CAMBRIDGE, MA - Moderna , Inc. (NASDAQ:MRNA) has received approval from the U.S. Food and Drug Administration (FDA) for its mRNA respiratory syncytial virus (RSV) vaccine, mRESVIA, to prevent lower respiratory tract disease in adults aged 60 and over. This vaccine, which employs the same mRNA technology as Moderna's COVID-19 vaccines, is the first of its kind to be approved for RSV and is the second mRNA product approved for the company.
The FDA's decision was based on results from the Phase 3 trial ConquerRSV, which involved around 37,000 participants in 22 countries. The trial demonstrated an efficacy rate of 83.7% against RSV lower respiratory tract disease, with follow-up analysis supporting these findings. Published in The New England Journal of Medicine, the data also indicated continued protection over a median follow-up of 8.6 months without serious safety concerns. Common side effects included injection site pain, fatigue, headache, muscle and joint pain.
Moderna's CEO, Stéphane Bancel, highlighted the significance of mRESVIA's approval, noting its ease of use with pre-filled syringes and its potential impact on public health. RSV is a major cause of respiratory infections, particularly in infants and the elderly, leading to significant hospitalization and mortality rates annually in the U.S.
mRESVIA is expected to be available in the U.S. for the 2024/2025 respiratory virus season. The company has also filed for approval of mRNA-1345, the active ingredient in mRESVIA, in multiple markets worldwide.
Moderna, known for its pioneering work in mRNA medicine, has expanded its vaccine portfolio to address infectious diseases beyond COVID-19. The company's mRNA platform has facilitated the rapid development of vaccines and therapeutics for various diseases, aiming to transform treatment and prevention strategies on a global scale.
This news article is based on a press release statement from Moderna, Inc. and does not contain any promotional content. The information provided is intended for factual reporting on the recent FDA approval of Moderna's new RSV vaccine for older adults.
InvestingPro Insights
Following the FDA's approval of Moderna's mRESVIA vaccine, the company's financial health and stock performance become pivotal metrics for investors. Moderna's market capitalization currently stands at a robust $59.64 billion, reflecting significant investor confidence. Despite challenges, Moderna holds more cash than debt on its balance sheet, an InvestingPro Tip highlighting the company's financial stability in a volatile market.
Investors closely monitoring Moderna's stock will note the company's price movements have been quite volatile, with a remarkable 94.97% price total return over the last six months. This volatility is echoed in the stock's recent performance, which has seen a substantial 37.33% return over the past month.
On the horizon, analysts are adjusting their outlooks, with 11 analysts having revised their earnings projections upwards for the upcoming period. This optimism may be tempered by the anticipation of a sales decline in the current year, a factor that investors should consider. For those seeking to delve deeper into Moderna's financials and stock performance, there are additional InvestingPro Tips available, offering comprehensive insights into the company's prospects.
To access these valuable tips and further enhance your investment strategy, consider subscribing to InvestingPro. Use the coupon code PRONEWS24 to receive an additional 10% off a yearly or biyearly Pro and Pro+ subscription. With InvestingPro, you can unlock a total of 15 InvestingPro Tips for Moderna, each designed to provide a more nuanced understanding of the company's financial health and market potential.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.