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Biotech Stocks Facing FDA Decision In June 2024

GSK plc
GSK plc

GSK has sought FDA approval to extend the indication of its adjuvanted respiratory syncytial virus (RSV) vaccine Arexvy to adults aged 50-59 who are at increased risk for RSV disease and a decision is due on June 7, 2024.

If approved, Arexvy would be the first vaccine available to help protect this population. It received FDA approval to treat adults aged 60 and over for the prevention of lower respiratory tract disease (LRTD) caused by RSV last May.

Arexvy, the world’s first vaccine for RSV, contributed £1.2 billion of sales in its first year on the market in 2023.

GSK closed Wednesday’s trading at $44.28, up 0.09%.