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BREAKING: MoonLake Immunotherapeutics Shares Down Over 85%; Investors Should Contact Block & Leviton to Potentially Recover Losses
Globenewswire· 2025-09-29 14:53
BOSTON, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Block & Leviton is investigating MoonLake Immunotherapeutics (Nasdaq: MLTX) for potential securities law violations. Investors who have lost money in their MoonLake Immunotherapeutics investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/mltx. What is this all about? Shares of MoonLake Immunotherapeutics fell more than 85% in pre-market trading on September 29 after the com ...
聚力中央科创区建设,广慈—思南园区打造生物医药转化服务新高地
中国金融信息网· 2025-09-29 14:35
转自:新华财经 以"汇新智・促转化・共筑国际健康创新生态"为主题的第七届健康中国・思南对话9月28日在沪举办,来自政府部门、科研机构、医疗机构、产业主体及投 资领域的代表汇聚一堂,聚焦生物医药创新转化与国际合作重点方向,共同研究谋划产业发展新路径。 上海市黄浦区委书记杲云在致辞中表示,将强化广慈-思南园区的平台功能,构建以数字科技和生命健康为核心的"2+1"现代产业体系。他特别提及世博浦西 片区"中央科创区"规划,称该区域以数字科技、生命健康为核心产业方向,将打造全球创新要素融汇之地,诚邀企业英才扎根发展。 中国工程院院士、瑞金医院院长宁光介绍,瑞金医院联合黄浦区共建广慈—思南园区,推动多领域跨界融合,国产首台套质子治疗装置、开源病理大模型等 标志性成果已成功落地。未来,医院将深化"医产学研企"协同,主动融入黄浦中央科创区建设。 为推动理念落地,本次会议举行了八大发布与签约环节,涵盖生态构建、人才保障、技术创新等关键领域。黄浦区与瑞金医院共同启动了"广慈思南(中港 汇)医学转化创新生态发布仪式";"园区人才企业年金计划"启航,成为了上海市同类政策在黄浦区及国家级园区的首次落地,彰显了引才留才决心;"瑞金 医学 ...
Here’s Why BeOne Medicines Ltd. (ONC) Declined in Q2
Yahoo Finance· 2025-09-29 14:35
Baird Asset Management, which controls Chautauqua Capital Management, a boutique investment firm, released its second quarter 2025 investor letter for the "Baird Chautauqua International and Global Growth Fund". A copy of the letter can be downloaded here. Global equity markets experienced a significant shift during the quarter, moving from notable losses to reaching new highs. Markets fell following the President's announcement of unexpectedly severe tariffs, which raised recession fears. After a brief pa ...
Genmab Makes $8 Billion Bet On Merus With Potential Cancer Breakthrough
Yahoo Finance· 2025-09-29 14:15
Genmab A/S (NASDAQ: GMAB) on Monday agreed to acquire Merus N.V. (NASDAQ: MRUS) with its late-stage asset petosemtamab, which is in Phase 3 development, for $97 per share in an all-cash transaction representing a transaction value of approximately $8 billion. The transaction is anticipated to close by early in the first quarter of 2026. The proposed acquisition of Merus is expected to accelerate Genmab’s shift to a wholly owned model, expanding and diversifying the company’s revenue, driving sustained gro ...
EA downgraded, AppLovin initiated: Wall Street's top analyst calls
Yahoo Finance· 2025-09-29 13:46
The most talked about and market moving research calls around Wall Street are now in one place. Here are today's research calls that investors need to know, as compiled by The Fly.Top 5 Upgrades: Goldman Sachs upgraded Innoviz Technologies (INVZ) to Buy from Neutral with a price target of $2.50, up from $1.50. The firm cites the company's design potential over the next six months and its "inexpensive" valuation for the upgrade.Morgan Stanley upgraded Citizens Financial (CFG) to Overweight from Equal Weight ...
