GSK (GSK) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The earnings report, which is expected to be released on July 30, might help the stock move higher if these key numbers are better than expectations. On the ...

截至目前，已有近70家英国企业在上海临港落户，涵盖医药、金融、高端制造等多个行业。 在全球贸易环境面临重塑的背景下，中国（上海）自由贸易试验区临港新片区正将目光投向英国。 2025临港新片区全球投资促进系列活动首站近日在英国伦敦举行，此次活动旨在推动中英两国在高端制 造、跨境金融与科技创新等领域的深度合作，吸引了英国工商界、投资机构以及中资机构的广泛参与。 此次活动由临港新片区管理委员会联合英国中国商会、中银集团投资有限公司共同主办，中国银行伦敦 分行承办。在全球贸易保护主义有所抬头的当下，这场聚焦"制度型开放"与"互利合作"的推介会，被视 为临港对外招商战略的重要一环。 政策红利成核心吸引力 "临港新片区不是简单的自贸区扩展，而是国家在制度型开放方面的'试验田'。"临港新片区常务副主任 杨正伟在会上表示。 近年来，该片区通过实施"五自由一便利"的政策体系——即投资、贸易、资金、人员、数据自由流动及 运输便利，已逐步建立起与国际经贸规则接轨的治理机制。 据介绍，临港目前正在加速形成集成电路、智能汽车、生物医药等世界级产业集群，吸引了包括特斯 拉、波音、GSK等头部企业入驻。已有近70家英国企业在临港落户，涵盖 ...

Core Viewpoint - GSK's Blenrep combination therapy has been voted against by the FDA's Oncologic Drugs Advisory Committee (ODAC) due to an unfavorable benefit/risk profile, indicating that the risks currently outweigh the benefits for treating relapsed or refractory multiple myeloma [1][8]. GSK's Stock Performance - Following the ODAC announcement, GSK's shares fell by 4.7% [2]. - Year-to-date, GSK's shares have increased by 7.8%, contrasting with a 0.6% decline in the industry [6]. Regulatory Context - The ODAC's opinion is significant as the FDA typically considers it in their final decision, which is expected on July 23 [3][8]. - The Blenrep combination therapy has already been approved in the UK and Japan but faces regulatory challenges in the United States [8][11]. - Regulatory applications for the Blenrep combination are under review in the EU and other countries [9]. Clinical Study Background - The biologics license application (BLA) for the Blenrep combination was based on data from the III DREAMM-7 and DREAMM-8 studies, which met their primary endpoints of progression-free survival (PFS) [7]. - However, Blenrep was previously withdrawn from the U.S. market after failing to meet the primary endpoint in the phase III DREAMM-3 study [10].

葛兰素史克（GSK）股价下跌5.3%，原因是其药物Blenrep未能获得美国食品药品监督管理局（FDA） 顾问委员会的支持。 ...

Regulatory Approval - GSK's blood cancer drug approval is in doubt after failing to secure backing from a US regulatory panel [1] Pharmaceutical Industry - The outcome potentially impacts GSK's market position in the blood cancer drug sector [1]

Core Insights - The treatment landscape for primary biliary cholangitis (PBC) has significantly evolved with the recent approvals of Gilead's Livdelzi (seladelpar) and Ipsen's Iqirvo (elafibranor), marking progress in disease management [1] - Pruritus remains a significant unmet need for PBC patients, with many suffering from moderate to severe symptoms that impact their quality of life [2] Treatment Developments - GSK's linerixibat, an ileal bile acid transporter (IBAT) inhibitor, has had its New Drug Application accepted by the FDA for treating cholestatic pruritus in PBC patients, with a target action date of March 24, 2026 [3] - Gastroenterologists express a high likelihood of incorporating linerixibat into treatment if approved, noting its potential for significant symptom reduction despite concerns over side effects like abdominal pain and diarrhea [3] Market Analysis - Spherix Global Insights' Market Dynamix™ service provides analysis on markets expected to undergo significant changes in the next three to five years, focusing on market size, treatment approaches, unmet needs, and expert opinions on pipeline agents [4] - The service aims to track emerging developments in the PBC treatment landscape and pipeline, highlighting the ongoing demand for effective therapies targeting pruritus [3][4]

