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Merck's (MRK) Pneumococcal Jab Gets FDA's Breakthrough Tag
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Merck & Co., Inc. (MRK - Free Report) announced that the FDA has granted Breakthrough Therapy designation to its investigational 21-valent pneumococcal conjugate vaccine, V116, for the prevention of invasive pneumococcal disease (“IPD”) and pneumococcal pneumonia in adults.
A Breakthrough Therapy status is granted to medicines being evaluated for serious conditions where early clinical evidence indicates said medicines’ potential for substantial improvement over available therapies.
The FDA’s Breakthrough Therapy tag was based on data from a two-part randomized, double-blind phase I/II study that evaluated the safety, tolerability and immunogenicity of a single dose of V116 in pneumococcal vaccine-naïve adults aged between 18 to 49 years in phase I and in those who are 50 years and above in phase II.
Merck plans to initiate phase III studies on V116 later in 2022.
Per the company, V116 targets serotypes that account for 85% of all IPD in individuals aged 65 and above in the United States as of 2019. The vaccine is being developed to prevent IPD and pneumococcal pneumonia caused by streptococcus pneumoniae serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F and 35B in adults.
Shares of Merck have rallied 13.4% so far this year compared with the industry’s growth of 7.3%.
Image Source: Zacks Investment Research
Merck’s 15-valent pneumococcal conjugate vaccine (“PCV”), Vaxneuvance (V114), was approved by the FDA for use in adults in June last year. The vaccine was approved by the European Commission in December 2021.
Earlier this month, the FDA delayed its decision on the supplemental biologics license application (sBLA) seeking approval for Vaxneuvance for use in children and infants, by three months. The FDA’s decision is now expected on Jul 1 this year.
The regulatory body needs more time to analyze Merck’s data from the pediatric studies on Vaxneuvance, which has been cited as a reason for the delay.
Apart from Vaxneuvance, Merck has a strong vaccine portfolio led by its human papillomavirus vaccine, Gardasil. The company also has a 23-valent PCV, Pneumovax 23, in its portfolio. It also has a commercialized shingles vaccine, Zostavax. However, Zostavax faces strong competition from the popular shingles vaccine, Shingrix, by Glaxo (GSK - Free Report) .
Glaxo received the first FDA approval for Shingrix in 2017. The approval was followed by multiple label expansions over the years. Glaxo recorded approximately £ 1.7 billion in sales from Shingrix in 2021.
Meanwhile, Pfizer’s (PFE - Free Report) Prevnar-20, a 20-valent PCV, was also approved in the United States in June last year and in Europe in February 2022 (to be marketed as Apexxnar).
Prevnar 20 includes all the 13 serotypes contained in Pfizer’s popular 13-valent pneumococcal conjugate vaccine, Prevnar 13, along with seven additional serotypes. Pfizer is also conducting studies to evaluate the co-administration of its Prevnar-20 vaccine with its COVID-19 vaccine.
Zacks Rank & Key Pick
Merck currently carries a Zacks Rank of #3 (Hold).
The Zacks Consensus Estimate for Collegium Pharmaceutical’s earnings has been revised 47.4% upward for 2022 and 55.3% for 2023 over the past 60 days. The COLL stock has gained 2.7% year to date.
Earnings of Collegium Pharmaceutical surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.
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Merck's (MRK) Pneumococcal Jab Gets FDA's Breakthrough Tag
Merck & Co., Inc. (MRK - Free Report) announced that the FDA has granted Breakthrough Therapy designation to its investigational 21-valent pneumococcal conjugate vaccine, V116, for the prevention of invasive pneumococcal disease (“IPD”) and pneumococcal pneumonia in adults.
A Breakthrough Therapy status is granted to medicines being evaluated for serious conditions where early clinical evidence indicates said medicines’ potential for substantial improvement over available therapies.
The FDA’s Breakthrough Therapy tag was based on data from a two-part randomized, double-blind phase I/II study that evaluated the safety, tolerability and immunogenicity of a single dose of V116 in pneumococcal vaccine-naïve adults aged between 18 to 49 years in phase I and in those who are 50 years and above in phase II.
Merck plans to initiate phase III studies on V116 later in 2022.
Per the company, V116 targets serotypes that account for 85% of all IPD in individuals aged 65 and above in the United States as of 2019. The vaccine is being developed to prevent IPD and pneumococcal pneumonia caused by streptococcus pneumoniae serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F and 35B in adults.
Shares of Merck have rallied 13.4% so far this year compared with the industry’s growth of 7.3%.
Image Source: Zacks Investment Research
Merck’s 15-valent pneumococcal conjugate vaccine (“PCV”), Vaxneuvance (V114), was approved by the FDA for use in adults in June last year. The vaccine was approved by the European Commission in December 2021.
Earlier this month, the FDA delayed its decision on the supplemental biologics license application (sBLA) seeking approval for Vaxneuvance for use in children and infants, by three months. The FDA’s decision is now expected on Jul 1 this year.
The regulatory body needs more time to analyze Merck’s data from the pediatric studies on Vaxneuvance, which has been cited as a reason for the delay.
Apart from Vaxneuvance, Merck has a strong vaccine portfolio led by its human papillomavirus vaccine, Gardasil. The company also has a 23-valent PCV, Pneumovax 23, in its portfolio. It also has a commercialized shingles vaccine, Zostavax. However, Zostavax faces strong competition from the popular shingles vaccine, Shingrix, by Glaxo (GSK - Free Report) .
Glaxo received the first FDA approval for Shingrix in 2017. The approval was followed by multiple label expansions over the years. Glaxo recorded approximately £ 1.7 billion in sales from Shingrix in 2021.
Meanwhile, Pfizer’s (PFE - Free Report) Prevnar-20, a 20-valent PCV, was also approved in the United States in June last year and in Europe in February 2022 (to be marketed as Apexxnar).
Prevnar 20 includes all the 13 serotypes contained in Pfizer’s popular 13-valent pneumococcal conjugate vaccine, Prevnar 13, along with seven additional serotypes. Pfizer is also conducting studies to evaluate the co-administration of its Prevnar-20 vaccine with its COVID-19 vaccine.
Zacks Rank & Key Pick
Merck currently carries a Zacks Rank of #3 (Hold).
A top-ranked stock in the healthcare sector is Collegium Pharmaceutical, Inc. (COLL - Free Report) , which has a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
The Zacks Consensus Estimate for Collegium Pharmaceutical’s earnings has been revised 47.4% upward for 2022 and 55.3% for 2023 over the past 60 days. The COLL stock has gained 2.7% year to date.
Earnings of Collegium Pharmaceutical surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.