Key Takeaways ZBIO shares plunged 51.9% on Jan. 5, even after its phase III INDIGO study met the primary endpoint.Obexelimab cut IgG4-RD flare risk by 56% vs. placebo over 52 weeks and met key secondary endpoints.ZBIO plans FDA BLA filing for obexelimab in Q2 2026 and an EMA application in 2H 2026 for IgG4-RD.Zenas BioPharma (ZBIO) announced that the phase III INDIGO study, which evaluated its lead pipeline candidate, obexelimab, for treating patients with immunoglobulin G4-related disease (IgG4-RD), has me ...

公司监管申请与产品进展 - 莫德纳公司宣布已在美国、欧盟、加拿大和澳大利亚提交了其季节性流感疫苗mRNA-1010的监管申请文件，寻求在50岁及以上成人中使用的上市授权[1] - 如果获得批准，公司计划于明年将该疫苗商业化，这标志着其在呼吸道合胞病毒疫苗mResvia之外，扩展非新冠产品组合的关键一步[1] - 这些提交基于多项后期研究数据，数据显示mRNA-1010产生的免疫反应至少与葛兰素史克和赛诺菲目前销售的标准及高剂量流感疫苗同样有效[2] 公司技术平台与组合疫苗 - 该疫苗与公司其他已上市产品一样，采用莫德纳的mRNA技术平台构建[2] - 此次进展也为mRNA-1083带来了希望，这是一种针对新冠和流感的在研联合疫苗[4] - 该候选疫苗整合了公司的新冠疫苗和mRNA-1010，此前提交的申请虽已撤回，但支持mRNA-1010申请的研究数据也已提交，公司目前正在等待美国食品药品监督管理局关于该疫苗潜在申请的进一步指导[4] 公司股价与市场情绪 - 在上述公告发布后，莫德纳股价在周一上涨超过4%[3] - 过去一年，公司股价下跌了32%，而同期行业指数增长了15%[5] - 一些投资者将此次最新进展视为公司扭转股票负面情绪的广泛努力的一部分[8] 公司面临的经营挑战 - 过去几年，莫德纳一直面临其新冠疫苗销售业绩持续下滑、呼吸道合胞病毒疫苗销售表现疲软以及研发管线受挫的压力[9] - 公司最近报告其巨细胞病毒疫苗在一项后期研究中未能达到主要终点[9] - 美国对疫苗审查的加强也影响了整体疫苗需求[9] 公司遭遇的监管与财务挫折 - 去年，美国政府终止了与公司签订的总额7.66亿美元的合同，该合同涉及一款基于mRNA的禽流感疫苗的后期开发以及购买该疫苗的权利[10] - 这笔资金的损失正值莫德纳努力缩减运营开支并精简其研发管线之际[10]

Key Takeaways Galafold raked in $371.5M in the first nine months of 2025, accounting for over 80% of FOLD's product sales.Galafold benefits from broad global approvals and U.S. patent protection extending through 2038.FOLD's Pombiliti Opfolda delivered $77.5M sales in the first nine months of 2025, up 61% Y/Y.Amicus Therapeutics (FOLD) has made solid progress with its lead marketed product, Galafold (migalastat), which generates the majority of the company’s revenues.Galafold is approved for treating Fabry ...

The Tel Aviv Stock Exchange rose strongly today. The Tel Aviv 35 Index rose 2.86% to 3,845.39 points - a new record, the Tel Aviv 125 Index rose 2.55% to 3,8980.80 points; and the BlueTech Global Index rose 2.48% to 675.31 points. The All Bond corporate bond index rose 0.12% to 424.03 points. Turnover totalled NIS 5.44 billion in equities and NIS 8.35 billion in bonds. On the foreign exchange market, the representative shekel-dollar rate was set 0.19% higher from Monday, at NIS 3.164/$, and the representa ...

Corcept has also repeatedly assured investors that "[o]ur new drug application for relacorilant is progressing toward approval by the end of" 2025 and "[r]elacorilant's strong efficacy and safety profile gives us the potential to become the new standard of care for patients with hypercortisolism." Critically, Corcept's management also expressed confidence that "we're [more] confident than ever that we're on track to grow our hypercortisolism business from $3 billion to $5 billion in annual revenues in three ...

Key Takeaways Incyte's phase III study of Monjuvi combo met key goals versus R-CHOP alone in first-line DLBCL.INCY's Monjuvi/Minjuvi plus Revlimid with R-CHOP improved outcomes with no new or unexpected safety signals.Incyte plans an FDA filing seeking the label expansion of Monjuvi for first-line DLBCL treatment in H1 2026.Incyte (INCY) announced positive top-line results from a late-stage lymphoma study of Monjuvi/Minjuvi (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, ...

The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. 廣州新濟醫藥股份有限公司 Guangzhou Novaken Pharm Co., Ltd. (A joint stock company incorporated in the People's Republic of China with limited liability) WARNI ...

Alumis Inc. (NASDAQ:ALMS) stock is trading higher on Tuesday, with a session volume of 4.33 million compared to the average volume of 1.02 million as per data from Benzinga Pro.Alumis on Tuesday released topline results from its Phase 3 ONWARD1 and ONWARD2 clinical trials of envudeucitinib in patients with moderate-to-severe plaque psoriasis.Plaque psoriasis is the most common form of this chronic autoimmune skin condition, causing thick, red, inflamed patches (plaques) covered with silvery scales due to ra ...

, Inc. (NASDAQ:ARWR) on Tuesday shared interim results from two Phase 1/2a trials of ARO-INHBE and ARO-ALK7, the company’s investigational RNA interference (RNAi) therapeutics for obesity.Preliminary results showed meaningful reductions in multiple key measures, including visceral fat, total fat, and liver fat.What Is ARO-INHBE and ARO-ALK7 Therapy?Unlike current GLP-1 drugs (like Wegovy or Zepbound) that primarily reduce appetite, these candidates aim to change how the body stores and burns fat by silencin ...

Nimbus Therapeutics said on Tuesday it has entered into a multi-year research and licensing agreement with Eli Lilly to develop artificial intelligence-driven new oral treatments for obesity and other... ...