BOSTON, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Alvotech (NASDAQ: ALVO) for potential securities law violations. Investors who have lost money in their Alvotech investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/alvo. What is this all about? Shares of Alvotech fell 33% Monday after the company received a complete response letter from the FDA for its biologics license application for AVT ...

U.S. stocks traded mixed toward the end of trading, with the Dow Jones index falling more than 150 points on Monday.The Dow traded down 0.41% to 47,369.42 while the NASDAQ rose 0.54% to 23,853.68. The S&P 500 also rose, gaining, 0.22% to 6,855.42.Check This Out: How To Earn $500 A Month From Pfizer Stock Ahead Of Q3 EarningsLeading and Lagging SectorsConsumer discretionary shares jumped by 1.8% on Monday.In trading on Monday, materials stocks fell by 0.6%.Top HeadlineThe ISM manufacturing PMI declined to 48 ...

U.S. stocks traded mixed toward the end of trading, with the Dow Jones index falling more than 150 points on Monday.The Dow traded down 0.41% to 47,369.42 while the NASDAQ rose 0.54% to 23,853.68. The S&P 500 also rose, gaining, 0.22% to 6,855.42.Check This Out: How To Earn $500 A Month From Pfizer Stock Ahead Of Q3 EarningsLeading and Lagging SectorsConsumer discretionary shares jumped by 1.8% on Monday.In trading on Monday, materials stocks fell by 0.6%.Top HeadlineThe ISM manufacturing PMI declined to 48 ...

Alvotech (NASDAQ:ALVO) stock is trading lower on Monday, with a session volume of 2.32 million compared to the average volume of 395.34 thousand as per data from Benzinga Pro. • ALVO is at important technical levels. See the complete data here.Alvotech is a biotech company specializing in the development and manufacture of biosimilar medicines.A biosimilar is a biological drug that is highly similar to an existing, approved biologic drug.The U.S. Food and Drug Administration (FDA) on Monday issued a complet ...

U.S. stock futures were mixed this morning, with the Nasdaq futures gaining more than 100 points on Monday.Shares of Kimberly-Clark Corporation (NYSE:KMB) fell sharply in pre-market trading after the company announced it will acquire Kenvue in a cash and stock transaction with an enterprise value of approximately $48.7 billion.Kimberly-Clark shares dipped 13.6% to $103.50 in pre-market trading.Here are some other stocks moving lower in pre-market trading.uniQure N.V. (NASDAQ:QURE) shares dipped 65.3% to $23 ...

U.S. stock futures were mixed this morning, with the Nasdaq futures gaining more than 100 points on Monday.Shares of Kimberly-Clark Corporation (NYSE:KMB) fell sharply in pre-market trading after the company announced it will acquire Kenvue in a cash and stock transaction with an enterprise value of approximately $48.7 billion.Kimberly-Clark shares dipped 13.6% to $103.50 in pre-market trading.Here are some other stocks moving lower in pre-market trading.uniQure N.V. (NASDAQ:QURE) shares dipped 65.3% to $23 ...

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 ...

核心观点 - 公司合作伙伴在日本获得三项新生物类似药上市批准 包括AVT03 AVT05和AVT06 其中AVT05是全球主要市场首个获批的golimumab生物类似药 [1] - 此次批准标志着公司在日本市场的进一步扩展 继2024年5月成功推出Stelara®生物类似药后 再次增加三条产品线 [1][5] 产品批准详情 - AVT03（denosumab生物类似药）获批规格为120 mg/1.4 mL小瓶装皮下注射剂 适用于多发性骨髓瘤或实体瘤转移引起的骨病变治疗 [2] - AVT05（golimumab生物类似药）获批规格为50 mg预充式注射器皮下注射剂 适用于对常规治疗反应不足的类风湿关节炎患者 [3] - AVT06（aflibercept生物类似药）获批两种剂型：40 mg/mL预充式注射器溶液和40 mg/mL小瓶套装 均用于眼内注射 适应症包括年龄相关性黄斑变性 视网膜静脉阻塞继发黄斑水肿及病理性近视脉络膜新生血管 [4] 商业合作与市场布局 - 公司与富士药业自2018年11月建立合作伙伴关系 目前在日本已获批四款生物类似药 另有两款在研产品授权 [5] - 公司通过全球商业合作伙伴网络覆盖美国 欧洲 日本 中国 亚洲多国 南美 非洲和中东市场 合作伙伴包括Teva制药 STADA Arzneimittel等多家区域龙头企业 [7] 公司背景与产品管线 - 公司专注于生物类似药的开发和制造 目前披露的研发管线包含八款生物类似药候选产品 涵盖自身免疫性疾病 眼部疾病 骨质疏松 呼吸系统疾病和癌症领域 [7] - 公司采用完全整合模式和广泛内部能力 致力于提供高质量 成本效益优化的生物制剂产品 [7]

公司业绩预告 - Alvotech预计将于下月公布2025年第二季度财报 市场共识预期每股亏损26美分 总营收1亿1540万美元 [1] - 公司过往三个季度均超预期 平均盈利惊喜率达24418% 上一季度惊喜率高达30588% [11][12] 收入构成 - 收入分为产品收入与许可及其他收入两大板块 [2] - 产品收入来自两款已获批生物类似药：Simlandi（Humira仿制药）和Selarsdi（Stelara仿制药） 分别于2024年和2025年Q1在美国上市 [3][4] 研发管线进展 - AVT05（Simponi仿制药）正在美欧监管审查中 预计2025年底获批 [7] - AVT06（Eylea仿制药）在美欧同步审查 预计2025年底前获决定 [8] - AVT03（Prolia/Xgeva仿制药）FDA申请已受理 与Dr Reddy's合作开发 [9] - 与Dr Reddy's新签署协议 共同开发Keytruda的PD-L1抑制剂生物类似药 [10] 市场表现 - 公司股价年内下跌265% 显著跑输行业06%的涨幅 [4] 业绩预测模型 - 当前盈利ESP为0% 最准确预估与市场共识均为每股亏损26美分 [14] - 公司现获Zacks Rank 1评级 [14]