Core Insights - GSK's RSV vaccine, Arexvy, has received FDA acceptance for expanded use in high-risk adults under 50, with a final decision expected in the first half of 2026 [1][2] - Arexvy is currently approved for individuals aged 60 and older, and for high-risk individuals aged 50-59, and if approved for the younger demographic, it will be the third FDA-approved RSV vaccine for this age group [2][9] - GSK's stock has performed well, gaining 13% year-to-date compared to a 1% decline in the industry [4] Regulatory Developments - A similar regulatory filing for Arexvy was accepted by the EMA, with approval anticipated early next year [3] - The filing is backed by late-stage study data demonstrating Arexvy's safety profile consistent with previous studies [2][8] Sales Performance - Arexvy's sales declined by 51% year-over-year to £590 million (approximately $755 million) in full-year 2024, primarily due to narrower vaccination recommendations from the U.S. Advisory Committee on Immunization Practices (ACIP) [6][8] - The ACIP recommended Arexvy for adults aged 75 and older, but limited vaccination for those aged 60-74 to individuals at increased risk, reducing the eligible population [7][8] Competitive Landscape - GSK's competitive position has weakened as Pfizer and Moderna have gained broader regulatory approvals for their RSV vaccines, covering high-risk individuals aged 18-74 [9] - The CDC has updated guidelines to recommend vaccination for high-risk adults aged 50-59, a group for which Arexvy is already approved, improving the outlook for the upcoming RSV season [10] - All three vaccine-makers, GSK, Pfizer, and Moderna, are on relatively equal footing due to the absence of CDC guidance for high-risk adults under 50, with pending regulatory decisions likely to influence market dynamics [11]

智通财经7月14日电，葛兰素史克表示，已向美国FDA提交申请，将其呼吸道合胞病毒（RSV）疫苗 Arexvy的使用范围扩大到18岁至49岁、患病风险较高的成年人。 ...

Group 1 - The core point of the article is that GlaxoSmithKline has submitted an application to the U.S. Food and Drug Administration to expand the use of its respiratory syncytial virus (RSV) vaccine Arexvy to adults under 50 who are at high risk of illness [1] Group 2 - The application aims to broaden the vaccine's target demographic, potentially increasing its market reach and addressing a significant health concern among vulnerable populations [1]

Core Insights - GSK's Specialty Medicines segment is a significant contributor to its sales, accounting for nearly 40% of total revenue and expected to exceed 50% by 2031 [6] Sales Growth - The Specialty Medicines unit has experienced a 17% sales increase in Q1 2025, driven by successful launches in Oncology and long-acting HIV medicines [2][10] - Key products such as Nucala and Dovato are major revenue drivers, alongside new long-acting HIV treatments like Cabenuva and Apretude, and oncology drugs Jemperli and Ojjaara [3] Research and Development - GSK is increasing R&D investments in long-acting and specialty medicines across various therapeutic areas, including Respiratory, Immunology & Inflammation, Oncology, and HIV [4] - The approval of Blujepa for uncomplicated urinary tract infections and Nucala for chronic obstructive pulmonary disease (COPD) supports the growth trajectory [4][10] Regulatory Approvals - Regulatory applications for Blenrep combinations for multiple myeloma and depemokimab for chronic rhinosinusitis and asthma are under review, with FDA decisions expected in 2025 [5] Competitive Landscape - GSK faces significant competition in the Specialty Medicines segment from major pharmaceutical companies such as AstraZeneca, Merck, and Pfizer [7][8] Stock Performance and Valuation - GSK's stock has increased by 16.3% year-to-date, outperforming the industry average of 0.3% [9] - The company's shares are trading at a forward price/earnings ratio of 8.34, which is lower than the industry average of 14.93 and below its 5-year mean of 10.21 [12] Earnings Estimates - The Zacks Consensus Estimate for GSK's earnings per share has risen from $4.38 to $4.41 for 2025, while the estimate for 2026 has slightly declined [14]