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GSK's RSV Vaccine Arexvy Gets EU Nod for Adults Aged 50-59 Years
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GSK plc (GSK - Free Report) has announced the approval of the European Commission (EC) for the expanded use of its respiratory syncytial virus (RSV) vaccine, Arexvy, in adults aged 50-59 years. The vaccine has been approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in patients aged 50-59 years who are at increased risk of the disease.
In the European Union (EU), there are around 65 million adults aged 50-59 years who are at increased risk for RSV disease. Out of these, an estimated 20 million, with an underlying medical condition such as chronic obstructive pulmonary disease, asthma, heart failure and diabetes, will benefit from this vaccine.
With the latest approval, Arexvy becomes the first RSV vaccine approved for high-risk adults aged 50-59 years ahead of this RSV season.
GSK’s Stock Outperforming Industry
Shares of GSK have gained 18.5% so far this year against the industry’s 0.1% decline.
Image Source: Zacks Investment Research
The FDA approved Arexvy for use in adults in June 2024.
Arexvy is currently approved in the United States, Europe, Japan and several other countries for adults aged 60 and above for the prevention of LRTD caused by RSV.
Regulatory applications seeking label expansion of Arexvy for adults aged 50-59 are also under review in Japan and some other countries. Clinical studies on Arexvy for expanded use in adults aged 18-49 are also ongoing with data read-outs expected later in the second half of 2024.
Arexvy Becomes an Important Revenue Driver for GSK
Arexvy was the first RSV vaccine for older adults to be approved anywhere in the world. It had an exceptional launch and generated £1.2 billion in sales in 2023. In the first six months of 2024, the vaccine generated £244 million in sales.
Arexvy’s lukewarm sales in the first half of 2024 are in line with anticipated seasonality patterns. Sales are likely to be much higher in the second half of the year.
However, revised recommendations for RSV vaccinations issued in June 2024 by the U.S. Advisory Committee on Immunization Practices (ACIP) are expected to hurt Arexvy’s sales.
In June, the ACIP recommended the use of Arexvy for all adults aged 75 and above. However, for adults aged 60-74, the ACIP recommended the vaccine only for those who are at increased risk of severe RSV disease. It also postponed a vote for adults aged 50-59. GSK expects Arexvy sales in the 50-59 group to be minimal in 2024 while sales in the 60-74 group will be affected by ACIP’s recommendation.
Other RSV Vaccine Makers in the Market
Pfizer’s (PFE - Free Report) RSV vaccine, Abrysvo, was launched to help protect older adults as well as infants through maternal immunization in the United States as well as in the EU in 2023. Abrysvo recorded sales of $201 million in the first six months of 2024.
PFE is also evaluating Abrysvo in a phase III study for use in adults aged 18-59 years. Pfizer plans to seek approval from the FDA for the expanded use of Abrysvo for adults 18 years and older. However, the company has not yet provided any timeline for the filing.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 5.4%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
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GSK's RSV Vaccine Arexvy Gets EU Nod for Adults Aged 50-59 Years
GSK plc (GSK - Free Report) has announced the approval of the European Commission (EC) for the expanded use of its respiratory syncytial virus (RSV) vaccine, Arexvy, in adults aged 50-59 years. The vaccine has been approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in patients aged 50-59 years who are at increased risk of the disease.
In the European Union (EU), there are around 65 million adults aged 50-59 years who are at increased risk for RSV disease. Out of these, an estimated 20 million, with an underlying medical condition such as chronic obstructive pulmonary disease, asthma, heart failure and diabetes, will benefit from this vaccine.
With the latest approval, Arexvy becomes the first RSV vaccine approved for high-risk adults aged 50-59 years ahead of this RSV season.
GSK’s Stock Outperforming Industry
Shares of GSK have gained 18.5% so far this year against the industry’s 0.1% decline.
Image Source: Zacks Investment Research
The FDA approved Arexvy for use in adults in June 2024.
Arexvy is currently approved in the United States, Europe, Japan and several other countries for adults aged 60 and above for the prevention of LRTD caused by RSV.
Regulatory applications seeking label expansion of Arexvy for adults aged 50-59 are also under review in Japan and some other countries. Clinical studies on Arexvy for expanded use in adults aged 18-49 are also ongoing with data read-outs expected later in the second half of 2024.
Arexvy Becomes an Important Revenue Driver for GSK
Arexvy was the first RSV vaccine for older adults to be approved anywhere in the world. It had an exceptional launch and generated £1.2 billion in sales in 2023. In the first six months of 2024, the vaccine generated £244 million in sales.
Arexvy’s lukewarm sales in the first half of 2024 are in line with anticipated seasonality patterns. Sales are likely to be much higher in the second half of the year.
However, revised recommendations for RSV vaccinations issued in June 2024 by the U.S. Advisory Committee on Immunization Practices (ACIP) are expected to hurt Arexvy’s sales.
In June, the ACIP recommended the use of Arexvy for all adults aged 75 and above. However, for adults aged 60-74, the ACIP recommended the vaccine only for those who are at increased risk of severe RSV disease. It also postponed a vote for adults aged 50-59. GSK expects Arexvy sales in the 50-59 group to be minimal in 2024 while sales in the 60-74 group will be affected by ACIP’s recommendation.
Other RSV Vaccine Makers in the Market
Pfizer’s (PFE - Free Report) RSV vaccine, Abrysvo, was launched to help protect older adults as well as infants through maternal immunization in the United States as well as in the EU in 2023. Abrysvo recorded sales of $201 million in the first six months of 2024.
PFE is also evaluating Abrysvo in a phase III study for use in adults aged 18-59 years. Pfizer plans to seek approval from the FDA for the expanded use of Abrysvo for adults 18 years and older. However, the company has not yet provided any timeline for the filing.
Moderna (MRNA - Free Report) has secured FDA approval for its mRNA-based RSV vaccine, mResvia, this May. This vaccine is a new entrant into the RSV vaccine space. MRNA had already started shipping mResvia doses.
Earlier this month, the EC granted marketing authorization to mRESVIA for use in adults aged 60 years and above.
Moderna is also evaluating its RSV vaccine in early-stage studies for high-risk adults, as well as maternal and pediatric populations.
GSK’s Zacks Rank & a Stock to Consider
GSK currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Illumina, Inc. (ILMN - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 5.4%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.