Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Jasper To Contact Him Directly To Discuss Their Options If you suffered losses in Jasper between November 30, 2023 and July 3, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a le ...

公司事件概述 - 律师事务所Holzer & Holzer, LLC正在调查MoonLake Immunotherapeutics (NASDAQ: MLTX) 是否遵守了联邦证券法 [1] - 调查背景是MoonLake于2025年9月28日公布了其VELA-1和VELA-2三期项目的结果 [1] - 公司披露在VELA-2研究中，安慰剂组发生的高于预期的并发事件导致研究未能使用复合策略在16周主要终点达到统计学显著性 [1] - 此消息公布后，公司股价出现下跌 [1] 公司临床研究结果 - VELA-2三期项目的16周主要终点未达到统计学显著性 [1] - 研究失败的原因被归咎于安慰剂组中高于预期的并发事件 [1]

Key Takeaways Alvotech H1 2025 product revenues soared 200% YoY to nearly $205M, driven by immunology biosimilars.The company entered ophthalmology with EU approval for Mynzepli, a biosimilar to Regeneron's Eylea.Partnerships with Dr. Reddy's and Advanz expand ALVO into oncology and neurology biosimilars.Alvotech (ALVO) is rapidly scaling its presence in the biosimilar/generic market, thanks to its partnership-driven model. Under this approach, the company focuses on development and manufacturing, while its ...

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Lantheus To Contact Him Directly To Discuss Their Options If you suffered losses in Lantheus between February 26, 2025 and August 5, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP ...

公司及行业 * 公司为Aardvark Therapeutics (NasdaqGS: AARD)，一家位于圣地亚哥的生物技术公司，专注于开发调节进食行为的小分子口服药物[2] * 行业为生物制药，特别是针对肥胖症及相关代谢疾病（如Prader-Willi综合征）的疗法开发[2][3] 核心观点与论据 **1 药物作用机制** * 核心药物ARD-101是一种口服、肠道限制性药物，通过激活肠道味觉受体（非舌部），引发多种肠道肽激素（如GLP-1）释放，进而通过肠-脑轴信号传导抑制饥饿感，而非食欲[2][5] * 该机制与当前主流通过中枢神经系统起作用的肥胖药物（如GLP-1受体激动剂）不同，是以更生理性的方式激活正常的肠-脑轴[5][6] * 药物99%停留在肠道内，作用于肠道内分泌细胞[5] **2 目标疾病与差异化** * 首要适应症为Prader-Willi综合征的食欲亢进，该病症由饥饿驱动，患者饥饿素水平高达正常人的4倍，且会进食非食物物品[9][10] * 公司认为GLP-1药物在Prader-Willi综合征中效果不佳，因其主要抑制食欲（奖励驱动），而该病症的核心问题是病理性饥饿[10][11] * 药物可能也适用于普通肥胖症[2] **3 临床数据（ARD-101）** * 二期研究（n=18，28天治疗期）显示，HQ-CT9评分相对基线降低近50%，部分应答者评分降低高达16点[28][35] * 观察到积极轶事：患者餐盘剩食、因分心忘记进餐时间、焦虑减轻、肠道习惯改善、炎症减少[29][30] * 身体成分数据显示，28天内平均体脂百分比降低1.5%，去脂体重增加2%[31] * 与竞争研究中28天内约2点的典型变化相比，ARD-101的效果（平均降低约8点或更多）显著更强[35] **4 三期试验设计** * 入组标准扩展至13岁及以上患者（二期为17岁及以上），并计划进一步降低年龄限制[43] * 采用第二次基线评估以消除入组报告偏倚，减少安慰剂效应[44] * 每组45名患者，即使假设标准差为6，也有90%的置信度检测到与安慰剂相比4点的HQ-CT差异；公司相信真实效应差异大于6点[45] * 设有中期分析进行样本量重新估计，可选增加患者至最多约130名[46][49] * 顶线数据预计明年读出[42] **5 其他研发管线（ARD-201）** * ARD-201是ARD-101与西格列汀的固定剂量复方，西格列汀可抑制DPP-4酶，延长ARD-101释放的激素半衰期[51] * 在饮食诱导肥胖小鼠模型中，ARD-201导致19%的体重减轻，与替尔泊肽在同一模型中的20.5%减重效果相近[52] * 联合微量替尔泊肽（1/10剂量）可使小鼠体重减少30%[53] * 临床研究计划复制这些观察结果[53] 其他重要内容 **1 剂量选择依据** * 三期试验剂量从二期的200 mg BID提升至800 mg BID，以补偿可能存在的食物稀释效应，且因药物肠道限制性，高剂量仍远低于毒性限值，安全性良好[39] **2 对通路功能的信心** * 公司认为Prader-Willi患者的肠-脑轴通路依然存在且功能正常，临床疗效和轶事证据（如餐盘剩食）支持这一点[24][29] **3 开发计划与时间点** * 关于三期试验中期分析的更新，可能在11月初的肥胖周或第三季度更新中提供[47] * ARD-201中的西格列汀成分预计在2026年仿制药化[51]

