We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
PFE Gets FDA Nod for Expanded Use of RSV Vaccine Abrysvo
Read MoreHide Full Article
Pfizer Inc. (PFE - Free Report) announced that the FDA has granted approval for the expanded use of its respiratory syncytial virus (RSV) vaccine, Abrysvo, in adults aged 18-59 years. The vaccine has been approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in patients aged 18-59 years who are at increased risk of the disease.
Following the latest FDA nod, Abrysvo has become the first and only RSV vaccine approved for adults who are younger than 50 years.
Abrysvo is currently approved for the prevention of RSV-associated LRTD in older adults (aged 60 years and above) and in infants through maternal immunization.
Year to date, shares of Pfizer have inched up 1% compared with the industry’s growth of 19%.
Image Source: Zacks Investment Research
More Updates on PFE's Abrysvo
The latest FDA approval was based on data from the phase III MONeT study, which evaluated the safety, tolerability and immunogenicity of Abrysvo in adults at risk of RSV-associated disease owing to certain chronic medical conditions.
In the study, the immune response generated by Abrysvo was non-inferior to the responses seen in adults aged 60 or older, where vaccine efficacy is already demonstrated.
Abrysvo recorded sales of $201 million in the first six months of 2024. The approval for expanded use in adults aged 18 to 59 should boost vaccine sales going forward.
Other RSV Vaccine Makers in the Market
GSK plc’s (GSK - Free Report) RSV vaccine, Arexvy, is approved for the prevention of LRTD caused by RSV in older adults aged more than 60 years. This was the first RSV vaccine for older adults to be approved anywhere in the world.
GSK’s Arexvy was approved for high-risk adults aged 50-59 years in the United States and the European Union in June and August 2024, respectively. In the first six months of 2024, the vaccine generated £244 million in sales.
GSK is also conducting clinical studies on Arexvy for expanded use in adults aged 18-49 years.
Moderna (MRNA - Free Report) secured FDA approval for its mRNA-based RSV vaccine, mResvia, this May to prevent RSV-LRTD in older adults aged 60 years and above. This vaccine is a new entrant in the RSV vaccine space. MRNA had already started shipping mResvia doses.
The European Commission granted marketing authorization to mRESVIA for use in adults aged 60 years and above in August.
Moderna is also evaluating its RSV vaccine in early-stage studies for high-risk adults, as well as maternal and pediatric populations.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have moved up from $2.38 to $2.48. Earnings per share estimates for 2025 have improved from $7.31 to $7.44. Year to date, shares of KRYS have rallied 41.3%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
PFE Gets FDA Nod for Expanded Use of RSV Vaccine Abrysvo
Pfizer Inc. (PFE - Free Report) announced that the FDA has granted approval for the expanded use of its respiratory syncytial virus (RSV) vaccine, Abrysvo, in adults aged 18-59 years. The vaccine has been approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in patients aged 18-59 years who are at increased risk of the disease.
Following the latest FDA nod, Abrysvo has become the first and only RSV vaccine approved for adults who are younger than 50 years.
Abrysvo is currently approved for the prevention of RSV-associated LRTD in older adults (aged 60 years and above) and in infants through maternal immunization.
Year to date, shares of Pfizer have inched up 1% compared with the industry’s growth of 19%.
Image Source: Zacks Investment Research
More Updates on PFE's Abrysvo
The latest FDA approval was based on data from the phase III MONeT study, which evaluated the safety, tolerability and immunogenicity of Abrysvo in adults at risk of RSV-associated disease owing to certain chronic medical conditions.
In the study, the immune response generated by Abrysvo was non-inferior to the responses seen in adults aged 60 or older, where vaccine efficacy is already demonstrated.
Abrysvo recorded sales of $201 million in the first six months of 2024. The approval for expanded use in adults aged 18 to 59 should boost vaccine sales going forward.
Other RSV Vaccine Makers in the Market
GSK plc’s (GSK - Free Report) RSV vaccine, Arexvy, is approved for the prevention of LRTD caused by RSV in older adults aged more than 60 years. This was the first RSV vaccine for older adults to be approved anywhere in the world.
GSK’s Arexvy was approved for high-risk adults aged 50-59 years in the United States and the European Union in June and August 2024, respectively. In the first six months of 2024, the vaccine generated £244 million in sales.
GSK is also conducting clinical studies on Arexvy for expanded use in adults aged 18-49 years.
Moderna (MRNA - Free Report) secured FDA approval for its mRNA-based RSV vaccine, mResvia, this May to prevent RSV-LRTD in older adults aged 60 years and above. This vaccine is a new entrant in the RSV vaccine space. MRNA had already started shipping mResvia doses.
The European Commission granted marketing authorization to mRESVIA for use in adults aged 60 years and above in August.
Moderna is also evaluating its RSV vaccine in early-stage studies for high-risk adults, as well as maternal and pediatric populations.
PFE's Zacks Rank & Stock to Consider
Pfizer currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Krystal Biotech, Inc. (KRYS - 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 Krystal Biotech’s 2024 earnings per share have moved up from $2.38 to $2.48. Earnings per share estimates for 2025 have improved from $7.31 to $7.44. Year to date, shares of KRYS have rallied 41.3%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.