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

US regulators have refused to review Moderna’s novel mRNA flu vaccine, dealing a major blow to the company as it seeks more products beyond its Covid shot https://t.co/ei4gwXITGs ...

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 ...

Core Viewpoint - Moderna has signed a Memorandum of Understanding with the Mexican Government and local pharmaceutical companies to enhance Mexico's health sovereignty and establish a local mRNA manufacturing ecosystem [1] Group 1: Strategic Agreement - The agreement is a five-year strategic partnership aimed at strengthening health security in Mexico [1] - It includes the supply of Moderna's respiratory vaccine portfolio to Mexico [1] - Technology transfer will be provided to Laboratorios Liomont for the domestic manufacturing of Moderna's COVID-19 vaccine, mRNA-1273 [1] Group 2: Health Sovereignty and Manufacturing Resilience - The initiative supports "Plan Mexico," which focuses on building a local mRNA ecosystem [1] - The collaboration aims to create a reliable in-country supply of respiratory vaccines [1] - Laboratorios Liomont is noted for its state-of-the-art manufacturing facilities, which will be utilized for this purpose [1]

Core Viewpoint - Moderna, Inc. (NASDAQ:MRNA) is highlighted as a promising healthcare stock under $50, with a Hold rating from Morgan Stanley and a price target of $28.00 [1] Group 1: Strategic Collaboration - Moderna announced a strategic collaboration with Recordati on January 29 to advance its investigational therapeutic mRNA-3927 for propionic acidemia through clinical development and commercialization [1][2] - Under the agreement, Moderna will receive an upfront payment of $50 million and up to an additional $110 million in near-term development and regulatory milestones, along with commercial milestones and tiered royalties on net sales [2] - mRNA-3927 is currently in a registrational study that has reached target enrollment, with a potential data readout anticipated in 2026 [2] Group 2: Company Overview - Moderna is a biotech company focused on developing transformative medicines based on messenger RNA (mRNA) [3] - The company's operations are segmented into the United States, Europe, and Rest of World, with a diverse product pipeline that includes prophylactic vaccines, cancer vaccines, and various therapeutic modalities [3]