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Take the Zacks Approach to Beat the Markets: Amneal Pharmaceuticals, Leidos & Vishay Precision in Focus
ZACKS· 2025-10-06 21:11
Key Takeaways Amneal Pharmaceuticals stock jumped 29.9% since its Zacks Rank upgrade on July 25.Leidos shares have advanced 19.8% after a similar Zacks Rank upgrade on July 28.Vishay Precision rose 21.5% following a Zacks Recommendation upgrade to Outperform.Last week, the U.S. stock market delivered a strong performance, with all major indices, including the S&P 500, the tech-heavy Nasdaq Composite and the Dow Jones Industrial Average, advancing by 0.82%, 0.84%, and 0.96%, respectively. Amid a partial gove ...
3 Lesser-Known Healthcare Names With Major Upside in Store
MarketBeat· 2025-10-02 20:19
The global healthcare market is growing rapidly—it is expected to climb at a 6.9% CAGR over the next eight years, reaching more than $22.3 trillion by 2033. Its appeal to investors in the current market environment may also lie in its non-cyclical nature, thanks to resilient demand that is more related to health needs and demographics than to external economic conditions. However, finding healthcare names poised for major growth may be difficult, considering that many of the largest legacy firms in the spac ...
Amneal Pharmaceuticals, Inc. (AMRX) Files BLA for XOLAIR® Biosimilar, Targets Multi-Billion-Dollar Market
Yahoo Finance· 2025-10-02 01:44
We recently compiled a list of the 12 Healthcare Stocks with Insider Buying in 2025. Amneal Pharmaceuticals, Inc. is one of them. Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) continues to strengthen its position in generic, branded, and specialty medicines, marking September 2025 with key regulatory milestones and financial progress. On September 26, AMRX submitted a Biologics License Application (BLA) for a biosimilar to XOLAIR® (omalizumab), targeting a multi-billion-dollar market that includes asthma, c ...
Amneal to Report Third Quarter 2025 Results on October 30, 2025
Globenewswire· 2025-10-01 04:05
BRIDGEWATER, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced that the Company will release its third quarter 2025 financial results on Thursday, October 30, 2025, prior to market open. The Company will host an audio webcast at 8:30 a.m. ET. The financial results and live webcast will be accessible through the Investor Relations section of the Company's website at https://investors.amneal.com ...
Amneal Announces BLA Submission of Biosimilar Candidate to XOLAIR® (omalizumab)
Globenewswire· 2025-09-26 20:00
公司动态与战略 - Amneal Pharmaceuticals宣布向美国FDA提交了其奥马珠单抗生物类似药的生物制品许可申请[1] - 该BLA的提交时间早于预期 预计将在2025年第三季度产生2250万美元的研发里程碑费用 而非此前预期的第四季度[5] - Amneal拥有该产品在美国的独家商业化权利 前提是获得监管批准[5] - 公司高管表示 该产品是未来几年重要的潜在增长催化剂 并有望成为首批进入该市场的奥马珠单抗生物类似药之一[4] 产品与市场机会 - 所提交BLA的产品是XOLAIR(奥马珠单抗)的拟议生物类似药 原研药XOLAIR是诺华公司的注册商标[1] - 奥马珠单抗是一种针对游离IgE的人源化单克隆抗体 适应症包括中重度持续性哮喘、伴有鼻息肉的慢性鼻窦炎、食物过敏和慢性自发性荨麻疹[2] - 根据IQVIA数据 截至2025年7月的12个月内 XOLAIR在美国的年销售额总计约41亿美元[4] - 此次BLA提交标志着公司有机会进入这个规模超过40亿美元的美国市场[1][4] 产品组合与管线 - 对于Amneal而言 该产品是其生物类似药管线的重要组成部分 公司目前已有三款上市生物类似药 并预计从2026年到2027年还将推出五款生物类似药 包括这款奥马珠单抗生物类似药[4] - 对于合作伙伴Kashiv BioSciences而言 此次BLA提交是其不断扩大的生物类似药产品组合中的一个重要里程碑 其已上市产品包括RELEUKO和FYLNETRA[4] - Kashiv BioSciences是一家垂直整合的生物制药公司 拥有多项商业化和后期临床阶段资产[7]
Amneal Receives U.S. FDA Approval for Bimatoprost Ophthalmic Solution, 0.01%
Globenewswire· 2025-09-23 20:00
BRIDGEWATER, N.J., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01% (2.5 mL, 5 mL and 7.5 mL). The product is the generic equivalent of LUMIGAN® (bimatoprost ophthalmic solution) 0.01%, whose design is a trademark of Allergan, Inc., an AbbVie company. Bimatoprost ophthalmic solution 0.01% is a ...
