: Moderna stock pops after company makes regulatory submissions in U.S., Europe, Switzerland and Australia for its RSV vaccine

Moderna Inc.’s stock MRNA rose 3% Wednesday, after the company said it has made regulatory submissions in Europe, Switzerland and Australia for its mRNA-1345 vaccine which targets  RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years or older. The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency, Swissmedic in Switzerland, and the Therapeutic Goods Administration in Australia. The company has also initiated the rolling submission process for a Biologics License Application to the U.S. Food and Drug Administration for the licensure of the mRNA-based RSV vaccine. “RSV is a major cause of lower respiratory tract infections in older adults and can cause a significant burden to health systems through hospitalizations and emergency care admissions,” said Moderna CEO Stéphane Bancel in a statement. The applications are based on data from a Phase 3 trial that found the vaccine was 83.7% effective in preventing RSV-LRTD and was well tolerated. It uses the same mRNA technology as used in Moderna’s COVID vaccine, which was the first product it ever won approval for. The stock has fallen 30% in the year to date, while the S&P 500 SPX has gained 16%.

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