GSK Seeks FDA Approval For RSV Vaccine In More Adults: Retail Sees No Reason To Shift Their Bullish Stance

GSK plc (GSK) said on Monday that its application for extending the use of its respiratory syncytial virus (RSV) vaccine Arexvy to adults aged 18-49 who are at increased risk of contracting the disease has been accepted by the U.S. Food and Drug Administration (FDA).

The vaccine is currently approved in the U.S. 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. Adults can be at increased risk for RSV disease due to certain comorbidities, immune-compromised status, or advanced age.

A regulatory decision by the FDA on this submission is expected in the first half of 2026.

GSK is continuing to seek expanded indications for its RSV vaccine in other geographies, including in the European Economic Area and Japan, the company said.

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, as per GSK. RSV can exacerbate conditions, including Chronic Obstructive Pulmonary Disease (COPD), asthma, and chronic heart failure, and can lead to severe outcomes, such as pneumonia, hospitalization, and death.

Arexy’s turnover fell 57% in the first quarter (Q1) of 2025 to £78 million ($105 million) due to lower demand. The company pegged the decline in sales within the U.S. partly to a more limited recommendation from the Advisory Committee on Immunization Practices for individuals aged 60 to 74.

On Stocktwits, retail sentiment around GSK stayed unmoved within ‘bullish’ territory over the past 24 hours while message volume remained at ‘high’ levels.

NYSE-listed shares of GSK are up by 13% this year but down by about 1% over the past 12 months.

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