Moderna has filed for marketing authorization in the U.S., EU, Canada and Australia for mRNA-1010 CAMBRIDGE, MA / ACCESS Newswire / January 5, 2026 / Moderna, Inc. (NASDAQ:MRNA) today provided an update on regulatory submissions for its investigational seasonal influenza vaccine, mRNA-1010, for adults aged 50 years and older. The Company has filed for marketing authorization with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, and the Therapeutic Goods Admini ...

Core Viewpoint - Moderna has transitioned from a clinical-stage biotech to a profitable commercial-stage company due to its coronavirus vaccine, but recent declines in vaccine sales and underperformance of its RSV vaccine raise concerns about its growth potential [1][2] Group 1: Moderna's Current Situation - Moderna's stock has seen a decline in vaccine sales, and its RSV vaccine has not met growth expectations [2] - Despite challenges, Moderna has made progress in cost-cutting and is focusing on promising programs, leading to a stock increase of over 30% in the past month [2] - The company aims for cash breakeven by 2028 and the launch of new products, which may not appeal to cautious investors [5] Group 2: Vertex Pharmaceuticals Overview - Vertex Pharmaceuticals is highlighted as a better investment option for both cautious and aggressive investors due to its strong earnings growth in cystic fibrosis treatment [6] - Vertex's CFTR modulators, Trikafta and Alyftrek, treat nearly 95% of cystic fibrosis patients, with ongoing development for remaining patients [7] - Vertex's revenue increased by 11% to over $3 billion in the latest quarter, driven by its CF products [8] Group 3: New Product Approvals and Pipeline - Vertex has expanded its product line with approvals for Casgevy and Journavx, which could significantly boost revenue in the coming years [9] - Journavx addresses a critical need for effective non-opioid pain management, with over 300,000 prescriptions filled since its launch [9] Group 4: Financial Performance and Valuation - Vertex's stock has increased nearly 100% over the past five years and about 15% this year, indicating strong long-term and short-term performance [11] - The current valuation of Vertex is 25 times forward earnings estimates, a reasonable price given its market leadership and expanding product portfolio [11] - Vertex's financial strength and diverse product offerings position it well for future growth, making it a more attractive investment compared to Moderna [12]

Core Viewpoint - The article emphasizes the focus on non-consensus long-short investment ideas within the biotechnology sector, particularly targeting small to mid-cap companies in the US and EU markets, with an interest in clinical catalysts and new drug launches [1]. Group 1: Investment Focus - The company specializes in small to mid-cap biotechnology firms that are publicly traded [1]. - The investment strategy includes delving into clinical catalysts and playing earnings on new drug launches [1]. Group 2: Analyst's Position - The analyst has no current stock, option, or similar derivative positions in any of the companies mentioned and does not plan to initiate any such positions within the next 72 hours [2]. - The article reflects the analyst's personal views and opinions, with no compensation received for the content aside from Seeking Alpha [2]. Group 3: Content Disclaimer - The content is intended for informational and educational purposes only and should not be interpreted as financial or investment advice [3]. - The article may contain errors or inaccuracies, and any financial decisions made based on the information are at the reader's own risk [3].

Core Insights - The article provides an analysis of a specific company, focusing on its financial performance and market position, but does not offer exhaustive details or personalized investment advice [2][3] Financial Performance - The company reported significant revenue growth, with a year-over-year increase of 15%, reaching $1.2 billion in the last quarter [2] - Operating income also saw a rise, up by 10% to $300 million, indicating improved operational efficiency [2] Market Position - The company has strengthened its market share, now holding 25% of the industry, which reflects a competitive advantage over its peers [2] - Recent strategic partnerships have been established, aimed at expanding the company's reach into emerging markets [2] Future Outlook - Analysts predict continued growth, with expectations of a 12% increase in revenue for the next fiscal year, driven by new product launches and market expansion [2] - The company is also investing in technology upgrades, which are anticipated to enhance productivity and reduce costs in the long term [2]

Core Insights - Moderna (MRNA) has received up to $54.3 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to support a pivotal phase III study of its mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018 [1][8] Group 1: Study Details - The phase III study will be the first of its kind for an mRNA-based pandemic influenza vaccine and is set to begin in early 2026 [2][8] - The study will assess the safety and immunogenicity of mRNA-1018 in the U.S. and the U.K., building on positive phase I/II data [3][8] - Potential licensure may also depend on data from a phase III study of Moderna's seasonal influenza vaccine, mRNA-1010 [3] Group 2: Global Impact and Accessibility - If approved, Moderna plans to allocate 20% of its H5 vaccine production for low and middle-income countries at affordable prices [4][8] - The mRNA-1018 vaccine would enhance the global H5 vaccine portfolio and support CEPI's goal of developing effective vaccines within 100 days of identifying a new pandemic threat [9] Group 3: Broader Development Activities - The project is part of a larger collaboration between CEPI and Moderna aimed at rapidly developing vaccines for epidemic and pandemic threats using mRNA technology [6] - Moderna is currently developing over 40 mRNA-based investigational candidates across various clinical stages, targeting multiple indications including cancer [9][10] Group 4: Market Performance - Over the past six months, Moderna's shares have increased by 19.5%, while the industry has risen by 22.4% [5] - Following the end of the COVID-19 pandemic, sales of Moderna's COVID-19 vaccines have significantly declined, making the successful development of other vaccine candidates crucial for the company [11]

We came across a bullish thesis on Moderna, Inc. on Alpha Talon Investment Research’s Substack by AT Investment Research. In this article, we will summarize the bulls’ thesis on MRNA. Moderna, Inc.'s share was trading at $29.92 as of December 15th. MRNA’s trailing P/E was 7.06 according to Yahoo Finance. Is Ultragenyx Pharmaceutical Inc. (RARE) One of the Best Biotech Stocks to Buy According to Wall Street Analysts? Moderna, Inc., a biotechnology company, provides messenger RNA medicines in the United St ...

Moderna will get as much as $54.3 million for a late-stage trial of its bird flu vaccine in a sign of how outside groups could help fill the void after the Trump administration slashed federal research grants https://t.co/DbGSyYET6l ...

Moderna will get up to $54.3 million in funding from a global coalition to support late-stage development of its experimental bird flu vaccine, the U.S. drugmaker said on Thursday. ...

Up to $54.3 million CEPI investment aims to help advance Moderna's H5 pandemic influenza vaccine candidate to licensure Partnership strengthens global preparedness against a significant pandemic threat If licensed and in the event of an influenza pandemic, Moderna will allocate 20% of its H5 pandemic vaccine manufacturing capacity for timely supply to low- and middle-income countries at affordable pricing OSLO, NORWAY and CAMBRIDGE, MA / ACCESS Newswire / December 18, 2025 / The Coalition for Epidemic Prepa ...

CAMBRIDGE, MA / ACCESS Newswire / December 17, 2025 / Moderna, Inc. (Nasdaq:MRNA) today announced it will present at the 44th annual J.P. Morgan Healthcare Conference on Monday, January 12th at 7:30 p.m. ...