Novavax (NVAX) is one of the stocks most watched by Zacks.com visitors lately. So, it might be a good idea to review some of the factors that might affect the near-term performance of the stock.Shares of this vaccine maker have returned -21.2% over the past month versus the Zacks S&P 500 composite's +4.5% change. The Zacks Medical - Biomedical and Genetics industry, to which Novavax belongs, has lost 1.5% over this period. Now the key question is: Where could the stock be headed in the near term?While media ...

Let's look beyond this piece of bad news from regulators.Vaccine maker Novavax (NVAX -1.64%) has had a rollercoaster of a year. In May, the company's shares soared after it announced a lucrative agreement with biotech giant Sanofi. It's been mostly downhill for Novavax since then, though that's likely due to some profit taking by investors.However, Novavax's shares recently dropped by about 20% in one day after it announced a clinical setback. The biotech's stock price is still up by more than 100% for the ...

文章核心观点 - 新冠疫苗制造商Novavax公司正在研发一种联合新冠和流感疫苗,这可能会为公司带来可观的经常性收入[1][2][3] - 但Novavax最近遭遇一个重大挫折,其联合疫苗项目被美国FDA临时叫停,公司股价一天内下跌近20%[2][4][5] - 这一临时叫停是由于在临床二期试验中出现一例严重不良事件,即运动神经病,FDA正在调查此事[4][5] - 尽管Novavax表示尚未确定该不良事件与疫苗存在因果关系,但这仍然代表了一定风险,可能会延迟该疫苗的上市[6] - 不过Novavax并非完全依赖该联合疫苗,公司最近还推出了新冠单一疫苗,并计划在年底推出更多管线[7] 公司概况 - Novavax是一家专注于新冠和流感疫苗研发的生物技术公司,在疫情初期其股价曾大涨,但由于进度落后于竞争对手而遭受挫折[1] - 公司正在研发一种联合新冠和流感疫苗,这可能会为公司带来可观的经常性收入,但最近遭遇临时叫停[1][2][3] 行业动态 - 与Novavax类似,竞争对手Moderna也在研发联合新冠和流感疫苗,这个市场有望容纳多家参与者[3] - 美国成人中约有45%会接种流感疫苗,联合疫苗可以一针同时预防新冠和流感,具有较大市场潜力[3]

文章核心观点 - 美国食品药品监管局(FDA)对Novavax公司的实验性COVID-19-流感组合("CIC")疫苗和独立流感疫苗候选药物实施了临床暂停 [1] - 这一临床暂停是由于在一项去年1月在美国境外进行的II期研究中,一名参与者接种CIC疫苗后出现了运动神经病的自发报告 [1] - 这一不良事件发生在研究完成后的上个月,Novavax上周五被告知临床暂停的决定 [1] 临床暂停对Novavax股票的影响 - 这一临床暂停可能会推迟Novavax原定在今年年底前启动CIC和独立流感疫苗III期免疫原性研究的计划 [2] - 尽管管理层不认为其疫苗导致了这一不良事件,但正在与FDA密切合作以成功解决这一问题,并正在加快启动这些疫苗的后期研究 [2] - Novavax确认,上述临床暂停不会影响其目前的COVID-19疫苗 [2] NVAX股票表现 - 临床暂停公告令投资者担忧Novavax的增长前景,公司目前仅有一款上市产品,即蛋白质基COVID-19疫苗,在美国市场的需求一直较低 [3] - 一些投资者还担心临床暂停可能会危及Novavax最近与制药巨头赛诺菲(SNY)签署的数十亿美元交易 [3] - 但今年到目前为止,Novavax股价已上涨111.4%,而行业下跌1.8% [3] 赛诺菲交易为NVAX股票注入新生机 - 从明年开始,赛诺菲将获得共同营销Novavax COVID-19疫苗的全球权利(某些国家除外),并拥有开发和营销Novavax疫苗与其流感疫苗组合的独家许可权 [4] - 作为回报,赛诺菲向Novavax支付了5亿美元的预付款,并将支付最高7亿美元的里程碑付款 [5] - 这笔交易有利于Novavax,帮助其消除了之前关于持续经营能力的警告,并为管理层提供了资金支持正在进行的管线项目 [5] 其他公司的COVID-流感组合疫苗研发 - 除Novavax外,辉瑞(PFE)和Moderna(MRNA)等制药巨头也在开发各自基于mRNA技术的COVID/流感组合疫苗 [6] - Moderna目前在COVID/流感组合疫苗领域领先所有竞争对手,6月份报告了其mRNA-1083疫苗在老年人群中的III期研究取得积极结果 [6][7] - 而辉瑞几个月前报告其mRNA基COVID/流感组合疫苗III期研究未能达到其中一个主要免疫原性目标,目前正在评估改进方案 [7]

