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Merck (MRK) Gets CHMP Nod for Expanded Use of Antiviral Drug
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Merck (MRK - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending expanded use of its antiviral medicine, Prevymis. Merck is seeking approval for label expansion for Prevymis to include prophylaxis (prevention) of cytomegalovirus (“CMV”) disease in adult kidney transplant recipients at high risk.
Merck is also seeking approval to allow the extended use of Prevymis from 100 days to 200 days in adult CMV-seropositive recipients receiving a hematopoietic stem cell transplant (HSCT) who are at risk of late CMV infection and disease. The CHMP has also recommended approval for this expanded use.
Prevymis was initially approved in the EU in 2018 for the prevention of clinically significant CMV infection in adult CMV-seropositive recipients of an allogeneic HSCT.
Merck’s stock has declined 6.1% so far this year against an increase of 8.9% for the industry.
Image Source: Zacks Investment Research
In the United States, Prevymis was approved for high-risk kidney transplant patients in June 2023 to help prevent CMV disease. The drug was approved for extended dosing to 200 HSCT recipients at risk of late CMV infection and disease in the United States in August. In the first half of 2023, Prevymis generated sales of $273 million, up 39% year over year.
Prevymis is part of Merck’s Hospital Acute Care product portfolio, which also includes products like Bridion injection, a medication for the reversal of two types of neuromuscular blocking agents used during surgery, Dificid for C. difficile-associated diarrhea and Zerbaxa a combination antibacterial and beta-lactamase inhibitor for the treatment of certain bacterial infections, among others.
Some top-ranked drug/biotech companies worth considering are Aurinia Pharmaceuticals (AUPH - Free Report) , MEI Pharma (MEIP - Free Report) and Alpine Immune Sciences (ALPN - Free Report) . While Aurinia Pharmaceuticals and MEI Pharma have a Zacks Rank #1 (Strong Buy) each, Alpine Immune Sciences has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, the loss per share estimate for Aurinia Pharmaceuticals for 2023 has narrowed from 71 cents per share to 58 cents per share, while that for 2024 has narrowed from 43 cents to 27 cents. Year to date, shares of Aurinia Pharmaceuticals have gained 81.5%.
Earnings of Aurinia Pharmaceuticals beat estimates in all the last four quarters, delivering an earnings surprise of 45.61% on average.
In the past 90 days, the Zacks Consensus Estimate for MEI Pharma’s loss per share has narrowed from $6.54 to $4.89 for 2023. The bottom-line estimate for 2024 has also improved from a loss of $5.14 to a loss of $4.02 during the same time frame. Shares of the company have rallied 40.0% year to date.
MEIP’s earnings beat estimates in three of the trailing four quarters while meeting the same in one, delivering an average earnings surprise of 53.58%.
In the past 90 days, the consensus estimate for Alpine Immune Sciences’ 2023 loss has narrowed from $1.43 per share to $1.18 per share, while the same for 2024 has narrowed from $1.73 per share to $1.47 per share. Year to date, shares of Alpine Immune Sciences have rallied 38.8%.
ALPN’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average negative earnings surprise of 79.65%.
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Merck (MRK) Gets CHMP Nod for Expanded Use of Antiviral Drug
Merck (MRK - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending expanded use of its antiviral medicine, Prevymis. Merck is seeking approval for label expansion for Prevymis to include prophylaxis (prevention) of cytomegalovirus (“CMV”) disease in adult kidney transplant recipients at high risk.
Merck is also seeking approval to allow the extended use of Prevymis from 100 days to 200 days in adult CMV-seropositive recipients receiving a hematopoietic stem cell transplant (HSCT) who are at risk of late CMV infection and disease. The CHMP has also recommended approval for this expanded use.
Prevymis was initially approved in the EU in 2018 for the prevention of clinically significant CMV infection in adult CMV-seropositive recipients of an allogeneic HSCT.
Merck’s stock has declined 6.1% so far this year against an increase of 8.9% for the industry.
Image Source: Zacks Investment Research
In the United States, Prevymis was approved for high-risk kidney transplant patients in June 2023 to help prevent CMV disease. The drug was approved for extended dosing to 200 HSCT recipients at risk of late CMV infection and disease in the United States in August. In the first half of 2023, Prevymis generated sales of $273 million, up 39% year over year.
Prevymis is part of Merck’s Hospital Acute Care product portfolio, which also includes products like Bridion injection, a medication for the reversal of two types of neuromuscular blocking agents used during surgery, Dificid for C. difficile-associated diarrhea and Zerbaxa a combination antibacterial and beta-lactamase inhibitor for the treatment of certain bacterial infections, among others.
Zacks Rank and Stocks to Consider
Merck has a Zacks Rank #3 (Hold) currently. You can see the complete list of today’s Zacks #1 Rank stocks (Strong Buy) here.
Merck & Co., Inc. Price and Consensus
Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote
Some top-ranked drug/biotech companies worth considering are Aurinia Pharmaceuticals (AUPH - Free Report) , MEI Pharma (MEIP - Free Report) and Alpine Immune Sciences (ALPN - Free Report) . While Aurinia Pharmaceuticals and MEI Pharma have a Zacks Rank #1 (Strong Buy) each, Alpine Immune Sciences has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, the loss per share estimate for Aurinia Pharmaceuticals for 2023 has narrowed from 71 cents per share to 58 cents per share, while that for 2024 has narrowed from 43 cents to 27 cents. Year to date, shares of Aurinia Pharmaceuticals have gained 81.5%.
Earnings of Aurinia Pharmaceuticals beat estimates in all the last four quarters, delivering an earnings surprise of 45.61% on average.
In the past 90 days, the Zacks Consensus Estimate for MEI Pharma’s loss per share has narrowed from $6.54 to $4.89 for 2023. The bottom-line estimate for 2024 has also improved from a loss of $5.14 to a loss of $4.02 during the same time frame. Shares of the company have rallied 40.0% year to date.
MEIP’s earnings beat estimates in three of the trailing four quarters while meeting the same in one, delivering an average earnings surprise of 53.58%.
In the past 90 days, the consensus estimate for Alpine Immune Sciences’ 2023 loss has narrowed from $1.43 per share to $1.18 per share, while the same for 2024 has narrowed from $1.73 per share to $1.47 per share. Year to date, shares of Alpine Immune Sciences have rallied 38.8%.
ALPN’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average negative earnings surprise of 79.65%.