July 18, 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, July 25, 2024 at 2:30 PM CET (8:30 AM ET) to discuss its half year 2024 financial results and provide a second quarter business update. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.co ...

文章核心观点 - 中国国家药品监督管理局(NMPA)批准了efgartigimod SC(皮下注射)用于治疗成人抗乙酰胆碱受体(AChR)抗体阳性的广泛型重症肌无力(gMG)患者[3] - efgartigimod SC与IV(静脉注射)相比,在临床获益和安全性方面保持一致,这一点在ADAPT-SC III期临床试验中得到证实[2][7] - efgartigimod SC的上市为中国gMG患者带来了新的治疗选择,提高了治疗的灵活性和可及性[4][6] 公司相关 - 阿尔真克斯公司与再鼎医药公司在中国大陆、香港、澳门和台湾地区(大中华区)拥有efgartigimod的独家许可协议[12] - 阿尔真克斯公司致力于开发创新性抗体药物,旨在为患有严重自身免疫疾病的患者带来福音[15] - 再鼎医药公司是一家创新型商业化生物制药公司,专注于肿瘤、自身免疫疾病、传染病和神经科学领域的新药研发和商业化[16] 行业相关 - 中国约有17万人患有gMG,其中85%为AChR抗体阳性[13] - 现有的治疗方法,如乙酰胆碱酯酶抑制剂、糖皮质激素和免疫抑制剂等,只能部分恢复患者的肌力[13] - efgartigimod SC的上市为gMG患者带来了更多的治疗选择,满足了临床上的巨大未满足需求[4][6]

文章核心观点 - 公司正在开发新药物,旨在为严重自身免疫性疾病患者带来转变性治疗 [2] - 公司已经证实多焦性运动神经病(MMN)和慢性炎症性脱髓鞘性多发性神经病(CIDP)是由自身抗体介导的疾病 [2] - 公司正在开发针对疾病生物学的创新药物,以期为患者带来超越症状管理的益处 [2] 关于MMN的研究 - 第2期ARDA研究支持empasiprubart作为MMN的潜在新治疗选择 [2][12][13] - 与安慰剂相比,empasiprubart治疗可将静脉注射免疫球蛋白(IVIg)再次治疗的风险降低91% [2] - empasiprubart可改善握力和肌肉力量,提高患者日常活动能力 [2] - empasiprubart耐受性良好,大多数不良事件为轻度或中度 [3] 关于CIDP的研究 - ADHERE研究数据支持VYVGART Hytrulo在CIDP患者中具有持续的疗效和安全性 [4][14][15] - VYVGART Hytrulo治疗组患者功能改善持续,而安慰剂组患者各项疾病评分均有临床意义的恶化 [4][5][6] - 长期延长研究中,98.9%的参与者遵医嘱服药,86%的患者在第24周仍在研究中 [6] - VYVGART Hytrulo的安全性在ADHERE和ADHERE+研究中保持一致,暴露时间增加未增加不良事件发生率 [7] - VYVGART Hytrulo于2024年6月21日获得FDA批准,用于治疗成人CIDP患者 [8] 关于公司 - 公司致力于开发创新的抗体药物,以改善严重自身免疫性疾病患者的生活 [30] - 公司通过免疫创新项目(IIP)与顶尖学术研究人员合作,旨在将免疫学突破转化为世界级的新型抗体药物 [30] - 公司已开发并商业化美国、日本、以色列、欧盟、英国、加拿大和中国首个获批的FcRn阻滞剂 [30]

ARDA study data show potential for empasiprubart to drive functional improvement and reduced risk of relapse for multifocal motor neuropathy (MMN) patients ADHERE+ data show durability of functional improvements with VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), which is FDA approved for use in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) June 25, 2024 – 4:30pm EDT Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed t ...

argenex SE (ARGX) shares soared 11.7% in the last trading session to close at $440.59. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 7.5% gain over the past four weeks. The sudden rise in the stock price was observed after the company announced that the FDA approved its subcutaneously administered Vyvgart Hytrulo (efgartigimod) for a second indication — chronic inflammatory demyelinating polyneuropathy (CIDP). The drug has been ...

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 oth ...

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 & Nasdaq: ARGX), a global immunology company committed t ...

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 committed t ...

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 immunolo ...