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Bristol-Myers' Reblozyl to be Reviewed by FDA Committee
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Bristol-Myers Squibb Company (BMY - Free Report) and Acceleron Pharma Inc. announced that the FDA’s Oncologic Drugs Advisory Committee will hold a review of their supplemental Biologics License Application (sBLA) for Reblozyl (luspatercept-aamt) in patients with myelodysplastic syndromes (MDS) at the meeting on Dec 18.
Bristol-Myers Squibb is seeking approval of Reblozyl for the treatment of adult patients with very low- to intermediate-risk MDS-associated anemia, who have ring sideroblasts and require red blood cell (RBC) transfusions. The FDA has set a target action date of Apr 4, 2020, for the same.
Shares of the company have gained 11.1% year to date compared with the industry’s growth of 5.7%.
We remind investors that in November, the FDA Reblozyl for the treatment of anemia in adult patients with beta thalassemia, who require RBC transfusions. The drug is the first and only FDA-approved erythroid maturation agent, representing a new class of therapy for these patients. The approval came ahead of the target action date of Dec 4.
Additionally, a phase II study (BEYOND) in adult patients with non-transfusion-dependent beta thalassemia, a phase III study (COMMANDS) in ESA-naïve, lower-risk MDS patients and a phase II study in myelofibrosis patients are ongoing.
We remind investors that Bristol-Myers recently completed the acquisition of Celgene Corporation, with an equity value of approximately $74 billion, to boost its oncology franchise.
GlaxoSmithKline’s earnings per share estimates have increased from $2.96 to $3.08 for 2019 and from $3.01 to $3.02 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 17.23%, on average.
Merck’s earnings per share estimates have increased from $4.91 to $5.15 for 2019 and from $5.38 to $5.49 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 12.51%, on average.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity. A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
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Bristol-Myers' Reblozyl to be Reviewed by FDA Committee
Bristol-Myers Squibb Company (BMY - Free Report) and Acceleron Pharma Inc. announced that the FDA’s Oncologic Drugs Advisory Committee will hold a review of their supplemental Biologics License Application (sBLA) for Reblozyl (luspatercept-aamt) in patients with myelodysplastic syndromes (MDS) at the meeting on Dec 18.
Bristol-Myers Squibb is seeking approval of Reblozyl for the treatment of adult patients with very low- to intermediate-risk MDS-associated anemia, who have ring sideroblasts and require red blood cell (RBC) transfusions. The FDA has set a target action date of Apr 4, 2020, for the same.
Shares of the company have gained 11.1% year to date compared with the industry’s growth of 5.7%.
We remind investors that in November, the FDA Reblozyl for the treatment of anemia in adult patients with beta thalassemia, who require RBC transfusions. The drug is the first and only FDA-approved erythroid maturation agent, representing a new class of therapy for these patients. The approval came ahead of the target action date of Dec 4.
Additionally, a phase II study (BEYOND) in adult patients with non-transfusion-dependent beta thalassemia, a phase III study (COMMANDS) in ESA-naïve, lower-risk MDS patients and a phase II study in myelofibrosis patients are ongoing.
We remind investors that Bristol-Myers recently completed the acquisition of Celgene Corporation, with an equity value of approximately $74 billion, to boost its oncology franchise.
Bristol-Myers Squibb Company Price
Bristol-Myers Squibb Company price | Bristol-Myers Squibb Company Quote
Zacks Rank & Other Stocks to Consider
Bristol-Myers currently carries a Zacks Rank #2 (Buy).
A few other similar-ranked stocks in the same sector are GlaxoSmithKline plc. (GSK - Free Report) and Merck & Co. Inc. (MRK - Free Report) . You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
GlaxoSmithKline’s earnings per share estimates have increased from $2.96 to $3.08 for 2019 and from $3.01 to $3.02 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 17.23%, on average.
Merck’s earnings per share estimates have increased from $4.91 to $5.15 for 2019 and from $5.38 to $5.49 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 12.51%, on average.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity. A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>