REYKJAVIK, Iceland, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05, in a prefilled syringe and autoinjector presentations, a biosimilar candidate to Simponi® (golimumab). The CRL noted that certain deficiencie ...

REYKJAVIK, ICELAND (November 2, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05, in a prefilled syringe and autoinjector presentations, a biosimilar candidate to Simponi® (golimumab). The CRL noted that certain deficiencies, which were ...

BERKELEY, Calif., Nov. 02, 2025 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that it will hold a webcast beginning at 8:00 am ET on Monday, November 3, 2025, to report new data from the ANTLER phase 1 clinical trial evaluating vispacabtagene regedleucel (vispa-cel; formerly CB-010), an allogeneic anti-CD19 CAR-T cell therapy, in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NH ...

LUXEMBOURG, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Tenaris S.A. (NYSE and Mexico: TS and EXM Italy: TEN) (“Tenaris”) announced today that pursuant to its USD 1.2 billion Share Buyback Program (the “Program”) announced on May 27, 2025, it has entered into a non-discretionary buyback agreement with a primary financial institution (the “Bank”) for the execution of its second tranche, covering up to the remainder USD 600 million of the Program (excluding customary transaction fees). This second tranche shall start o ...

MHRA response is based on the Phase 3 DRAGON interim analysis results Topline final data expected in Q4 2025 SAN DIEGO, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed to accept a Conditional Marketing Authorization appl ...

SHENZHEN, China, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Fangzhou Inc. (“Fangzhou” or the “Company”) (HKEX: 06086), a leader in AI-driven Internet healthcare solutions, was presented with a Generative AI Service Filing Certificate at the first Guangdong Provincial LLM Filing Conference in Shenzhen. At the event, Dr. Xie Fangmin, Founder, Chairman, and CEO of Fangzhou, remarked: “The successful launch of the ‘XingJie’ Large Language Model (‘XJ LLM’) marks another milestone in Fangzhou’s advancement of AI-driven ch ...

公司对做空报告的回应 - 公司强烈谴责Wolfpack Research近期发布的恶意做空报告，认为该报告包含虚假和诽谤性言论，旨在通过操纵DVLT股票获取经济利益 [1] - 公司计划对Wolfpack Research提起诉讼，以追究其恶意行为责任并维护股东权利 [2] - 公司已聘请Paul Hastings LLP和Dickinson Wright PLLC两家律所就诉讼策略及监管行动提供咨询，正在评估法律权利并计划采取一切可行补救措施 [3] 公司知识产权与技术优势 - 公司的价值根植于强大的知识产权组合，包括70多项美国及国际专利，涵盖AI驱动的数据估值、不可听音频信号技术、区块链代币化框架以及企业数据变现系统 [4] - 知识产权组合带来授权收入机会，并为竞争对手构建了难以逾越的准入壁垒，近期获批专利涉及区块链碳信用代币化、虚拟现实数据整合以及AI驱动的音频追踪系统等 [4] - 公司技术已在数字身份与医疗、声学数据及现实资产代币化等多个行业创造价值 [4] 公司领导层背景 - 首席执行官Nathaniel T Bradley是一位成就斐然的美国发明家和企业家，在移动营销、音频处理、AI及数据变现领域拥有超过二十年经验 [5] - Bradley曾创立AudioEye Inc (NASDAQ: AEYE)和Augme Technologies / Hipcricket，并被评为“安永年度企业家决赛入围者”，因社会影响力荣获爱迪生金奖 [5] - 在Datavault AI领导了AI数据估值、现实资产区块链代币化以及通过ADIO®技术实现的AI音频通信的创新开发工作 [5] 公司业务与技术平台 - Datavault AI居于人工智能驱动数据应用体验、资产估值与变现领域的前沿，其基于云端的平台让声学与数据科学两大部门紧密协作 [8] - 声学部门持有Wisam®、ADIO®和Sumerian®的专利技术，具备业界领先的空间音频与多通道无线高清音频传输基础技术 [8] - 数据科学部门利用高性能计算技术，提供数据感知体验、资产估值及安全变现的综合解决方案，平台服务于体育与娱乐、生物科技、金融科技、医疗健康等多元行业 [8] 近期业务进展与战略合作 - 公司与NYIAX建立战略联盟实现智能合约数据交换，完成对CompuSystems Inc资产的收购以拓展企业事件数据处理能力 [10] - 通过声学科学部门推出WiSA E Endeavour™接收器模块，与Nature's Miracle Holding Inc及Harrison Global Holdings Inc合作面向全球XRP社区推出“The X Club” [10] - 公司宣布成立并筹备推出四个独立数据交易所，包括International Elements Exchange Inc、International NIL Exchange Inc等，着眼于现实资产代币化、NIL权利变现、企业数据市场及政治捐赠透明化领域 [10]

HTVRONT Black Friday sales will kick off on November 1st with exclusive dealsSACRAMENTO, Calif., Nov. 01, 2025 (GLOBE NEWSWIRE) -- As Black Friday approaches, HTVRONT, a global innovator in heat press and crafting technology, is set to launch its largest promotion of 2025, running from November 1st to December 1st across Amazon and its official website. This exciting event features steep discounts on best-selling machines, alongside exclusive chances to win free orders and limited-edition mystery machines, ...

文章核心观点 - 公司发布关于HERA框架协议和公共准备业务的澄清说明，确认了来自欧洲卫生应急准备与响应管理局的75万剂MVA-BN天花/猴痘疫苗订单，该订单将于2026年交付，并与早前美国生物医学高级研究与发展管理局的订单共同为2026年构建15-20亿丹麦克朗的基础准备业务奠定基础 [1][2] 新订单详情 - 欧洲委员会通过HERA下达了75万剂MVA-BN天花/猴痘疫苗的初始订单，将于2026年交付 [2] - 这是公司为2026年获得的第二份订单，第一份是2024年5月宣布的美国BARDA的合同选项 [2] - 公司预期在接下来一年内将获得额外的MVA-BN订单 [2] 财务影响与业务展望 - BARDA和HERA的订单是构建2026年基础准备业务的良好开端，规模预计在15-20亿丹麦克朗，与此前指引一致 [2] - HERA协议的授予不影响2025年的业绩指引 [2] 公司业务定位 - 公司是一家全球疫苗公司，致力于通过创新疫苗改善健康并拯救生命 [3] - 公司是政府加强公共卫生准备的首选天花和猴痘疫苗供应商，并拥有领先的旅行疫苗组合 [3]

GUANGZHOU, China, Nov. 01, 2025 (GLOBE NEWSWIRE) -- EQU Asset Management is enthusiastic to announce its revised commitment to playing a fuller role in the transition towards a lower-carbon economy and to achieving net-zero greenhouse gas emissions. As a leading wealth management and investment firm, we are accelerating our efforts by deploying innovative solutions that help to combat climate change. Making Tangible Progress Towards a Greener Future At EQU Asset Management, ensuring we make tangible progre ...