CAMBRIDGE, MA - Moderna , Inc. (NASDAQ:MRNA) has applied for U.S. Food and Drug Administration (FDA) approval for its updated Spikevax vaccine, targeting the SARS-CoV-2 variant JN.1, the company announced today. The submission follows guidance from the FDA and global health authorities to adapt COVID-19 vaccines for the 2024-2025 respiratory illness season.
The FDA's recommendation for an updated monovalent JN.1 composition is in line with the World Health Organization (WHO) and the European Medicines Agency's (EMA) advice. Moderna's CEO, Stéphane Bancel, emphasized the importance of keeping vaccinations current to protect against COVID-19.
Pending regulatory approval, manufacturing of the new Spikevax formula is already in progress, with plans to begin distribution in August, ahead of the upcoming vaccination season. Moderna is also submitting data to international regulators to facilitate the global supply of the vaccine.
The most commonly reported adverse events in trials for the updated Spikevax vaccine included injection site pain, headache, fatigue, myalgia, and chills. Moderna's mRNA platform, which has been instrumental in developing COVID-19 vaccines, is also being utilized to create treatments for other diseases.
Moderna's current COVID-19 vaccine (2023-2024 Formula) has been authorized for emergency use in the U.S. for individuals 6 months through 11 years of age, while the Spikevax vaccine is indicated for those 12 years and older.
The company has outlined the importance of monitoring for allergic reactions, the increased risk of myocarditis and pericarditis, particularly in young males, and the possibility of fainting associated with vaccine administration. Moderna has also acknowledged that while the vaccine is effective, it may not protect all recipients.
The information in this article is based on a press release statement from Moderna, Inc.
In other recent news, Moderna has seen significant developments.
The company's shares have been given an Overweight rating and a $214.00 price target by Piper Sandler. Moderna has also received approval from the U.S. Food and Drug Administration (FDA) for its mRESVIA (mRNA-1345) vaccine, set to be launched this fall. Additionally, RBC Capital Markets raised their price target for Moderna to $160, following the approval of the company's Respiratory Syncytial Virus (RSV) vaccine.
Moderna has also announced anticipated product sales of at least $4.0 billion in 2024. The company is preparing to release Phase III data on its combined Flu+COVID vaccine mRNA-1083 and potential Phase III CMVictory data on mRNA-1647 within the year. Moreover, Moderna and Merck have reported a 49% risk reduction in high-risk melanoma patients from their Phase 2b clinical trial, using a combination of mRNA-4157 (V940) with KEYTRUDA (pembrolizumab).
In collaboration with Pfizer (NYSE:PFE), BioNTech (NASDAQ:BNTX), and Novavax (NASDAQ:NVAX), Moderna has presented promising results for updated COVID-19 vaccines, showing increased efficacy against new strains like KP.2.
Lastly, Moderna received FDA approval for mRESVIA, its mRNA-based vaccine designed to protect adults aged 60 and over from lower respiratory tract disease caused by the RSV, with an efficacy of 83.7% in preventing RSV lower respiratory tract disease.
InvestingPro Insights
As Moderna, Inc. (NASDAQ:MRNA) gears up for the potential approval and distribution of its updated Spikevax vaccine, the company's financial health and market performance provide a backdrop for investors considering the stock. According to InvestingPro data, Moderna holds a market capitalization of $57.86 billion, reflecting its significant presence in the biotechnology industry. Despite challenges, the company has shown notable stock price movements, with an impressive 6-month price total return of 93.48% as of this year.
InvestingPro Tips highlight that Moderna holds more cash than debt on its balance sheet, which may provide the company with a stable financial position to manage upcoming challenges and investments in vaccine development. Additionally, 9 analysts have revised their earnings upwards for the upcoming period, indicating a positive outlook on the company's profitability potential.
However, it's worth noting that analysts anticipate a sales decline in the current year, and the company has not been profitable over the last twelve months. Moreover, Moderna does not pay a dividend to shareholders, which may influence the investment decisions of income-focused investors.
For investors seeking deeper analysis and more tips, including the company's gross profit margins and volatility, InvestingPro offers additional insights. There are 14 more InvestingPro Tips available for Moderna, which can be accessed through the dedicated page for the company at https://www.investing.com/pro/MRNA. Use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, offering valuable information that could help in making informed investment decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.