Moderna (MRNA) shares moved firmly higher Wednesday after the drugmaker unveiled positive data from a late stage trial of its developing respiratory syncytial virus treatment.
Moderna, which is using its messenger-RNA technique to develop the treatment, known as mRNA-1345, and said the drug was 83.7% effective in preventing at least two symptoms of the RSV virus in adults over the age of 60. Infections of RSV, which can be fatal in both younger children and older adults, have accelerated in the U.S. and Europe this winter as Covid and flu viruses continue to spread.
Moderna said it hopes to submit mRNA-1345 to the FDA for regulatory approval sometime before June.
Brookline Capital Markets analyst Leah Rush Cann estimates the drug, if approved, could fully enter the market in 2026, with sales potentially rising to $2.12 billion by 2030, based on a 2% market penetration.
"Today's results represent an important step forward in preventing lower respiratory disease due to RSV in adults 60 years of age and older," said CEO Stéphane Bancel. "These data are encouraging, and represent the second demonstration of positive phase 3 trial results from our mRNA infectious disease vaccine platform after, Spikevax, our COVID-19 vaccine."
"Respiratory diseases are a major public health priority given they have a significant health impact and are a leading cause of hospitalization," he added. "For these reasons, in addition to our mRNA-1345 RSV vaccine candidate, we are committed to developing a portfolio of respiratory mRNA vaccines to target the most significant viruses causing respiratory disease, including COVID-19, influenza, and human metapneumovirus."
Moderna shares were marked 7.5% higher in early Wednesday trading to change hands at $206.17 each, a move that would extend the stock's six-month gain to around 26.2%.
The introduction of a new treatment to Moderna's broader product offering could offset investor concern that supply-chain bottlenecks that will defer some sales of the drugmaker's Covid vaccine into next year.
Moderna said in November that it sees sales of its mRNA-1273 coronavirus vaccine in the region of $18 billion to $19 billion for the 2022 year, down from its prior forecast of $21 billion based on signed contracts, amid broader production challenges that will defer between $2 billion and $3 billion in sales until 2023.
The drugmaker will likely publish its fourth quarter earnings on February 23.
Last fall, the group also paid $250 million to exercise an earlier option with with Merck & Co (MRK) to allow the collaboration of its new messenger RNA-based vaccine, known as mRNA-4157, to be developed alongside Merck's blockbuster Keytruda treatment.
Personalized cancer vaccines, the companies said, are designed to prime the immune system so that a patient can generate a tailored antitumor response to their tumor mutation signature to treat their cancer. The new vaccine, Moderna said, is undergoing mid-stage trials with data expected before the end of the year.