UCB Soars to Record as Rival MoonLake Crashes on Trial Data
Yahoo Finance· 2025-09-29 13:42
Shares in Belgium’s UCB SA soared to a record, while rival MoonLake Immunotherapeutics lost most of its value, after the latter announced late-stage trial data for an experimental skin disease drug that analysts said failed to demonstrate superiority to one of UCB’s most important medicines. UCB shares surged as much as 20%, adding more than €7 billion ($8.2 billion) in market value. MoonLake plunged as much as 89% at the New York open, erasing most of its $4 billion capitalization. Most Read from Bloom ...
BioLineRx (NasdaqCM:BLRX) Update / Briefing Transcript
2025-09-29 13:32
BioLineRx与Hemispherian AS成立合资企业开发GLYCS1电话会议纪要分析 涉及的行业和公司 * 行业为生物制药行业 专注于肿瘤治疗领域 特别是胶质母细胞瘤(GBM)和其他癌症的DNA损伤响应(DDR)靶向治疗[4][6][8] * 涉及公司为BioLineRx(以色列生物制药公司)和Hemispherian AS(挪威私营生物技术公司) 双方成立合资企业开发GLYCS1[2][4][6] 核心观点和论据 关于GLYCS1分子 * GLYCS1是一种首创口服小分子 靶向DNA损伤响应 用于治疗胶质母细胞瘤和其他癌症 具有独特作用机制[6][14] * 作用机制为靶向TET2酶(在DNA去甲基化中起核心作用) 在癌细胞中恢复TET2活性会产生大量单链DNA断裂 进而导致双链DNA断裂 最终杀死癌细胞[14][15] * 临床前数据显示在多个胶质母细胞瘤小鼠模型中完全阻止肿瘤生长(对照组肿瘤大小增加约20倍) 并显著提高生存率[16] * 分子具有出色的血脑屏障穿透能力 采用胶囊制剂 合成方法稳健简单 稳定性优异[16] 关于胶质母细胞瘤(GBM)市场机会 * GBM是最常见、最具侵袭性的原发性脑癌 患者预后极差 诊断后中位生存期仅约12-18个月[9] * 当前标准护理治疗(2005年确立)包括手术切除后放疗联合替莫唑胺化疗 但50%-75%患者不能从替莫唑胺治疗中获益 获益者总生存期仅 modestly增加约2.5个月[10] * 到2030年 美国GBM年发病率预计约18,500例 EU5国家(英法德意西)约13,400例[10] * 对应市场机会:美国新诊断和复发环境约25亿美元 EU5国家约13亿美元 这是一个开放且竞争较少的市场[10] 关于临床开发计划 * 计划2026年第一季度启动1-2A期临床试验[9][17] * 1期部分预计招募最多30名复发性GBM患者 目标建立最大耐受剂量和/或推荐剂量 数据预计2027年上半年获得[17] * 2A期扩展部分计划包括三个患者队列:GLYCS1单药治疗复发性GBM GLYCS1联合标准护理治疗新诊断GBM GLYCS1联合PARP抑制剂治疗其他实体瘤[18] * 研究将由西北大学Lurie综合癌症中心Multani脑肿瘤研究所的Roger Stupp博士和Dita Primdahl博士担任主要研究者[20] 关于知识产权保护 * GLYCS1用于治疗中枢神经系统癌症(如胶质母细胞瘤)的专利已在美国、欧洲和13个国家获得授权 有效期至少到2040年 可能延长最多5年[11] * GLYCS1用于治疗CD8不过表达的癌症(大多数癌症)的专利已在美国、欧洲和其他国家获得授权或待批 有效期至少到2040年 可能延长最多5年[12] * GLYCS1联合PARP抑制剂用于治疗HR熟练癌症(大多数癌症)的国际专利申请待批 如果获得国家阶段专利 有效期至少到2044年 可能延长最多5年[12] 关于联合PARP抑制剂的潜力 * PARP抑制剂仅对HR缺陷癌症有效(仅占所有癌症的6%)[18] * 早期数据显示GLYCS1与PARP抑制剂具有强协同作用 可使HR熟练癌症(占所有恶性肿瘤的94%)对PARP抑制剂敏感化[18] * 作用机制协同:GLYCS1引起单链断裂 PARP抑制剂阻止这些单链断裂的修复[33] 关于合资企业结构和财务安排 * Hemispherian贡献GLYCS1全球权利 BioLineRx负责管理、执行和资助所有合资企业开发活动[19] * 合资企业初始股权:Hemispherian 60% BioLineRx 40%[19] * BioLineRx股权可能逐步增加至最高70%(与持续投资计划并行)[19] * 