AstraZeneca (AZN) announced that the FDA has accepted its supplemental new drug application (sNDA), seeking expanded use of its blockbuster lung cancer drug, Tagrisso (osimertinib) in EGFR-mutated lung cancer.The sNDA is seeking approval for Tagrisso for the treatment of adult patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) following treatment with chemoradiotherapy (CRT).With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expecte ...

Today, we discuss three must-own stocks as major Wall Street indices reach new highs. The rise in share prices of technology stocks and supportive economic data hinting at potential Federal Reserve policy easing have contributed to investor optimism. So far in 2024, the SPDR S&P 500 ETF Trust (NYSEARCA:SPY), which tracks the S&P 500 index, is up 13%. Similarly, the Invesco QQQ Trust ETF (NYSEARCA:QQQ), which tracks the Nasdaq-100, rose 14% since January, while the SPDR Dow Jones Industrial Average ETF Trust ...

文章核心观点 - 制药公司AstraZeneca计划到2030年将收入翻倍至800亿美元 [1] - 公司有信心实现这一目标,因为拥有大量现有产品和20个即将推出的新药,其中一半用于治疗癌症 [1] - 公司最近在美国临床肿瘤学会年会上发布了多款癌症药物的积极临床试验结果 [2] - 新的细胞疗法和抗体偶联药物有望治愈或将癌症变为慢性病 [2] 公司相关 - 公司2023年收入预计为458亿美元 [1] - 公司第一季度销售增长19%,肿瘤业务增长26%,首次超过50亿美元 [2] 行业相关 - 过去10-15年科学技术进步迅速,癌症治疗有望在不远的将来实现治愈或变为慢性病 [2]

CAR031 study at 9.03-mo median follow up achieves disease control rate (DCR) of 91.3% and objective response rate (ORR) of 56.5% for patients across all dose levels (DLs) and ORR of 75.0% at DL4 ROCKVILLE, Md., June 4, 2024 /PRNewswire/ -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, today announced preliminary safety and efficacy results from its ...

AstraZeneca has quietly delivered market-beating results since 2014. Despite skepticism, the company should be able to repeat this feat over the next 10 years.AstraZeneca (AZN -0.70%), recognized as the world's sixth-largest pharmaceutical entity by market capitalization, made a bold proclamation in May 2014. The company set an ambitious goal of achieving annual revenue exceeding $45 billion by 2023.This target was met with skepticism by Wall Street and dismissed as excessively optimistic. Contrary to these ...

HAMILTON, ON and BOSTON, May 29, 2024 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines, today announced that at a special meeting of its shareholders (the "Shareholders"), held virtually earlier today, the Shareholders voted in favour of the resolution to approve the previously announced plan of arrangement with a wholly-owned subsidiary of AstraZeneca under the Canada Business Cor ...

公司报告与行业动态 - 阿斯利康(AZN)公布了其合作伙伴第一三共(Daiichi Sankyo)的实验性候选药物datopotamab deruxtecan(Dato-DXd)在III期TROPION-Lung01研究中的总生存期(OS)数据，该研究对比了Dato-DXd与多西他赛在局部晚期或转移性非小细胞肺癌(NSCLC)患者中的效果。多西他赛是目前该患者群体的标准化疗方案[1] - 尽管Dato-DXd的OS结果在数值上倾向于该药物，但在III期TROPION-Lung01研究的总体人群中未能达到统计学意义。受此消息影响，阿斯利康股价在5月28日下跌了2.4%[2] - Dato-DXd是一种专门设计的针对TROP2的DXd抗体-药物偶联物，由第一三共发现，并由阿斯利康和第一三共联合开发[3] - 在预先指定的非鳞状NSCLC患者亚组中，与多西他赛相比，使用Dato-DXd治疗观察到了临床上有意义的OS改善[4] - OS是III期TROPION-Lung01研究的双重主要终点之一，该研究评估了Dato-DXd在先前治疗过的NSCLC患者中的效果。另一个共同主要终点是无进展生存期(PFS)[5] - 在2023年10月，阿斯利康报告称，在TROPION-Lung01研究中，与多西他赛相比，使用Dato-DXd治疗在总体NSCLC患者人群中实现了统计学上显著的PFS改善[6] - 在非鳞状NSCLC患者中，与多西他赛相比，使用Dato-DXd治疗也实现了临床上有意义的PFS益处[7] - 截至今年，AZN股价已上涨13.8%，而行业增长为15.9%[7] - 在III期TROPION-Lung01研究中，Dato-DXd显示出良好的安全性，与先前研究中观察到的一致。与多西他赛相比，使用该候选药物导致的剂量减少或因不良事件而中断的情况更少[8] - 此外，未发现新的安全性问题或任何级别的药物相关间质性肺病事件[9] - 阿斯利康和第一三共已根据TROPION-Lung01研究的PFS数据，在美国提交了生物制品许可申请(BLA)，寻求批准Dato-DXd用于晚期非鳞状NSCLC。FDA对BLA的决定预计将在2024年第四季度[10] - 阿斯利康还在单独的正在进行临床研究中，同时评估Dato-DXd在NSCLC治疗的早期阶段中的应用[11] - 目前，阿斯利康还正在美国审查一项申请，寻求批准Dato-DXd用于治疗HR+ HER2-乳腺癌。FDA对此适应症的最终决定预计将在2025年第一季度[12]

文章核心观点 - 两家公司都有未来发展的路线图,但AstraZeneca的计划更加雄心勃勃 [1][2] - Pfizer的2030年战略目标是将收入增加至少450亿美元,主要依靠内部研发和并购等业务发展活动 [3][4][5] - AstraZeneca的目标是到2030年将收入增加至800亿美元,并计划推出至少20种新药,其中12种有望每年带来至少50亿美元的销售额 [6][7][8] - AstraZeneca的发展计划更加注重内部管线的执行,不需要过多的并购等业务发展活动,因此不会产生太多债务 [8][10] - 从投资角度来看,AstraZeneca的股票未来有望持续跑赢Pfizer [11][12][13][14]

Its new strategic roadmap aims to catapult the company forward.AstraZeneca (AZN -2.44%) is embarking on a fresh business plan that will see it grow significantly between now and 2030. If it succeeds, it'll be a company that's even more prominent in the global biopharma sector, and its investors could potentially be wealthier too.But that doesn't make it the right choice for everyone, so it's important to dive into the details of exactly what it's setting out to do. Let's start by putting this plan into cont ...

•  Cellectis announced completion of the additional equity investment of $140M by AstraZeneca •  Cash position of $143 million as of March 31, 20241; cash runway projection into 20262 •  Conference call and webcast scheduled for tomorrow, May 29, 2024 at 8:00AM ET / 2:00PM CET NEW YORK, May 28, 2024 (GLOBE NEWSWIRE) -- Cellectis (the "Company") (NASDAQ:CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, today provided busin ...