Moderna Inc (NASDAQ: MRNA )股价在周二盘后交易中大幅下跌，此前该公司表示美国食品药品监督管理局(FDA)拒绝审查其流感疫苗mRNA- 1010。 在公告发布后，Moderna股价最多下跌7%，至约39美元。 CBER批评Moderna将其疫苗与标准流感疫苗进行对比测试，认为这不能反映"最佳可用护理标准"。Moderna表示，该机构并未指出疫苗存在 任何具体的安全性或有效性问题。 Moderna表示，此举与该机构此前的指导不一致，并已要求与FDA会面以进一步推进。该公司提到了CBER负责人Vinay Prasad的评论——他 支持美国卫生部长Robert F. Kennedy Jr.对加强疫苗监管的呼吁。 Moderna还对FDA的理由提出异议，称该机构之前的指导并不要求临床试验必须使用最先进的可比治疗作为对照。 Moderna曾在2025年中表示，mRNA-1010疫苗在三期临床试验中达到了所有试验目标。该公司将这款疫苗定位为同时针对流感和COVID-19 的组合型流感疫苗。 该公司表示，FDA生物制品评估和研究中心(CBER)已通知Moderna，由于缺乏"充分且良好控制"的研究， ...

Group 1 - The company announced that the agency would not review its application due to insufficient testing in the study for the shot [1]

Economic Data - The US economy added 130,000 jobs in January, significantly exceeding expectations of 65,000 jobs added for the month [1][5] - The unemployment rate decreased slightly to 4.3% from 4.4% [1][6] - Revisions to 2025 payrolls showed a decrease in job growth to 181,000 from a previously reported 584,000, marking the weakest annual job growth outside of a recession since 2003 [2][6] Market Reactions - The tech-heavy Nasdaq Composite rose approximately 0.9%, while the Dow Jones Industrial Average increased by 0.6% (280 points), and the S&P 500 gained 0.7% [1] - The positive January jobs data has led to increased bets on Federal Reserve rate cuts, with over 40% of market participants expecting the Fed to hold rates steady through June [4] Corporate Earnings - McDonald's is set to report earnings after the market close, while Kraft Heinz announced a pause in its spin-off plans, indicating that its challenges are manageable [5][11] - Kraft Heinz plans to invest $600 million in marketing, sales, research and development, and pricing to accelerate its return to profitable growth [11][12] - Cisco is expected to report quarterly results, competing with Nvidia in the AI networking chip market [5]

Moderna said on Tuesday the U.S. Food and Drug Administration will not review its approval application for its influenza vaccine. ...

Core Viewpoint - The FDA's refusal to review Moderna's application for its experimental flu shot, mRNA-1010, reflects a tightening of vaccine regulations influenced by the Trump administration, despite no identified safety or efficacy issues with the vaccine [1][2][4]. Group 1: FDA's Decision and Moderna's Response - The FDA's decision is inconsistent with prior feedback received by Moderna before the application submission and phase three trials [2]. - Moderna has requested a meeting with the FDA to clarify the path forward regarding the application [2]. - The FDA objected to the study design of the clinical trial, which was previously approved, without citing specific safety or efficacy concerns [2][4]. Group 2: Clinical Trial and Regulatory Context - Moderna's flu shot demonstrated positive phase three data last year, achieving all trial goals, and is considered crucial for developing a combination vaccine for influenza and Covid-19 [3]. - The FDA criticized Moderna's choice to compare its vaccine to a standard approved flu shot, stating it did not meet the definition of an "adequate and well-controlled" trial [5]. - Moderna disputes the FDA's reasoning, asserting that existing FDA rules do not mandate the use of the most advanced vaccine as a comparator in clinical studies [5]. Group 3: Future Expectations and Leadership Comments - Moderna anticipates that the earliest approval for its flu shot could occur in late 2026 or late 2027, pending regulatory reviews in multiple regions [6]. - The CEO of Moderna expressed that the FDA's decision does not align with the goal of enhancing U.S. leadership in innovative medicine development [6].

Core Viewpoint - The U.S. FDA has issued a Refusal-to-File letter for Moderna's investigational influenza vaccine mRNA-1010, indicating that it will not initiate a review of the biologics license application despite prior consultations suggesting otherwise [1] Group 1: FDA Decision - The FDA's Center for Biologics Evaluation and Research (CBER) notified the company of its decision not to review the BLA for mRNA-1010 [1] - Moderna had utilized a Priority Review Voucher to expedite the review process for the application [1] Group 2: International Submissions - mRNA-1010 has been submitted and accepted for review in the European Union, Canada, and Australia [1] Group 3: Financial Guidance - The company does not anticipate any impact on its financial guidance for 2026 as a result of the FDA's decision [1]

Core Viewpoint - The company announced that the agency would not review its application due to insufficient testing in the study for the shot [1] Group 1 - The agency's decision is based on the inadequacy of the study testing the shot [1]

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Moderna, Inc. (NASDAQ:MRNA) is one of the stocks in focus on Jim Cramer’s game plan. Cramer finished his game plan with the stock, as he commented: Finally, Friday, we’re going to hear from Moderna, one of the hottest stocks in the market this year, as people are buzzing about their personal cancer vaccines. All I can say is I hope they happen because you know what? We’ve been expecting these for, well, how about since the time it came public seven years ago? Photo by Ian Hutchinson on Unsplash Modern ...