Shares of Moderna (NASDAQ:MRNA), a biotech leader in mRNA-based therapies and vaccines, jumped after the company announced that it is progressing with regulatory approval applications for its RSV (respiratory syncytial virus) vaccine, named mRNA-1345. The aim is to prevent RSV-linked lung infections and acute respiratory diseases in those aged 60 and above. To this end, they’ve submitted authorization applications to European, Swiss, and Australian drug agencies and started the process for a Biologics License Application with the U.S. FDA.
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This push for regulatory approval is backed by encouraging data from the ConquerRSV study – a trial involving approximately 37,000 adults in 22 countries. The vaccine showed an effectiveness of over 80% in preventing RSV-LRTD as determined by specific symptom criteria. Most side effects reported were mild or moderate, including pain at the injection site and fatigue. An ongoing study is also looking at the vaccine’s effectiveness in children.
The U.S. FDA recognized the significance of mRNA-1345, granting it Breakthrough Therapy Designation in January 2023 and Fast Track designation in August 2021. Furthermore, in Australia, it’s being evaluated under a Priority Pathway. Alongside this, Moderna is working on additional vaccine projects, including next-gen COVID-19 and influenza vaccines, as part of their respiratory disease vaccine pipeline.
Is Moderna Stock a Buy?
Turning to Wall Street, analysts have a Moderate Buy consensus rating on MRNA stock based on six Buys, four Holds, and one Sell assigned in the past three months, as indicated by the graphic above. Furthermore, the average price target of $224.30 per share implies 78.68% upside potential.
