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MRK Begins 2nd Phase III Study on Rare Blood Disorder Candidate
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Merck (MRK - Free Report) announced that it has initiated a phase III called Shorespan-007 study on its lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat, for the treatment of patients with essential thrombocythemia (ET) who have previously not received cytoreductive therapy.
The pivotal phase III study is evaluating bomedemstat versus hydroxyurea, the current standard of care chemotherapy, for treating patients with ET, a chronic, rare blood disorder that is the most common type of myeloproliferative neoplasm (MPN).
The study will enroll approximately 300 patients globally.The primary endpoint of the study is to check the durable clinicohematologic response rate.
Shares of Merck have increased 6.9% so far this year compared with the industry’s rise of 27.1%.
Image Source: Zacks Investment Research
Which Studies are Ongoing on MRK's Bomedemstat?
Bomedemstat is also being evaluated in the phase III Shorespan-006 study for treating patients with ET who have an inadequate response to or are intolerant of hydroxyurea.
Also, multiple separate phase II studies are ongoing, which are evaluating bomedemstat either as a monotherapy or in combination for treating a wide range of MPNs such as ET, myelofibrosis (MF) and polycythemia vera (PV).
Bomedemstat was added to Merck’s portfolio with the 2022 acquisition of Imago BioSciences.
The FDA has granted Orphan Drug and Fast Track Designations to bomedemstat for the treatment of ET and MF, while the European Medicines Agency has granted Priority Medicines scheme designation to bomedemstat for MF.
The investigational LSD1 inhibitor, bomedemstat also enjoys an Orphan Drug designation from the FDA for the treatment of acute myeloid leukemia.
Per the company, less than 200,000 people suffer from ET in the United States, and the standard of care has remained unchanged for decades. As a result, the successful development of bomedemstat provides hope for a new treatment option that has the potential to improve disease control as well as the quality of life.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 6%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have rallied 59.8%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 31.3%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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MRK Begins 2nd Phase III Study on Rare Blood Disorder Candidate
Merck (MRK - Free Report) announced that it has initiated a phase III called Shorespan-007 study on its lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat, for the treatment of patients with essential thrombocythemia (ET) who have previously not received cytoreductive therapy.
The pivotal phase III study is evaluating bomedemstat versus hydroxyurea, the current standard of care chemotherapy, for treating patients with ET, a chronic, rare blood disorder that is the most common type of myeloproliferative neoplasm (MPN).
The study will enroll approximately 300 patients globally.The primary endpoint of the study is to check the durable clinicohematologic response rate.
Shares of Merck have increased 6.9% so far this year compared with the industry’s rise of 27.1%.
Image Source: Zacks Investment Research
Which Studies are Ongoing on MRK's Bomedemstat?
Bomedemstat is also being evaluated in the phase III Shorespan-006 study for treating patients with ET who have an inadequate response to or are intolerant of hydroxyurea.
Also, multiple separate phase II studies are ongoing, which are evaluating bomedemstat either as a monotherapy or in combination for treating a wide range of MPNs such as ET, myelofibrosis (MF) and polycythemia vera (PV).
Bomedemstat was added to Merck’s portfolio with the 2022 acquisition of Imago BioSciences.
The FDA has granted Orphan Drug and Fast Track Designations to bomedemstat for the treatment of ET and MF, while the European Medicines Agency has granted Priority Medicines scheme designation to bomedemstat for MF.
The investigational LSD1 inhibitor, bomedemstat also enjoys an Orphan Drug designation from the FDA for the treatment of acute myeloid leukemia.
Per the company, less than 200,000 people suffer from ET in the United States, and the standard of care has remained unchanged for decades. As a result, the successful development of bomedemstat provides hope for a new treatment option that has the potential to improve disease control as well as the quality of life.
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Illumina, Inc. (ILMN - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics, Inc. (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 6%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have rallied 59.8%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 31.3%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.