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Bristol Myers (BMY) Gets Positive CHMP Opinion for Inrebic
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Bristol Myers Squibb (BMY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Inrebic (fedratinib) for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, who are Janus Associated Kinase (JAK) inhibitor naive or have been treated with ruxolitinib. Myelofibrosis is a serious and rare bone marrow disorder that disrupts the body’s normal production of blood cells.
Shares of Bristol Myers have decreased 2.5% against the industry’s growth of 8.1%.
The CHMP recommendation will be reviewed by the European Commission (EC). The EC is expected to deliver its final decision within 67 days of the receipt of the CHMP opinion.
If approved, Inrebic will become the first new therapy for myelofibrosis in Europe in almost a decade. Inrebic, if approved, will also be the first once-daily, oral therapy to show clinically meaningful spleen and symptom response for patients with myelofibrosis where treatment with ruxolitinib failed or who are JAK inhibitor naive.
We note that Inrebic is approved in the United States for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis.
The CHMP recommendation was supported by results from the JAKARTA and JAKARTA2 studies. The primary endpoint of JAKARTA and JAKARTA2 was the spleen response rate, defined as the proportion of patients achieving greater than or equal to a 35% reduction from baseline in spleen volume at the end of cycle 6. In JAKARTA study, spleen volume was reduced by 35% or greater, when assessed from baseline to the end of cycle 6 (week 24), with a 4-week follow-up scan, in 37% (35 of 96) of patients treated with INREBIC 400 mg versus 1% (1 of 96) of patients who received placebo
The approval will lead to increased sales for the company.
Aerpio’s loss per share estimates have narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days.
Aptose’s loss per share estimates have narrowed from 77 cents to 69 cents for 2020 and from 85 cents to 81 cents for 2021 over the past 60 days.
Alimera’s loss per share estimates have narrowed from $1.31 to 96 cents for 2020 over the past 60 days.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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Bristol Myers (BMY) Gets Positive CHMP Opinion for Inrebic
Bristol Myers Squibb (BMY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Inrebic (fedratinib) for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, who are Janus Associated Kinase (JAK) inhibitor naive or have been treated with ruxolitinib. Myelofibrosis is a serious and rare bone marrow disorder that disrupts the body’s normal production of blood cells.
Shares of Bristol Myers have decreased 2.5% against the industry’s growth of 8.1%.
The CHMP recommendation will be reviewed by the European Commission (EC). The EC is expected to deliver its final decision within 67 days of the receipt of the CHMP opinion.
If approved, Inrebic will become the first new therapy for myelofibrosis in Europe in almost a decade. Inrebic, if approved, will also be the first once-daily, oral therapy to show clinically meaningful spleen and symptom response for patients with myelofibrosis where treatment with ruxolitinib failed or who are JAK inhibitor naive.
We note that Inrebic is approved in the United States for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis.
The CHMP recommendation was supported by results from the JAKARTA and JAKARTA2 studies. The primary endpoint of JAKARTA and JAKARTA2 was the spleen response rate, defined as the proportion of patients achieving greater than or equal to a 35% reduction from baseline in spleen volume at the end of cycle 6. In JAKARTA study, spleen volume was reduced by 35% or greater, when assessed from baseline to the end of cycle 6 (week 24), with a 4-week follow-up scan, in 37% (35 of 96) of patients treated with INREBIC 400 mg versus 1% (1 of 96) of patients who received placebo
The approval will lead to increased sales for the company.
Bristol Myers Squibb Company Price
Bristol Myers Squibb Company price | Bristol Myers Squibb Company Quote
Zacks Rank & Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Aerpio Pharmaceuticals Ltd. , Aptose Biosciences Inc. (APTO - Free Report) and Alimera Sciences Inc. (ALIM - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aerpio’s loss per share estimates have narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days.
Aptose’s loss per share estimates have narrowed from 77 cents to 69 cents for 2020 and from 85 cents to 81 cents for 2021 over the past 60 days.
Alimera’s loss per share estimates have narrowed from $1.31 to 96 cents for 2020 over the past 60 days.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>