文章核心观点 - 该公司是一家专注于提供金融新闻和在线广播的公司,拥有遍布全球主要金融中心的新闻团队 [1][2] - 公司专注于中小市值公司的报道,同时也关注蓝筹股、大宗商品和新兴数字技术等更广泛的投资故事 [2] - 公司采用人工智能等技术辅助内容创作,但所有内容仍由人工编辑和撰写 [3] 公司概况 - 公司拥有15年以上的资本市场报道经验,尤其擅长报道小型资源类公司 [1] - 公司的新闻团队遍布全球主要金融中心,包括伦敦、纽约、多伦多、温哥华、悉尼和珀斯 [2] - 公司报道范围涵盖生物科技、采矿、电池金属、石油天然气、加密货币和新兴电动车技术等领域 [2] 技术应用 - 公司积极采用前沿技术,包括自动化和生成式人工智能工具,以提高内容创作效率 [3] - 但所有内容仍由公司的经验丰富的人工编辑和撰稿人员进行编辑和创作 [3]

Key Takeaways The Food and Drug Administration put clinical holds on Novavax's COVID-19 and flu combination vaccine and its standalone flu shot because of safety concerns. The moves came as one patient who took the combination shot reported nerve damage. The company said it was working with the FDA to get the information necessary to resolve the issue and allow the company to move forward with testing. Novavax (NVAX) shares plummeted nearly 20% Wednesday after the Food and Drug Administration (FDA) stopped ...

A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands. Novavax on Wednesday said the Food and Drug Administration has put a hold on its application for a combination shot targeting Covid and influenza and a standalone flu vaccine, sending the company's shares down sharply. The biotech company's stock fell nearly 20% on Wednesday. The so-called clinical hold is due to a single rep ...

文章核心观点 - 美国食品药品监督管理局(FDA)对Novavax公司的新冠-流感组合疫苗(CIC)和独立流感疫苗候选药物的临床试验申请(IND)采取了临时停止措施[1][2] - 这是由于在一名CIC二期临床试验参与者中出现了一例严重不良事件(SAE)- 运动神经病,该参与者于2023年1月接种了疫苗[1] - Novavax公司表示正在与FDA密切合作,提供必要信息以帮助FDA更好地了解这一观察结果,并尽快解决临床试验停止问题,以便尽快启动三期临床试验[2] - Novavax之前的新冠和流感疫苗试验数据中未发现运动神经病的信号,公司将致力于尽快解决此事,并表示新冠疫苗的IND申请不受此次临床试验停止的影响[2] 公司概况 - Novavax是一家总部位于美国马里兰州盖瑟斯堡的全球性公司,专注于利用重组蛋白、创新纳米颗粒技术和专利的Matrix-M佐剂来开发创新疫苗[3] - 公司的产品组合包括新冠疫苗以及CIC和独立流感疫苗候选药物[3] - Novavax的佐剂还被牛津大学和印度血清研究所用于开发疟疾疫苗R21/Matrix-M[3] 风险提示 - 满足监管机构的各种安全性、有效性和产品特性要求(包括工艺验证和检测验证)存在挑战[4] - 资源约束(包括人力和制造能力)可能影响Novavax公司按计划推进监管途径的能力[4] - 临床试验、制造、分销或出口方面的延迟或挑战[4] - Novavax完全依赖印度血清研究所进行共混和灌装,其运营延迟或中断可能影响客户订单交付[4]

The most recent trading session ended with Novavax (NVAX) standing at $12.91, reflecting a +1.77% shift from the previouse trading day's closing. The stock exceeded the S&P 500, which registered a loss of 0.21% for the day. On the other hand, the Dow registered a loss of 0.14%, and the technology-centric Nasdaq decreased by 0.05%. Shares of the vaccine maker witnessed a gain of 3.17% over the previous month, beating the performance of the Medical sector with its loss of 3.28% and underperforming the S&P 500 ...

GAITHERSBURG, Md., Oct. 9, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the European Commission granted Marketing Authorization for Novavax's updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, for use in individuals aged 12 and older for the prevention of COVID-19 in the European Union (EU). This decision follows the positive opinion from the ...