CAMBRIDGE, MA - Moderna , Inc. (NASDAQ:MRNA) has received a favorable review from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for its mRNA-based respiratory syncytial virus (RSV) vaccine, mRESVIA, for adults aged 60 and over. The CHMP's positive opinion is a crucial step towards the vaccine's marketing authorization in the European Union.
RSV is a common respiratory virus leading to significant illness in infants and the elderly. In the EU, it is estimated to result in around 160,000 hospital admissions annually among adults, predominantly affecting those over 65.
The CHMP's recommendation is based on results from the Phase 3 ConquerRSV trial, which involved roughly 37,000 participants across 22 countries. The trial demonstrated a vaccine efficacy of 83.7% against RSV lower respiratory tract disease (LRTD) over a median follow-up of 3.7 months. A subsequent analysis with a median follow-up of 8.6 months showed sustained efficacy.
The most common side effects reported were injection site pain, fatigue, headache, muscle pain, and joint pain. Moderna's CEO, Stéphane Bancel, noted the vaccine's pre-filled syringe design is intended to streamline administration and reduce errors.
mRESVIA utilizes the same lipid nanoparticle delivery system as Moderna's COVID-19 vaccines. It targets the F glycoprotein, a key component in the RSV infection process.
This positive assessment by the EMA follows the U.S. Food and Drug Administration's (FDA) approval of mRESVIA in May 2024. Moderna is also seeking marketing authorization in other global markets.
The anticipated decision by the European Commission on mRESVIA's EU-wide marketing authorization will mark another step in Moderna's expansion of its mRNA vaccine portfolio, which already includes one of the first COVID-19 vaccines. The company continues to explore mRNA technology applications across various diseases, including infectious diseases, cancer, rare disorders, and autoimmune conditions.
The information in this article is based on a press release statement from Moderna, Inc.
In other recent news, Moderna has been making significant strides with its vaccine portfolio. The ACIP's endorsement of a single-lifetime immunization for Respiratory Syncytial Virus (RSV) for certain adults with Moderna's RSV vaccine candidate, mRESVIA, could influence procurement decisions.
Despite mRESVIA showing lower efficacy at approximately 19 months compared to competitors, the pre-filled syringe presentation is expected to be a key factor for healthcare providers. TD Cowen maintains a Hold rating on Moderna shares with a set price target of $75.00.
Analysts from firms like Argus, Jefferies, and Piper Sandler have maintained positive ratings on Moderna shares following the FDA's approval of mRESVIA. Moderna's mRNA-1283 vaccine demonstrated success in its Phase 3 trial, meeting its primary efficacy endpoint.
The company's mRNA-1083 vaccine, which targets both influenza and COVID-19, also achieved primary endpoints in a Phase 3 trial, outperforming standard flu and COVID-19 vaccines in adults aged 50 and above.
Furthermore, Moderna's combined therapy of mRNA-4157 with KEYTRUDA, in collaboration with Merck, has shown a significant reduction in the risk of recurrence or death in high-risk melanoma patients. Lastly, Moderna is preparing to finalize contracts for its RSV vaccine following the ACIP vote, with expectations to start distribution soon after, indicating a continued effort to innovate in the vaccine space.
InvestingPro Insights
As Moderna, Inc. (NASDAQ:MRNA) garners positive attention from the European Medicines Agency for its RSV vaccine, mRESVIA, the company's financial health and stock performance present a mixed picture. According to InvestingPro data, Moderna's market capitalization stands at $46.93 billion, reflecting its significant presence in the biotechnology industry.
Despite a challenging period with a revenue decline of 65.78% over the last twelve months as of Q1 2024, the company maintains a solid financial position with more cash than debt on its balance sheet, an important consideration for investors assessing the company's resilience.
InvestingPro Tips reveal that Moderna's management has been proactively buying back shares, signaling confidence in the company's future prospects. Moreover, Moderna's liquid assets surpass its short-term obligations, indicating a robust liquidity position that can support ongoing research and development efforts. On the flip side, analysts have concerns about the company's profitability, anticipating a sales decline in the current year and noting that Moderna has not been profitable over the last twelve months.
Investors tracking Moderna's performance will note the stock's volatility, with significant price movements in recent weeks, including a 20.9% drop over the last month. However, over a longer-term horizon, Moderna has delivered a high return over the last decade and a strong return over the last five years. For those interested in delving deeper into Moderna's financials and stock analysis, InvestingPro offers additional insights, including 12 more InvestingPro Tips available at https://www.investing.com/pro/MRNA. To access these insights and more, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.