mRNA vaccine company Moderna (Nasdaq:MRNA) plans on submitting for regulatory approval for its investigational RSV mRNA-1345 vaccine after it met primary efficacy endpoints in the Phase 3 ConquerRSV study (NCT05127434). The RSV data are “a clear positive for MRNA” and represent a good omen for upcoming mRNA Phase 3 influenza data, noted UBS in a…
Moderna launches pivotal trial for mRNA RSV vaccine
The Data and Safety Monitoring Board for Moderna’s (NASDAQ:MRNA) respiratory syncytial virus (RSV) vaccine program has backed the launch of a Phase 3 clinical study of the mRNA-1345 vaccine candidate. The study will focus on adults 60 years and older. RSV leads to approximately 177,000 hospitalizations and 14,000 deaths among adults aged 65 years or…
Moderna wins FDA fast track designation for RSV vaccine
COVID-19 vaccine pioneer Moderna (NSDQ:MRNA) is aiming to develop one of the first mRNA-based vaccines against respiratory syncytial virus (RSV). Now, the FDA has granted fast track designation for mRNA-1345, an experimental single-dose mRNA RSV vaccine in adults 60 and older. Pfizer (NYSE:PFE), Johnson & Johnson (NYSE:JNJ), GlaxoSmithKline (LON:GSK), Novavax (NSDQ:NVAX) and Bavarian Nordic (CPH:BAVA)…