CAMBRIDGE, MA - Moderna , Inc. (NASDAQ:MRNA) has received approval from the European Commission (EC) for its mRNA-based respiratory syncytial virus (RSV) vaccine, mRESVIA®, to be used in adults aged 60 and above. This authorization, announced today, follows a Positive Opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) and is valid across all 27 EU member states as well as in Iceland, Liechtenstein, and Norway.
The approval of mRESVIA® marks a significant expansion of mRNA vaccine applications beyond COVID-19 in the European market. According to Moderna's CEO Stéphane Bancel, the vaccine is designed to prevent severe RSV outcomes in older adults and is provided in a pre-filled syringe for easier administration.
RSV is a common respiratory virus that leads to a substantial number of hospitalizations and pneumonia cases, particularly among infants and the elderly. In the EU, around 160,000 hospital admissions annually are attributed to RSV, with the majority of these cases occurring in adults over 65 years of age.
The marketing authorization is supported by data from the ConquerRSV Phase 3 clinical trial, which involved approximately 37,000 participants aged 60 and older across 22 countries. The study, with a median follow-up of 3.7 months, demonstrated a vaccine efficacy of 83.7% against RSV lower respiratory tract disease (LRTD). Extended follow-up showed sustained efficacy over 8.6 months. The most common adverse reactions reported were mild and included pain at the injection site, fatigue, headache, muscle pain, and joint pain.
Earlier in May 2024, the U.S. Food and Drug Administration (FDA) also approved mRESVIA for the same age group under a breakthrough therapy designation, marking it as Moderna's second approved mRNA product. The company has also filed for marketing authorization in multiple other markets worldwide.
Moderna is recognized for its pioneering work in mRNA medicine and has been instrumental in the rapid development of vaccines, including one of the first COVID-19 vaccines. The company's mRNA technology has facilitated the development of treatments and vaccines for various diseases, employing the same lipid nanoparticle delivery system used in its COVID-19 vaccines.
This news is based on a press release statement from Moderna, Inc. and has not been independently verified.
In other recent news, the U.S. Food and Drug Administration (FDA) has approved updated COVID-19 vaccines from Pfizer (NYSE:PFE) and Moderna, designed to combat the prevalent "KP.2" variant. Moderna anticipates the availability of its updated vaccine, Spikevax, across the United States soon. The FDA has also granted emergency use authorization for the use of Spikevax in children from six months to 11 years old.
In the financial arena, Deutsche Bank upgraded Moderna shares from Sell to Hold, citing a potential return to revenue growth. However, RBC Capital downgraded Moderna's shares from 'Outperform' to 'Sector Perform', expressing concerns about near-term challenges in the vaccine market. Meanwhile, 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 challenges, 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 are recent developments that investors should consider when evaluating the company's prospects.
InvestingPro Insights
Following the European Commission's approval of Moderna's RSV vaccine, mRESVIA®, investors are evaluating the company's financial health and market performance to understand its potential future trajectory. According to InvestingPro data, Moderna currently holds a market capitalization of $31.15 billion. Despite the recent positive development, the company's stock has experienced volatility, with a significant price decline over the past three months, amounting to a 50.59% drop in total return.
One key financial metric that stands out is Moderna's Price/Earnings (P/E) ratio. As of the last twelve months leading into Q2 2024, the P/E ratio stands at -5.35, reflecting market skepticism about the company's near-term earnings potential. This is further supported by the InvestingPro Tip that analysts have revised their earnings downwards for the upcoming period, indicating potential concerns about the company's profitability in the near future.
Moreover, despite the challenges, Moderna holds more cash than debt on its balance sheet, which provides some financial stability and flexibility. This is an important InvestingPro Tip as it suggests that the company has a solid liquidity position to manage its short-term obligations and invest in future growth opportunities. Investors can find more detailed analysis and additional InvestingPro Tips by visiting https://www.investing.com/pro/MRNA, where 12 more tips are available to help them make informed decisions.
The InvestingPro data also reveals a substantial revenue decline of -52.6% in the last twelve months as of Q2 2024, which may raise concerns about the company's sales trajectory. However, it's important to note that Moderna's pioneering work in mRNA technology and its ability to secure regulatory approvals for its vaccines could position the company for recovery as it taps into new markets and expands its product offerings.
While the company's gross profit margins have suffered, with a -62.99% margin in the same period, the approval of mRESVIA® could contribute to a turnaround as it begins to generate revenue from this new vaccine. Investors will closely watch how this product's rollout impacts Moderna's financial performance in the coming quarters.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.