交易无初始预付款 所有资金严格用于开发[19] * BioLineRx现有现金可支撑至2027年上半年(截至最近财务日期有2800万美元现金) 部分资金将来自合作伙伴Aramid Ltd和Gloria Biosciences的特许权使用费和潜在里程碑付款[20][23] 其他重要内容 监管状态和认定 * GLYCS1已获得美国FDA的IND许可[9] * 已获得FDA和欧洲药品管理局(EMA)的孤儿药认定 伴随加速审评流程和其他财务利益 批准后可能提供额外市场独占权[17] 额外机会 * 合资企业对Hemispherian管道中的其他分子(全部专注于DNA修复)拥有优先选择权 尽管初始重点将是GLYCS1[11][19] * GLYCS5是另一个类似分子 合资企业可选择推进 但目前无计划[36] * GLYCS1在血癌和其他癌症模型中显示抗肿瘤活性[18][33] 制造和能力 * CMC(化学、制造和控制)非常成熟 由知名国际CDMO生产[25] * 有足够药品启动计划中的研究 计划明年进行生产运行以完成研究[25] * 药物非常稳定 CMC无任何问题[25] 关于MGMT状态 * 基于其作用机制 GLYCS1应在所有表达TET2的癌症中起作用 可能适用于任何MGMT状态[26] * 临床前数据显示在体外对替莫唑胺耐药细胞有效[26] 安全性特征 * 毒理学研究表明GLYCS1安全且耐受性良好 直至测试的最高可行剂量[16][31] * 作用机制特异性针对癌细胞 对正常细胞无负面影响[14][31] 公司其他项目 * motixafortide(CXCR4抑制剂)正在由哥伦比亚大学进行2B期临床试验 联合PD-1抑制剂cemiplimab和标准护理化疗用于一线转移性胰腺癌[47] * 研究由Regeneron和BioLineRx平等支持 计划在观察到40%无进展生存事件时进行预设中期分析[47]
Volition Signs Co-Marketing and Services Agreement with Hologic
Prnewswire· 2025-09-29 13:30
Accessibility StatementSkip Navigation HENDERSON, Nev., Sept. 29, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces that it has signed an agreement with Hologic Diagenode ("Hologic") for the co-marketing of Volition's Nu.Q Discover service. The Nu.Q Discover service provides drug developers and scientists with a range of state-of-the-art assays for rapid epigenetic profiling in disease model development, preclinical testing, and ...
Bio-Techne Stock Climbs on Advances in Spatial Biology Solutions
ZACKS· 2025-09-29 13:25
Key Takeaways Bio-Techne unveiled RNAscope and COMET advances in spatial biology for clinical utility workflows.TECH shares climbed 2.7% to $51.85 after the Sept. 26 announcement of these innovations. TECH's presentations at the NSH Convention will highlight RNAscope and COMET's diagnostic potential.Bio-Techne Corporation (TECH) recently announced new advancements in its spatial biology portfolio for the RNAscope ISH technology and the Lunaphore COMET. Research highlights the potential role of these solutio ...
Capricor Therapeutics: A Buy Ahead Of Phase 3 Topline And Clarified Regulatory Pathway
Seeking Alpha· 2025-09-29 13:08
Analyst’s Disclosure:I/we have a beneficial long position in the shares of CAPR either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any in ...