The company is looking forward to a decision from the regulator on the application in the first half of 2026.

U.K.-based biopharmaceutical company GSK plc (GSK) said on Friday that the European Medicines Agency (EMA) has accepted its regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to include adults aged 18 years or above.

Arexvy is already approved in the European Economic Area for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, and for those aged 50-59 years who are at increased risk for RSV disease due to underlying medical conditions.

RSV is a common contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year, GSK said. The virus can aggravate conditions such as asthma and chronic heart failure, leading to hospitalisation and death.

The company is looking forward to a decision from the regulator on the application in the first half of 2026.

Meanwhile, the firm is continuing to seek an expansion for the treatment scope of its RSV vaccine in geographies including the U.S. and Japan.

Arexvy brought in 78 million British pounds ($106.08 million) for GSK in the first quarter of 2025, down 57% from the corresponding period of 2024, following a drop in sales in the U.S., and accounting for just 1% of its overall turnover in the period.

On Stocktwits, retail sentiment around GSK remained unmoved within ‘extremely bearish’ territory over the past 24 hours while message volume remained unchanged at ‘normal’ levels.

GSK's Sentiment Meter and Message Volume as of 12:15 p.m. ET on Jun 13, 2025 | Source: Stocktwits

NYSE-listed shares of GSK are down by 3% as of Friday noon. The stock is up approximately 22% this year and has increased by about 1% over the past 12 months.

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