智通财经APP获悉，周五，葛兰素史克(GSK.US)跌逾5%，报43.10美元。消息面上，瑞银分析师表示， GSK已获得美国食品药品监督管理局(FDA)对其血液癌症药物Blenrep的批准，在一项曾存在不确定性的 决定中取得了积极结果，但这一结果因该药物有限的适应症而略显黯淡。瑞银称，FDA批准Blenrep作 为三线疗法——用于已接受过至少两种先前治疗的成年患者——而不是GSK希望的二线疗法。 此外，根据瑞银的说法，患者在每次用药前都需要进行眼科检查，这将令GSK感到失望。"虽然Blenrep 重返美国市场对GSK来说是一个利好消息，但较小的适应症范围和严格的[风险评估与缓解策略]可能降 低了其商业机会，"分析师称。 ...

此外，根据瑞银的说法，患者在每次用药前都需要进行眼科检查，这将令GSK感到失望。"虽然Blenrep 重返美国市场对GSK来说是一个利好消息，但较小的适应症范围和严格的[风险评估与缓解策略]可能降 低了其商业机会，"分析师称。 周五，葛兰素史克(GSK.US)跌逾5%，报43.10美元。消息面上，瑞银分析师表示，GSK已获得美国食品 药品监督管理局(FDA)对其血液癌症药物Blenrep的批准，在一项曾存在不确定性的决定中取得了积极结 果，但这一结果因该药物有限的适应症而略显黯淡。瑞银称，FDA批准Blenrep作为三线疗法——用于 已接受过至少两种先前治疗的成年患者——而不是GSK希望的二线疗法。 ...

BREAKING: Core CPI Inflation Unexpectedly DipsGSK (GSK) stock crumbled Friday after the Food and Drug Administration granted its blood cancer treatment, Blenrep, a narrower-than-expected approval.The agency signed off on several combinations using Blenrep to treat multiple myeloma patients who've undergone at least three prior lines of therapy.GSK was gunning for a comeback with Blenrep. Blenrep won accelerated approval in 2020. But the drug failed its confirmatory study and GSK pulled it from the market in ...

GSK's London-listed shares fell nearly 2% on Friday after the U.S. Food and Drug Administration approved only one of two treatment combinations with the British firm's blood cancer drug, limiting the ... ...

Core Insights - The FTSE 100 Index has reached an all-time high of £9,578 after rising for four consecutive days, driven by reactions to key earnings and macroeconomic data [1] - The index has increased by over 27% from its lowest level this year, indicating a significant recovery in the market [1] Market Performance - The FTSE 100 Index's rise reflects positive sentiment among traders, influenced by recent earnings reports and macroeconomic indicators [1] - The index's performance showcases a strong rebound, highlighting investor confidence and market resilience [1]

美国监管机构批准了葛兰素史克(GSK.US)的一款血癌药物，该决定将允许这家制药商将药物重新推向 全球最大的药品市场。此前因其有效性问题，该药物于2022年撤市。 英国今年早些时候成为首个批准Blenrep回归市场、用于治疗部分多发性骨髓瘤(一种无法治愈的血癌)患 者的国家。欧洲药品管理局也为该药物亮了绿灯，预计将在今年晚些时候获得正式批准。 葛兰素史克于2022年将Blenrep撤市，因当时其未能证明优于现有疗法。该公司随后研究了该药与其他 药物的联合使用方案，并将其用于疾病更早期的患者。 研究发现，与强生公司销售的一种药物相比，该方案能将死亡风险降低42%。 美国食品药品监督管理局批准葛兰素史克的Blenrep与另外两种药物联合用于治疗复发或对初始治疗无 反应的多发性骨髓瘤患者。此项批准附带一项风险缓解计划，旨在确保药物被正确使用，并简化对用药 患者进行照护的医生之间的协调。 在FDA顾问小组强调了对该药物剂量的担忧(包括减少用药量是否能在降低眼部毒性的同时保持疗效的 问题)后，投资者对其能重新获得美国批准的期望有所减弱。 该决定提升了Blenrep的销售潜力，行业研究预估，获得批准后其销售额最高可达26 ...

Core Insights - The US FDA has approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone for treating adult patients with relapsed or refractory multiple myeloma who have undergone at least two prior lines of therapy [1][14][6] Group 1: Approval and Clinical Data - Blenrep's approval is based on the DREAMM-7 phase III trial, which showed a 51% reduction in the risk of death (HR 0.49) and a tripled median progression-free survival (PFS) of 31.3 months compared to 10.4 months for a daratumumab-based triplet [2][6][10] - The safety profile of the Blenrep combination aligns with the known profiles of the individual agents, indicating manageable side effects [2][6] Group 2: Market Need and Accessibility - There is a significant unmet need for new therapies in multiple myeloma, as nearly all patients experience relapse, and existing treatments often lead to suboptimal outcomes [3][6] - Blenrep is the only anti-BCMA agent accessible in community settings, where approximately 70% of patients receive care, fulfilling a major patient need [3][6] Group 3: Ongoing Development and Future Trials - GSK is advancing the DREAMM clinical program to explore Blenrep's efficacy in earlier lines of treatment, with follow-up data expected in early 2028 [7][6] - DREAMM-10, a phase III trial for newly diagnosed transplant-ineligible patients, was initiated in Q4-2024, with interim efficacy data anticipated in early 2028 [7][12] Group 4: Global Approvals and Future Applications - Blenrep has received approvals in multiple markets, including the European Union, UK, Japan, Canada, Switzerland, and Brazil, with applications under review in other regions, including China [8][6]

Core Insights - The U.S. Food and Drug Administration has approved GSK's blood cancer drug, Blenrep, for use in combination with other treatments, indicating a significant regulatory milestone for the company [1] Company Summary - GSK is set to relaunch Blenrep following its FDA approval, which may enhance its market position in the oncology sector [1] Industry Summary - The approval of Blenrep reflects ongoing advancements in cancer treatment options, highlighting the competitive landscape within the pharmaceutical industry focused on oncology [1]

Wall Street expects a year-over-year decline in earnings on higher revenues when GSK (GSK) reports results for the quarter ended September 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on October 29. On the ...

Core Insights - GSK's experimental drug latozinemab, developed in collaboration with Alector, failed to slow the progression of a rare form of dementia, leading to a significant drop in Alector's stock price by nearly 60% [1] - Alector plans to focus on other experimental therapies for Alzheimer's and Parkinson's diseases, while also announcing substantial layoffs and the resignation of its R&D head [2] Company Developments - Alector's drug aimed at frontotemporal dementia, linked to mutations in the progranulin gene, did not show clinical benefits in a late-stage trial, prompting the company to terminate the study and cut nearly half of its workforce [1][2] - GSK's stock experienced a slight decline of 1.4% in early trading, but later showed a recovery with a 0.59% increase in after-hours trading [2] Financial Implications - Alector reported cash and investments of approximately $291.1 million as of the end of September, sufficient to sustain operations until 2027 [2] - The failed trial represents a setback for GSK's development goals, particularly in the dementia treatment sector, raising concerns among investors about the company's strategic direction to achieve its sales target of £40 billion by 2031 [2]