Amneal's generic targeting Jazz Pharma’s Xyrem cleared (AMRX)
Seeking Alpha· 2025-09-11 23:56
公司动态 - 公司宣布其针对睡眠障碍治疗药物Xyrem的仿制药获得美国FDA批准 [2] - 公司通过简化新药申请(ANDA)获得市场准入资格 [2] 产品信息 - 获批仿制药对标爵士制药(JAZZ)的Xyrem睡眠障碍疗法 [2] 行业影响 - 仿制药获批将进入原研药Xyrem对应的睡眠障碍治疗市场 [2]
Amneal Receives U.S. FDA Approval of Sodium Oxybate Oral Solution
Globenewswire· 2025-09-11 20:00
Expands Amneal’s Affordable Medicines portfolio and broadens patient accessBRIDGEWATER, N.J, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of Amneal’s sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA) which references Jazz Pharmaceuticals’ Xyrem®. Amneal had previously been distributing an authorized generic of sodium oxybate oral solution in limited quantities. Sod ...
Amneal Pharmaceuticals: A Large, Diversified Clinical Portfolio That Keeps Growing
Seeking Alpha· 2025-09-11 19:23
作者背景 - 作者Albert Anthony是克罗地亚裔美国商业作家 在投资者平台Seeking Alpha拥有超过1000名粉丝 [1] - 作者在Investing dot com等平台撰稿 并计划于2025年在亚马逊推出关于房地产投资信托基金的专著 [1] - 作者拥有非传统金融背景 曾为多家美国财富500强企业担任IT分析师 并于2021年在金融公司嘉信理财技术支持团队工作 [1] - 作者以数据驱动和流程导向的背景创办了自己的股票研究公司Albert Anthony & Company 并100%远程管理 [1] - 作者毕业于德鲁大学 目前正在企业金融学院的资本市场与证券分析师认证项目中学习 [1] 业务范围与内容 - 作者通过其公司提供基于公开数据的通用市场评论和研究 不提供个性化财务建议或管理客户资金 [1] - 作者的研究内容不涉及非上市公司 小盘股或初创公司首席执行官 [1] - 作者活跃于克罗地亚地区媒体 并在YouTube上运营Albert Anthony频道 讨论房地产投资信托基金话题 [1]
Amylyx, Amneal, And Argenx Hit 52-Week Highs Amid Drug Pipeline Momentum And Strategic Catalysts
RTTNews· 2025-09-11 17:41
生物技术公司股价表现 - 多家生物技术公司股价创52周新高 受临床进展、监管里程碑和战略融资举措推动 [1] - Amylyx Pharmaceuticals、Amneal Pharmaceuticals和argenx SE在2025年9月10日均录得显著涨幅 [1] Amylyx Pharmaceuticals Inc (AMLX) - 股价创52周新高12.25美元 较前期低点2.47美元大幅上涨 [2] - 宣布1.75亿美元公开发行 发行1750万股普通股 每股定价10.00美元 [2][3] - 承销商获30天期权可额外购买262.5万股 [3] - 融资将支持avexitide商业化 launch 该药物是首创GLP-1受体拮抗剂 处于治疗术后低血糖和先天性高胰岛素血症的III期试验 [3] - 资金还将用于研发、一般公司用途和营运资本 [3] - 尽管终止了AMX0035治疗进行性核上性麻痹的ORION项目 但管线仍保持强劲 [4] - 继续推进AMX0035治疗Wolfram综合征、AMX0114治疗ALS以及长效GLP-1受体拮抗剂治疗罕见代谢疾病 [4] Amneal Pharmaceuticals Inc (AMRX) - 股价创52周新高9.97美元 日内交易区间9.77-9.97美元 收盘报9.82美元 较前收盘9.89美元微跌0.71% [4] - 美国批准其利培酮长效注射混悬液 这是Risperdal Consta的仿制药 扩大了中枢神经系统产品组合 [5] - 等待denosumab生物类似药FDA审批 预计2025年底获批 可能带来显著收入流 [6] - 继续推广偏头痛和丛集性头痛药物Brekiya(DHE自动注射器)以及帕金森病药物CREXONT [6] - 与Metsera战略合作开发GLP-1代谢疾病疗法 年底前可能公布早期更新或试验启动 [6] - 自2025年4月7日7.13美元以来 股价已上涨39.8%至9.97美元 [7] argenx SE (ARGX) - 股价创52周新高779.03美元 收盘报762.89美元 较前收盘767.00美元微跌0.54% [7] - ADAPT-SERON试验显示VYVGART在血清阴性全身型重症肌无力(gMG)所有亚型均达到主要终点 具有统计学显著改善 [8] - 将寻求FDA标签扩展 可能大幅扩大药物市场范围和收入潜力 [8] - VYVGART已获批用于gMG、免疫性血小板减少症(ITP)和慢性炎性脱髓鞘性多发性神经病(CIDP) [8][9] - 2025年9月16日将举办ARGX-119研发专题网络研讨会 该药物是MuSK激动剂 用于先天性肌无力综合征和肌萎缩侧索硬化症 [10] - 预计2025年底获得日本和加拿大VYVGART-SC标签扩展决定 2026年获得眼肌型MG和原发性ITP的顶线数据 [10]