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Merck (MRK) Gets FDA Fast Track Tag for Anticoagulant Therapy
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Merck (MRK - Free Report) announced that the FDA has granted Fast Track designation to its pipeline candidate, MK-2060, an anticoagulant therapy for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).
Currently, a phase II study is ongoing on MK-2060 in people with ESRD receiving hemodialysis.
The FDA’s Fast Track status facilitates the development and expedites the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical needs.
Merck stock has risen 17.7% this year so far compared with an increase of 0.4% for the industry.
Image Source: Zacks Investment Research
Patients with ESRD face a high risk of thrombosis as well as high bleeding risk, creating the need for innovative anticoagulation medicines with low bleeding risk. Most of the anticoagulants approved for use are associated with significant bleeding, limiting their safe use. In order to develop effective and safer anticoagulants, Factor XI, a blood protein, is being actively pursued as a drug target. MK-2060 has been designed in a way to inhibit Factor XI’s ability to activate downstream proteins involved in the blood coagulation cascade.
Some other top-ranked stocks in the same sector are Bolt Biotherapeutics (BOLT - Free Report) , Catalyst Biosciences and Immunovant (IMVT - Free Report) , all carrying a Zacks Rank #2 at present.
Bolt Biotherapeutics’ loss estimates for 2022 have narrowed from $2.87 per share to $2.25 per share over the past 30 days. Loss estimates for 2023 have narrowed from $2.76 per share to $2.14 per share over the same time frame. Shares of Bolt Biotherapeutics have declined 60% this year so far.
Earnings of Bolt Biotherapeutics beat estimates in two of the last four quarters, while missing in one and delivering in-line results in one. The stock delivered a four-quarter surprise of 2.39%, on average.
Catalyst Biosciences’ loss per share estimates for 2022 have narrowed from $1.24 to 25 cents in the past 30 days. Loss estimates for 2023 have narrowed from 56 cents per share to 32 cents per share over the same time frame. Catalyst Biosciences’ stock is up 114.5% in the year-to-date period.
Earnings of Catalyst Biosciences beat estimates in two of the last four quarters, while missing in the other two. The stock delivered a four-quarter average negative surprise of 0.92%.
Immunovant’s stock is down 28.8% this year so far. Loss estimates for 2022 have narrowed from $1.66 per share to $1.64 per share while that for 2023 have improved from $1.94 per share to $1.75 per share over the past 30 days.
Earnings of Immunovant missed estimates in three of the last four quarters and beat the mark once, the average negative surprise being 8.97%.
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Merck (MRK) Gets FDA Fast Track Tag for Anticoagulant Therapy
Merck (MRK - Free Report) announced that the FDA has granted Fast Track designation to its pipeline candidate, MK-2060, an anticoagulant therapy for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).
Currently, a phase II study is ongoing on MK-2060 in people with ESRD receiving hemodialysis.
The FDA’s Fast Track status facilitates the development and expedites the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical needs.
Merck stock has risen 17.7% this year so far compared with an increase of 0.4% for the industry.
Image Source: Zacks Investment Research
Patients with ESRD face a high risk of thrombosis as well as high bleeding risk, creating the need for innovative anticoagulation medicines with low bleeding risk. Most of the anticoagulants approved for use are associated with significant bleeding, limiting their safe use. In order to develop effective and safer anticoagulants, Factor XI, a blood protein, is being actively pursued as a drug target. MK-2060 has been designed in a way to inhibit Factor XI’s ability to activate downstream proteins involved in the blood coagulation cascade.
Zacks Rank & Other Stocks to Consider
Merck has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some other top-ranked stocks in the same sector are Bolt Biotherapeutics (BOLT - Free Report) , Catalyst Biosciences and Immunovant (IMVT - Free Report) , all carrying a Zacks Rank #2 at present.
Bolt Biotherapeutics’ loss estimates for 2022 have narrowed from $2.87 per share to $2.25 per share over the past 30 days. Loss estimates for 2023 have narrowed from $2.76 per share to $2.14 per share over the same time frame. Shares of Bolt Biotherapeutics have declined 60% this year so far.
Earnings of Bolt Biotherapeutics beat estimates in two of the last four quarters, while missing in one and delivering in-line results in one. The stock delivered a four-quarter surprise of 2.39%, on average.
Catalyst Biosciences’ loss per share estimates for 2022 have narrowed from $1.24 to 25 cents in the past 30 days. Loss estimates for 2023 have narrowed from 56 cents per share to 32 cents per share over the same time frame. Catalyst Biosciences’ stock is up 114.5% in the year-to-date period.
Earnings of Catalyst Biosciences beat estimates in two of the last four quarters, while missing in the other two. The stock delivered a four-quarter average negative surprise of 0.92%.
Immunovant’s stock is down 28.8% this year so far. Loss estimates for 2022 have narrowed from $1.66 per share to $1.64 per share while that for 2023 have improved from $1.94 per share to $1.75 per share over the past 30 days.
Earnings of Immunovant missed estimates in three of the last four quarters and beat the mark once, the average negative surprise being 8.97%.