GAITHERSBURG, Md., Nov. 11, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The FDA has cleared the Company to begin enrolling the planned Phase 3 trial following the determination that No ...

The market expects Novavax (NVAX) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended September 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on November 12, 2024, might help the stock move higher if these key numbers are ...

GAITHERSBURG, Md., Nov. 4, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced it will report its third quarter 2024 financial results and operational highlights at 8:30 a.m. Eastern Time (ET) on Tuesday, November 12, 2024. Details of the event and replay are as follows: Conference call details: Date: November 12, 2024 Time: 8:30 a.m. U.S. ET URL to register phone: https://emportal.ink/3Y6irHG Dia ...

Novavax (NVAX) closed the latest trading day at $10.07, indicating a -1.76% change from the previous session's end. The stock fell short of the S&P 500, which registered a gain of 0.16% for the day. At the same time, the Dow lost 0.37%, and the tech-heavy Nasdaq gained 0.78%. Shares of the vaccine maker have depreciated by 18.84% over the course of the past month, underperforming the Medical sector's loss of 4.09% and the S&P 500's gain of 1.67%. Investors will be eagerly watching for the performance of Nov ...

文章核心观点 1. 投资者应该警惕三种可能预示着医疗保健股票即将下跌的迹象 [1] 2. 这些迹象包括: - 在一段高利润或事件驱动的增长期后进行投资 [2][3][4] - 管理层的时间表一再被推迟 [5][6][7] - 公司频繁进入最新最热门的领域 [8][9][10] 根据相关目录分别进行总结 1. 在一段高利润或事件驱动的增长期后进行投资 - 繁荣时期不会一直持续 [2] - 当推动繁荣的趋势开始消退时,市场往往会抛售之前的赢家股票 [2] - 以Teladoc和辉瑞为例,它们在疫情期间获得了大量需求,收入大幅增长,但随后市场饱和,增长难以持续 [2][3][4] - 投资者应关注公司的长期前景,而不是短期业绩驱动因素 [4] 2. 管理层的时间表一再被推迟 - 在医疗行业,由于需要与政府机构、保险公司和医院等缓慢运转的实体打交道,延迟是常见和不可避免的 [5] - 但如果时间表一再被推迟,即使管理层保证情况正在好转,这可能是股票价值面临高风险的信号 [5][6][7] - 以Novavax疫苗推出延迟为例,反复的推迟损害了投资者的信任 [6][7] 3. 公司频繁进入最新最热门的领域 - 公司进入新的热门领域是正常的,但如果一家生物制药公司频繁推出新的管线项目,追随每个新的药物开发趋势,股价可能会下跌 [8][9][10] - 因为在公司的核心领域进行研发活动,成功开发新药的可能性最高 [8][9][10] - 如果一家专注于干性皮肤的公司突然宣布进入完全不相关的领域,如过度日间嗜睡,股东可能会遭受损失 [10] - 药物开发已经很具挑战性,如果公司进一步复杂化任务,将其扩展到明显超出核心能力的领域,风险会更高 [10]

NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Novavax, Inc. (“Novavax” or “the Company”) (NASDAQ: NVAX). Investors who purchased Novavax securities are encouraged to obtain additional information and assist the investigation by visiting the firm’s site: bgandg.com/NVAX. Investigation Details On October 16, 2024, Novavax issued a press release “announc[ing] that the U.S. Food and Drug Adminis ...

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]