GSK Seeks FDA Approval for Expanded Use of RSV Vaccine Arexvy

GlaxoSmithKline ( (GB:GSK) ) just unveiled an announcement.

GSK has announced that the US FDA has accepted its application to expand the use of its RSV vaccine, Arexvy, to adults aged 18-49 who are at increased risk of severe RSV infection. This submission is backed by positive Phase IIIb trial data demonstrating the vaccine’s immune response and safety in this demographic. The FDA’s decision is expected in the first half of 2026. This expansion could significantly impact GSK’s market positioning by broadening its vaccine’s target demographic, potentially increasing its market share and providing enhanced protection against RSV for millions of at-risk adults.

The most recent analyst rating on (GB:GSK) stock is a Buy with a £2610.00 price target. To see the full list of analyst forecasts on GlaxoSmithKline stock, see the GB:GSK Stock Forecast page.

Spark’s Take on GB:GSK Stock

According to Spark, TipRanks’ AI Analyst, GB:GSK is a Outperform.

GlaxoSmithKline’s stock is supported by strong financial performance and a positive strategic outlook, bolstered by effective shareholder value initiatives. Challenges such as high debt levels and mixed technical signals temper the overall score.

To see Spark’s full report on GB:GSK stock, click here.

More about GlaxoSmithKline

GSK is a global biopharma company focused on uniting science, technology, and talent to combat diseases. It is known for its development of vaccines, including the RSV vaccine, which is approved in various countries for preventing lower respiratory tract disease caused by RSV in older adults and those at increased risk.

Average Trading Volume: 9,369,107

Technical Sentiment Signal: Hold

Current Market Cap: £56.93B

Find detailed analytics on GSK stock on TipRanks’ Stock Analysis page.