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Pfizer (PFE) Gets EU Nod for Somatrogon & Pneumococcal Jab
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Pfizer (PFE - Free Report) and partner OPKO Health (OPK - Free Report) announced that the European Commission has granted marketing authorization to their once-weekly injection, somatrogon for treating pediatric growth hormone deficiency (“GHD”), a rare disease. The medicine will be marketed by the trade name of Ngenla.
Pfizer and OPKO Health’s Ngenla is a next-generation long-acting recombinant human growth hormone, which is now approved in Europe to treat children and adolescents from 3 years old with growth disturbance due to the inadequate secretion of growth hormone, also called somatotropin. At present, these children are treated with daily injections of somatropin. The approval of this new, longer-acting once-weekly option reduces the treatment burden for these patients. The approval of Ngenla was based on data from the phase III study, which evaluated the safety and efficacy of once-weekly Ngenla compared to once-daily Genotropin (somatropin). In the study, Ngenla was found to be non-inferior to Genotropin, as measured by annual height velocity at 12 months
Ngenla is already approved in Japan, Australia and Canada. However, it is not approved in the United States. Earlier this month, Pfizer and OPKO Health announced that the FDA had issued a complete response letter for their biologics license application (“BLA”) for somatrogon for GHD. In September last year, the FDA had delayed its decision on somatrogon’s BLA by three months.
This year so far, Pfizer’s stock has declined 15% compared with a decrease of 5.2% for the industry.
Image Source: Zacks Investment Research
The European Medicines Agency also approved Pfizer’s 20-valent pneumococcal conjugate vaccine candidate, 20vPnC, for adults 18 years of age or older. The vaccine will be marketed in European Union by the trade name of Apexxnar. The vaccine was approved in the United States in June 2021 where it is marketed by the trade name of Prevnar 20. Pfizer has also submitted a supplemental BLA to include data from a phase III study evaluating the co-administration of Prevnar 20 with a seasonal influenza vaccine.
Pfizer is also evaluating the co-administration of Prevnar 20 and Comirnaty’s booster dose in adults aged 65 or older. It had developed Comirnaty, an mRNA-based COVID vaccine, along with its Germany-based partner, BioNTech (BNTX - Free Report) .
Pfizer and BioNTech have successfully developed Comirnaty, which is now approved for emergency/temporary use in several countries worldwide and fully approved in the United States. In 2021, Pfizer/BioNTech manufactured more than 3 billion doses of Comirnaty. The companies expect to manufacture 4 billion doses by the end of 2022.
Prevnar 20/Apexxnar helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia. Prevnar 20/Apexxnar includes all the 13 serotypes contained in Pfizer’s popular 13-valent pneumococcal conjugate vaccine, Prevnar 13 along with seven additional serotypes
A better-ranked stock is GlaxoSmithKline (GSK - Free Report) , carrying a Zacks Rank #2 (Buy).
Glaxo’s stock has risen 28.4% in the past year. Estimates for Glaxo’s 2022 earnings have gone up from $3.25 to $3.30 over the past 60 days.
Glaxo’s earnings performance has been rather strong with the company beating earnings expectations in three of the last four quarters while meeting estimates in one. Glaxo has a four-quarter earnings surprise of 20.52%, on average.
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Pfizer (PFE) Gets EU Nod for Somatrogon & Pneumococcal Jab
Pfizer (PFE - Free Report) and partner OPKO Health (OPK - Free Report) announced that the European Commission has granted marketing authorization to their once-weekly injection, somatrogon for treating pediatric growth hormone deficiency (“GHD”), a rare disease. The medicine will be marketed by the trade name of Ngenla.
Pfizer and OPKO Health’s Ngenla is a next-generation long-acting recombinant human growth hormone, which is now approved in Europe to treat children and adolescents from 3 years old with growth disturbance due to the inadequate secretion of growth hormone, also called somatotropin. At present, these children are treated with daily injections of somatropin. The approval of this new, longer-acting once-weekly option reduces the treatment burden for these patients. The approval of Ngenla was based on data from the phase III study, which evaluated the safety and efficacy of once-weekly Ngenla compared to once-daily Genotropin (somatropin). In the study, Ngenla was found to be non-inferior to Genotropin, as measured by annual height velocity at 12 months
Ngenla is already approved in Japan, Australia and Canada. However, it is not approved in the United States. Earlier this month, Pfizer and OPKO Health announced that the FDA had issued a complete response letter for their biologics license application (“BLA”) for somatrogon for GHD. In September last year, the FDA had delayed its decision on somatrogon’s BLA by three months.
This year so far, Pfizer’s stock has declined 15% compared with a decrease of 5.2% for the industry.
Image Source: Zacks Investment Research
The European Medicines Agency also approved Pfizer’s 20-valent pneumococcal conjugate vaccine candidate, 20vPnC, for adults 18 years of age or older. The vaccine will be marketed in European Union by the trade name of Apexxnar. The vaccine was approved in the United States in June 2021 where it is marketed by the trade name of Prevnar 20. Pfizer has also submitted a supplemental BLA to include data from a phase III study evaluating the co-administration of Prevnar 20 with a seasonal influenza vaccine.
Pfizer is also evaluating the co-administration of Prevnar 20 and Comirnaty’s booster dose in adults aged 65 or older. It had developed Comirnaty, an mRNA-based COVID vaccine, along with its Germany-based partner, BioNTech (BNTX - Free Report) .
Pfizer and BioNTech have successfully developed Comirnaty, which is now approved for emergency/temporary use in several countries worldwide and fully approved in the United States. In 2021, Pfizer/BioNTech manufactured more than 3 billion doses of Comirnaty. The companies expect to manufacture 4 billion doses by the end of 2022.
Prevnar 20/Apexxnar helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia. Prevnar 20/Apexxnar includes all the 13 serotypes contained in Pfizer’s popular 13-valent pneumococcal conjugate vaccine, Prevnar 13 along with seven additional serotypes
Zacks Rank & Stock to Consider
Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A better-ranked stock is GlaxoSmithKline (GSK - Free Report) , carrying a Zacks Rank #2 (Buy).
Glaxo’s stock has risen 28.4% in the past year. Estimates for Glaxo’s 2022 earnings have gone up from $3.25 to $3.30 over the past 60 days.
Glaxo’s earnings performance has been rather strong with the company beating earnings expectations in three of the last four quarters while meeting estimates in one. Glaxo has a four-quarter earnings surprise of 20.52%, on average.