Healthcare innovation and biotechnology are standing out right now as areas with a lot of promise for investors. September's rate cut has brightened prospects, while R&D, boosted by AI, is driving new drug discoveries. Health and biotech ETFs and investing could make for a worthwhile consideration as equities uncertainty rises. Amid that interest, investors may want to consider how active investing can outperform passive biotech approaches to life sciences in some key ways. See more: Rising Active ETF TCAF ...

SALT LAKE CITY, Sept. 30, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that it will be participating in a webcast presentation and hosting one-on-one meetings with institutional investors at the Lytham Partners Fall 2025 Investor Conference, taking place virtually on Tuesday, September 30, 2025. Company Webcast The Company presentation w ...

合作与许可协议修订 - 诺瓦瓦克斯与赛诺菲修订了合作与许可协议，将赛诺菲对Matrix-M佐剂的使用许可扩展至其大流行流感候选疫苗项目 [1] - 该修订允许赛诺菲在大流行流感候选疫苗的早期开发至第二阶段临床研究中使用Matrix-M佐剂 [2] - 若赛诺菲进入第三阶段临床开发，双方将就许可费率及财务条款进行协商 [2] 财务条款与里程碑 - 根据原始协议条款，诺瓦瓦克斯有资格因赛诺菲使用其Matrix-M佐剂开发的前四个产品获得高达2亿美元的款项 [3] - 对于此后每个包含Matrix-M的产品，诺瓦瓦克斯有资格获得高达2.1亿美元的里程碑付款，外加所有使用Matrix-M的赛诺菲产品的持续销售分成 [3] 战略合作与政府支持 - 赛诺菲近期获得了美国卫生与公众服务部下属机构的资金，用于支持包括使用Matrix-M佐剂在内的该候选疫苗的早期工作 [1] - 此次修订拓宽了诺瓦瓦克斯与赛诺菲的合作伙伴关系，赛诺菲目前正在探索与Matrix-M的更多合作机会 [3] 技术平台与产品管线 - Matrix-M是诺瓦瓦克斯的专利佐剂，可加入疫苗以刺激更强的免疫反应，目前用于全球已批准的疫苗 [4] - 公司的重组蛋白基纳米颗粒与其Matrix-M佐剂相结合，构成了其不断扩展的研发管线的基础 [4] - 公司的增长战略旨在优化现有合作伙伴关系，并通过研发创新、在传染病等领域的有机产品组合扩张，以及与其他公司建立新的合作伙伴关系，来扩大其成熟技术平台的可及性 [5]

MediWound (MDWD) “announced that it has entered into a definitive securities purchase agreement led by a prominent U.S.-based mutual fund and other healthcare-focused investors for the sale and purchase of 1,734,105 ordinary shares of the Company, par value NIS 0.07 per share, at a purchase price of $17.30 per share, in a registered direct offering. The Company expects to close the offering on or about September 30, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to th ...

VANCOUVER, Washington, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Dear Shareholders, As this pivotal year continues to take shape for CytoDyn Inc. (“CytoDyn” or the “Company”), I am pleased to share the progress we have made in advancing leronlimab as an innovative treatment in oncology. We remain confident that addressing critical unmet needs in this field is the best way to build value while improving the lives of patients. The foundation of our conviction in leronlimab rests on both preclinical and clinical evi ...