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 ...

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 ...

临床试验结果对比 - MoonLake的sonelokimab在治疗中重度化脓性汗腺炎的三期临床试验中 其关键数据点显示经安慰剂调整后的综合疗效为14% [2] - UCB的Bimzelx在先前公布的试验结果中显示出18%的经安慰剂调整后的疗效优势 [2] - 摩根大通分析师指出sonelokimab在化脓性汗腺炎适应症上的表现“明确地劣于”Bimzelx [3] 公司市场表现 - UCB股价盘中飙升高达20% 市值增加超过70亿欧元（约合82亿美元） [1] - MoonLake股价在纽约市场开盘时暴跌高达89% 使其约40亿美元的市值大部分蒸发 [1] - UCB的市值现已超过440亿欧元 而MoonLake的市值约为4.35亿美元 [6] 产品与市场前景 - Bimzelx已在美国获批治疗银屑病 自2023年底以来UCB股价已上涨约190% [4] - Bimzelx也已获批治疗化脓性汗腺炎 该疾病在2025年上半年贡献了Bimzelx全球净销售额的21% [5] - 根据MoonLake四月的报告 化脓性汗腺炎市场规模预计将从目前的20亿美元增长至2035年的150亿美元 [5]

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]

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 ...

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 ...

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 ...

BREAKING: Futures Climb With Tesla Deliveries, September Payrolls On Tap Genmab (GMAB), on Monday, announced its plan to buy cancer-focused biotech company Merus (MRUS) for about $8 billion. The news sent Merus stock into the stratosphere. Merus is working on a drug called petosemtamab, which can simultaneously block two drivers of cancer. Its most advanced program is in head-and-neck cancer, but Merus is also testing the drug in patients with metastatic colorectal cancer. Petosemtamab could generate $3 bi ...

Climb Bio (NasdaqGM:CLYM) Update / Briefing September 29, 2025 08:00 AM ET Company ParticipantsCarlo Tanzi - Principal & FounderAoife Brennan - President, CEO & Board MemberCraig Gordon - Nephrologist & Co-Director of Evidence ReviewEdgar Charles - Chief Medical OfficerJulian Harrison - Managing DirectorMatt Phipps - Group Head - BiotechnologyConference Call ParticipantsColleen Kusy - Senior Research Analyst - BiotechnologyThomas Smith - Senior MD & Senior Research AnalystLeland Gershell - MD & Senior Biote ...

Larimar Therapeutics, Inc. (LRMR), Monday announced encouraging data from the ongoing long-term open label or OL study, evaluating daily subcutaneous injections of nomlabofusp in participants with Friedreich's ataxia, a rare, progressive, and systemic disease with neurologic deterioration. During the study, participants were initially administered 25 mg of nomlabofusp daily. Later, the dose was increased to 50 mg in the fourth quarter of 2024. The data showed that nomlabofusp increases skin frataxin or FXN ...