Fc receptor (FcRn) blocker to treat CIDP February 20, 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 that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics ...
5 medical stocks growing earnings by triple digits
MarketBeat· 2024-02-06 15:46
Key PointsThe healthcare sector is quickly heating up in all the fundamental ways professional traders seek. Within it, you can spot five stocks calling for new moves to the upside, backed by similar tailwinds.Analysts see the same factors at play and boldly project triple-digit EPS growth in all of them.5 stocks we like better than Axsome TherapeuticsWhile most of the market focuses on hyper-growth technology stocks rewarded by Wall Street as long as they mention the word "artificial intelligence" in their ...
argenx: Upgrading To 'Strong Buy' On Vyvgart's Q4 Sales, Empasiprubart Data, Pipeline Expansion
Seeking Alpha· 2024-02-01 12:22
Christoph Burgstedt Shares of argenx (NASDAQ:ARGX) have somewhat recovered from the negative reaction to the second late-stage clinical failure of Vyvgart in a row - phase 3 trial in immune thrombocytopenia ('ITP') and phase 3 trial in pemphigus vulgaris ('PV'). The recovery was probably driven by several factors - bargain hunters and the overall positive industry sentiment since early November and the company providing a bullish commercial and pipeline update ahead of and at the JPMorgan Healthcare Confere ...
argenx Announces Approval of VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Japan for Generalized Myasthenia Gravis
Newsfilter· 2024-01-18 06:00
argenx公司新药批准 - argenx公司宣布日本卫生劳动省批准VYVDURA用于治疗成人全身性重症肌无力症患者[2] - VYVDURA的批准基于来自第3期ADAPT-SC研究的积极结果,该研究证实了VYVDURA的疗效[3] - VYVDURA是一种皮下注射药物,结合了efgartigimod alfa和递归人透明质酸酶PH20,利用Halozyme的ENHANZE®药物递送技术[4]