CAMBRIDGE, MA – The U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Moderna , Inc.’s (NASDAQ:) updated COVID-19 vaccine, Spikevax® (2024-2025 formula), for individuals aged 12 and older. In addition, an Emergency Use Authorization (EUA) has been granted for the vaccine’s use in children from 6 months to 11 years old.

Moderna’s latest vaccine formulation targets the KP.2 variant of SARS-CoV-2, aiming to prevent COVID-19 across all age groups starting from 6 months. Following the FDA’s approval, the company expects the vaccine to be available in pharmacies and care settings across the U.S. shortly.

The approval is grounded on a combination of data including manufacturing, preclinical studies, and previously gathered clinical and real-world evidence which supports the safety and efficacy of Moderna’s mRNA COVID-19 vaccines. The decision to update the vaccine to a monovalent KP.2 composition follows the FDA’s guidance for the 2024-2025 COVID-19 vaccine composition.

Stéphane Bancel, CEO of Moderna, commented on the significance of vaccination amidst the ongoing health risks posed by COVID-19, which led to over 600,000 hospitalizations in the U.S. during the 2023-24 season. He also emphasized the importance of staying current with vaccinations to prevent severe illness.

Moderna’s COVID-19 vaccines have been generally well-tolerated, with the most common adverse events reported being pain at the injection site, headache, fatigue, myalgia, and chills.

The company is also manufacturing an updated vaccine targeting the JN.1 variant, as some countries have recommended a vaccine specific to this variant. Regulatory applications for Moderna’s updated vaccines targeting either the KP.2 or JN.1 variants are under review in other countries, with decisions expected in the coming weeks.

Moderna, a leader in mRNA medicine, has been at the forefront of developing vaccines and therapeutics for various diseases, including one of the earliest and most effective COVID-19 vaccines. Its mRNA platform has been instrumental in the rapid development of medical solutions.

The information in this article is based on a press release statement from Moderna, Inc.

In other recent news, Moderna’s financial performance has been the subject of several analyst revisions. Following a challenging second quarter, Deutsche Bank upgraded Moderna shares from Sell to Hold, citing a potential return to revenue growth and a more balanced risk-reward scenario. RBC Capital, however, downgraded Moderna’s shares from ‘Outperform’ to ‘Sector Perform’, expressing concerns about near-term challenges in the vaccine market. Piper Sandler maintained an Overweight rating on Moderna, despite reducing the price target, due to the company’s lowered sales guidance for the year.

Moderna’s earnings call revealed a net loss and a drop in COVID-19 vaccine sales outside the U.S. in the second quarter of 2024. The company revised its 2024 net product sales outlook to between $3.0 billion and $3.5 billion, attributing this adjustment to various market pressures and potential revenue deferrals. Despite these difficulties, Moderna reported positive Phase III results for its flu and COVID-19 combo vaccine and launched its RSV vaccine, mRESVIA, in the U.S.

These recent developments highlight the dynamic nature of Moderna’s operations amidst a competitive vaccine market. The company’s collaborations, such as the one with Merck for the development of mRNA-4157, a treatment combined with KEYTRUDA for a broad range of cancers, are progressing. Investors should consider these factors when evaluating the company’s prospects.

InvestingPro Insights

As Moderna, Inc. (NASDAQ:MRNA) garners FDA approval for its updated COVID-19 vaccine, Spikevax®, investors and stakeholders are closely monitoring the company’s financial health and market performance. According to InvestingPro data, Moderna currently holds a market capitalization of approximately $31.75 billion. The company’s Price to Earnings (P/E) ratio stands at -5.35, reflecting market sentiment about its future earnings potential. Moreover, the company’s Price to Book (P/B) ratio as of the last twelve months ending Q2 2024 is 2.7, which can offer insights into how the market values the company’s assets relative to its current share price.

Despite the approval of its vaccine, Moderna faces challenges as reflected in its revenue growth metrics. The company has experienced a significant decline in revenue growth of -52.6% over the last twelve months ending Q2 2024. This downturn is further highlighted by the quarterly revenue growth rate of -29.94% for Q2 2024. Additionally, an InvestingPro Tip points out that analysts anticipate a sales decline in the current year, which investors should consider when evaluating the company’s future prospects.

InvestingPro offers more insights into Moderna’s financials and market performance. Currently, there are 11 additional InvestingPro Tips available for Moderna, which can be accessed for more in-depth analysis. These tips include observations on the company’s cash position, profitability expectations, and stock price volatility. For instance, one InvestingPro Tip notes that Moderna holds more cash than debt on its balance sheet, which could be a sign of financial stability amidst the anticipated sales decline.

For a more comprehensive understanding of Moderna’s financial standing and to access the full range of InvestingPro Tips, interested parties can visit https://www.investing.com/pro/MRNA.

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