CAMBRIDGE, MA - Moderna , Inc. (NASDAQ:MRNA) has received authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its updated COVID-19 vaccine, Spikevax® JN.1, targeting the JN.1 variant, the company announced today. This vaccine is designed to combat the currently dominant JN.1 group of subvariants in the UK.
The MHRA's approval enables the distribution of the vaccine to high-risk groups through the National Health Service (NHS) as part of the upcoming autumn vaccination program. Additionally, for the first time, the vaccine will be available for private purchase in the UK at pharmacies, occupational health providers, and private healthcare companies.
Darius Hughes, UK General Manager of Moderna, stated that the updated vaccine plays a crucial role in protecting those most vulnerable to severe illness and hospitalization from COVID-19, while also alleviating pressure on the NHS.
This decision follows recommendations from the World Health Organization's Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC), which advised updating vaccines to target the JN.1 family of Omicron subvariants for the 2024/25 vaccination campaign.
Moderna has been at the forefront of mRNA medicine, developing vaccines and therapeutics for various diseases, including one of the first COVID-19 vaccines. The company emphasizes its commitment to transforming the treatment and prevention of diseases through mRNA technology.
The press release includes forward-looking statements regarding the availability and efficacy of the updated vaccine as the virus evolves. However, Moderna cautions that these statements are subject to risks and uncertainties that could cause actual results to differ from expectations.
This news article is based on a press release statement from Moderna, Inc. and does not include any speculative information. The facts presented are intended to inform readers about the recent development in COVID-19 vaccine availability in the UK.
In other recent news, Moderna's updated Spikevax COVID-19 vaccine formulation, targeting the JN.1 variant, has received approval from the Taiwan Food & Drug Administration, following recent approvals by the Japanese Ministry of Health, Labour and Welfare, and the US FDA. Brookline Capital Markets maintained a Buy rating on Moderna with a price target of $310.00. The COVID-19 vaccines are projected to generate $2.7 billion in sales for Moderna in 2024, contributing significantly to the company's revenue.
Moderna's mRNA-based vaccine, mRESVIA, received FDA approval, but current evidence suggests it may not perform as well compared to competing products. HSBC upgraded Moderna's stock from Reduce to Hold due to an unexpected dip in COVID-19 vaccine revenue. The European Commission approved Moderna's mRESVIA for adults aged 60 and above, but the company revised its 2024 net product sales outlook to between $3.0 billion and $3.5 billion.
Piper Sandler maintained its Overweight rating for Moderna, projecting sales for SpikeVax to reach $2.85 billion. The company reported encouraging Phase III data for its mRNA-1010 seasonal flu vaccine and mRNA-1283 next-generation COVID vaccine. Moderna also received approval from the European Commission for its mRESVIA, for adults aged 60 and above. These are recent developments for Moderna.
InvestingPro Insights
As Moderna, Inc. (NASDAQ:MRNA) secures approval for its updated COVID-19 vaccine in the UK, financial metrics and analyst insights provide a broader context for the company's current market position. With a market capitalization of $29.75 billion, Moderna's financial health is reflected in its balance sheet, holding more cash than debt, which is a positive sign for potential investors and stakeholders. This is particularly noteworthy as the company navigates the evolving landscape of the pandemic and vaccine demand.
Despite facing challenges such as anticipated sales decline for the current year and weak gross profit margins, with a gross profit margin of -62.99% over the last twelve months as of Q2 2024, the company's stock price has shown resilience over the long term. An InvestingPro Tip highlights Moderna's strong return over the last five years, underscoring the company's growth potential. Additionally, the Relative Strength Index (RSI) suggests that Moderna's stock is currently in oversold territory, which could indicate a potential turning point for interested investors.
With 12 additional InvestingPro Tips available, including insights on earnings revisions and profitability expectations, stakeholders can dive deeper into Moderna's financial outlook by visiting https://www.investing.com/pro/MRNA.
Moderna's commitment to mRNA technology and its role in addressing public health challenges remains a focal point for both its scientific and business endeavors, as reflected in its continuous innovation and adaptation to new COVID-19 variants.
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