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FDA Accepts Merck's (MRK) BLA for 21-Valent Pneumococcal Jab
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Merck (MRK - Free Report) announced that the FDA accepted the biologics license application (BLA), seeking approval for the use of V116, its 21-valent pneumococcal conjugate vaccine (PCV) candidate, in adults.
The BLA has been granted priority review by the FDA. A filing designated as a priority review reduces the review period by four months. A final decision is expected by Jun 17, 2024.
Per Merck, V116 targets serotypes that account for 83% of all invasive pneumococcal disease in older adults in the United States, including eight serotypes not covered by currently licensed vaccines. If approved, V116 would become the first PCV specifically designed for adults.
The BLA is mainly supported by positive data from the pivotal phase III STRIDE-3 study, which evaluated V116 against pneumococcal 20-valent conjugate vaccine (or PCV20) in adults who had not previously received a pneumococcal vaccine. The FDA filing is supported by data from other multiple late-stage studies, namely STRIDE-4, STRIDE-5 and STRIDE-6, which evaluated V116 in vaccine-naïve and previously vaccinated individuals. All these studies achieved their key immunogenicity and safety endpoints.
Merck’s shares have lost 4.0% year to date against the industry’s 5.0% growth.
Image Source: Zacks Investment Research
Pneumococcal infection is caused by the bacterium Streptococcus pneumonia. While there are more than 100 different types of S. pneumoniae serotypes, only a few of these are responsible for the majority of pneumococcal infections.
Merck currently markets Vaxneuvance, a 15-valent PCV, which is approved in the United States for use in individuals aged six weeks and older. In the first nine months of 2023, Merck recorded $488 million from Vaxneuvance sales.
PCV20 vaccine is the current standard of care in the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. This vaccine is marketed by Pfizer (PFE - Free Report) under the brand name Prevnar-20. The Pfizer vaccine is currently approved in the United States for use in individuals aged six weeks and older.
Pfizer also markets another pneumococcal vaccine, Prevnar 13, which contains 13 S. pneumoniae serotypes and is approved for use in individuals aged six weeks and older. In the first nine months of 2023, Pfizer recorded $4.8 billion from combined sales of Prevnar 13 and Prevnar 20.
Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Galapagos (GLPG - Free Report) and Novo Nordisk (NVO - Free Report) . While Galapagos sports a Zacks Rank #1 (Strong Buy) at present, Novo Nordisk carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, Galapagos’ estimates for 2023 have improved from a loss of $1.96 per share to 79 cents. During the same period, loss estimates per share for 2024 have narrowed from $3.22 to $1.68. Galapagos’ shares have lost 10.8% in the year-to-date period.
Galapagos’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 91.97%. In the last reported quarter, Galapagos’ earnings beat estimates by 140.78%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.57 to $2.61. During the same period, the earnings estimates for 2024 have risen from $2.99 to $3.10. Shares of NVO have surged 47.8% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.
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FDA Accepts Merck's (MRK) BLA for 21-Valent Pneumococcal Jab
Merck (MRK - Free Report) announced that the FDA accepted the biologics license application (BLA), seeking approval for the use of V116, its 21-valent pneumococcal conjugate vaccine (PCV) candidate, in adults.
The BLA has been granted priority review by the FDA. A filing designated as a priority review reduces the review period by four months. A final decision is expected by Jun 17, 2024.
Per Merck, V116 targets serotypes that account for 83% of all invasive pneumococcal disease in older adults in the United States, including eight serotypes not covered by currently licensed vaccines. If approved, V116 would become the first PCV specifically designed for adults.
The BLA is mainly supported by positive data from the pivotal phase III STRIDE-3 study, which evaluated V116 against pneumococcal 20-valent conjugate vaccine (or PCV20) in adults who had not previously received a pneumococcal vaccine. The FDA filing is supported by data from other multiple late-stage studies, namely STRIDE-4, STRIDE-5 and STRIDE-6, which evaluated V116 in vaccine-naïve and previously vaccinated individuals. All these studies achieved their key immunogenicity and safety endpoints.
Merck’s shares have lost 4.0% year to date against the industry’s 5.0% growth.
Image Source: Zacks Investment Research
Pneumococcal infection is caused by the bacterium Streptococcus pneumonia. While there are more than 100 different types of S. pneumoniae serotypes, only a few of these are responsible for the majority of pneumococcal infections.
Merck currently markets Vaxneuvance, a 15-valent PCV, which is approved in the United States for use in individuals aged six weeks and older. In the first nine months of 2023, Merck recorded $488 million from Vaxneuvance sales.
PCV20 vaccine is the current standard of care in the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. This vaccine is marketed by Pfizer (PFE - Free Report) under the brand name Prevnar-20. The Pfizer vaccine is currently approved in the United States for use in individuals aged six weeks and older.
Pfizer also markets another pneumococcal vaccine, Prevnar 13, which contains 13 S. pneumoniae serotypes and is approved for use in individuals aged six weeks and older. In the first nine months of 2023, Pfizer recorded $4.8 billion from combined sales of Prevnar 13 and Prevnar 20.
Merck & Co., Inc. Price
Merck & Co., Inc. price | Merck & Co., Inc. Quote
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Galapagos (GLPG - Free Report) and Novo Nordisk (NVO - Free Report) . While Galapagos sports a Zacks Rank #1 (Strong Buy) at present, Novo Nordisk carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, Galapagos’ estimates for 2023 have improved from a loss of $1.96 per share to 79 cents. During the same period, loss estimates per share for 2024 have narrowed from $3.22 to $1.68. Galapagos’ shares have lost 10.8% in the year-to-date period.
Galapagos’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 91.97%. In the last reported quarter, Galapagos’ earnings beat estimates by 140.78%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.57 to $2.61. During the same period, the earnings estimates for 2024 have risen from $2.99 to $3.10. Shares of NVO have surged 47.8% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.