Core Viewpoint - Moderna's development of seasonal vaccines is considered 'risky' due to the FDA's refusal to review its mRNA-based flu vaccine application, reflecting a conflict between the company's mRNA-centric approach and the U.S. government's changing stance on mRNA technology [1] Group 1: Company Challenges - Moderna faces increasing pressure to expand its business as COVID-19 vaccine sales decline [1] - The FDA's decision not to review the flu vaccine application is a significant setback for Moderna's mRNA development efforts [1] - The company has described the FDA's communication as "inconsistent," indicating potential challenges in regulatory interactions [1] Group 2: Industry Context - The situation highlights the broader risks associated with mRNA technology in the current regulatory environment [1] - Analysts suggest that the shifting views of the U.S. government on mRNA technology pose risks for companies like Moderna that are heavily invested in this area [1]

Group 1 - Shopify's stock increased by 10.3% after reporting Q4 revenue that exceeded expectations [1] - Lyft's stock fell by 16.1% due to Q4 revenue falling short of expectations and weak guidance for the first quarter [1] - Mattel's stock dropped by 29.4% as the company projected annual profits below expectations [1] Group 2 - Moderna's stock declined by 9.1% after the FDA rejected its application for the review of an experimental flu vaccine [1] - Kraft Heinz's stock fell by 5.8% as the company announced a pause on its split plan [1] - Kingsoft Cloud's stock rose by 9.7% as Goldman Sachs anticipates benefits from Xiaomi's continued investment in AI [1]

Group 1 - The S&P 500 is projected to achieve a 13% increase in earnings per share for the fourth quarter, marking the 10th consecutive quarter of annual earnings growth and the fifth consecutive quarter of double-digit growth [1] - As of February 6, 59% of S&P 500 companies have reported their fourth quarter results, indicating a strong earnings season [1] - Analysts had initially expected an 8.3% increase in earnings per share before raising expectations, particularly for technology companies, which have been significant contributors to earnings growth in recent quarters [3] Group 2 - Major capital expenditures by Big Tech are influencing the AI trade, with ongoing themes such as artificial intelligence and economic policies continuing to impact market dynamics [4] - Upcoming earnings reports from companies including Coca-Cola, Spotify, Robinhood, Lyft, Ford, Rivian, Moderna, Airbnb, and Coinbase are anticipated to provide further insights into market trends [4]

Market Analysis by covering: Moderna Inc. Read 's Market Analysis on Investing.com ...

The vaccine maker says the Food and Drug Administration has refused to review its application to sell a new seasonal flu vaccine. ...

Group 1: Amazon and BETA Technologies - Amazon has acquired a 5.3% stake in BETA Technologies, leading to a nearly 19% increase in BETA's shares premarket [4][5] Group 2: Moderna - Moderna's shares fell 9% in premarket trading after the FDA refused to file its application for the mRNA-1010 influenza vaccine, citing inadequate trial controls [6][8] - The FDA's refusal was based on the application not reflecting the best-available standard of care during the study, although no specific safety or efficacy concerns were identified [7] - Moderna plans to meet with FDA officials to clarify the next steps but does not anticipate an impact on its 2026 financial guidance [8] Group 3: Estée Lauder and Walmart - Estée Lauder is suing Walmart for selling counterfeit products on its platform, claiming that Walmart facilitated these sales despite not selling the products directly [9][10] - The lawsuit alleges that Walmart allowed the use of Estée Lauder's trademarks in search engines, profiting from counterfeit sales [10]

Employment and Economic Outlook - The employment report is anticipated to show an increase in U.S. job growth despite a sluggish labor market, influenced by tariff uncertainty and tighter immigration enforcement [1][8] - Retail sales have stalled unexpectedly, raising the probability of an interest-rate reduction in April to 35.5% from 32.2% [1][8] - Markets are pricing in the first interest rate cut to occur in June, coinciding with the expected Senate approval of President Trump's Fed chair nominee, Kevin Warsh [2][8] Corporate Earnings and Market Reactions - Cloudflare's shares surged by 14% following a better-than-expected forecast for annual and first-quarter sales [5][8] - Robinhood's shares fell by 7.2% after reporting fourth-quarter revenue below Wall Street expectations [6][8] - Lyft's shares dropped 17% due to a quarterly profit forecast and annual ride volumes that did not meet Wall Street expectations [9][8] Legislative and Regulatory Developments - The U.S. House of Representatives rejected a Republican bid to block challenges to Trump's tariffs, potentially allowing Democrats to reverse tariffs imposed on Canada [7][8] - A Supreme Court ruling on the legality of the tariffs is expected in the coming months [7][9]

班塞尔指出："以FDA已批准的疫苗作为对照进行流感疫苗申报，且该研究方案在启动前已与CBER讨 论并达成一致，对此申请进行全面审评本不应存在争议。"该公司为mRNA-1010提交的上市申请包含两 项后期研究，这些研究均达到了试验的主要目标。 Moderna去年曾表示，其mRNA-1010疫苗比葛兰素史克(GSK.US)已获批的流感疫苗有效性高出26.6%。 该公司称已要求与FDA举行会议，以明确后续路径。 这一进展发生在美国全面修订其长期实施的儿童免疫指导方针，并撤回对包括流感在内的六种传染病常 规疫苗接种建议的一个多月后。Moderna在今年早些接受采访时表示，由于美国官员对疫苗接种的反对 声浪日益高涨，公司不打算投资新的后期疫苗临床试验。当前FDA已批准的流感疫苗包括阿斯利康 (AZN.US)和赛诺菲(SNY.US)生产的产品。 Moderna去年撤回了其流感-新冠联合疫苗的上市申请，以等待其流感疫苗后期试验的有效性数据。目前 该疫苗正在欧盟、加拿大和澳大利亚接受审评，公司预计有望在2026年底或2027年初获得批准。 智通财经APP获悉，Moderna(MRNA.US)周二表示，美国食品药品监督管理局( ...

Core Viewpoint - Moderna shares experienced a 14% decline in Frankfurt following the U.S. FDA's refusal to review the company's influenza vaccine approval application [1] Company Summary - Moderna's stock opened 14% lower in Frankfurt, indicating a significant market reaction to the FDA's decision [1] - The trading volume was low, suggesting limited investor activity during this period [1] Industry Summary - The refusal by the U.S. FDA to review the influenza vaccine application may impact the broader vaccine market and investor sentiment towards vaccine developers [1]

Activist investor Elliott has built a stake in the London Stock Exchange Group and is engaging with the company to drive performance, a person familiar with the matter told Reuters on Wednesday. ...