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Bristol Myers (BMY) Wins EC Nod for Reblozyl Label Expansion
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Bristol Myers Squibb (BMY - Free Report) announced that the European Commission (EC) has approved a label expansion of Reblozyl (luspatercept).
The EC expanded the drug’s label to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). The approval of Reblozyl covers all European Union (EU) member states.
The latest approval is based on results of the late-stage COMMANDS study, wherein Reblozyl demonstrated superior efficacy compared to epoetin alfa in the study’s primary endpoint of concurrent red blood cell (RBC) transfusion independence and hemoglobin increase. Safety results were consistent with previous MDS studies and in line with expected symptoms in this patient population.
MDS is a group of closely related blood cancers marked by ineffective production of healthy RBC, white blood cells and platelets that can lead to anemia and frequent or severe infections.
Reblozyl is already indicated in the EU for the treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk MDS with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy. It is also indicated for the treatment of adult patients with anemia, associated with transfusion-dependent and non-transfusion-dependent beta-thalassemia.
In the United States, Reblozyl is indicated for the treatment of anemia in adult patients with beta-thalassemia who require regular RBC transfusions. It is also indicated to treat anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low to intermediate-risk MDS who may require regular RBC transfusions. The drug is also approved for treating anemia failing an erythropoiesis stimulating agent and requiring two or more RBC units over eight weeks in adult patients with very low to intermediate-risk myelodysplastic syndrome with ring sideroblasts or myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis.
Reblozyl, a key drug in BMY’s new product portfolio, put up a strong performance in 2023. It generated sales of more than $1 billion in 2023. The label expansion of the drug will boost sales further.
Reblozyl is being developed and commercialized through global collaboration and North American co-promotion with Merck, following its acquisition of Acceleron Pharma, Inc. in November 2021.
Shares of Bristol Myers have plunged 23.5% in the past year compared with the industry’s decline of 4.2%.
Image Source: Zacks Investment Research
BMY is looking to expand its new product portfolio amid generic challenges for Revlimid and Eliquis. The going has been good in that regard.
The EC also recently approved a label expansion for chimeric antigen receptor (CAR) T cell immunotherapy Abecma. The therapy is now approved in the EU in earlier lines for triple-class exposed relapsed and refractory multiple myeloma.
Earlier, Bristol Myers and partner 2seventy bio announced that the FDA Oncologic Drugs Advisory Committee voted in favor (8:3) of Abecma’s benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma.
The FDA also granted accelerated approval to BMY’s other CAR T cell therapy, Breyanzi (lisocabtagene maraleucel), for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.
However, BMY announced that a late-stage study on orally-administered Zeposia (ozanimod) in Crohn’s disease indication failed to achieve its primary endpoint. The drug is approved for the treatment of adults with relapsing forms of multiple sclerosis in various countries.
Zacks Rank & Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have improved from 22 to 30 cents. In the past year, shares of ADMA have surged 100%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met once, delivering an average surprise of 85.00%.
In the past 60 days, estimates for GLPG’s loss have narrowed from $1.68 per share to 40 cents.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have improved from $4.06 to $4.43. In the past year, shares of ANIP have surged 76.9%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 109.06%.
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Bristol Myers (BMY) Wins EC Nod for Reblozyl Label Expansion
Bristol Myers Squibb (BMY - Free Report) announced that the European Commission (EC) has approved a label expansion of Reblozyl (luspatercept).
The EC expanded the drug’s label to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). The approval of Reblozyl covers all European Union (EU) member states.
The latest approval is based on results of the late-stage COMMANDS study, wherein Reblozyl demonstrated superior efficacy compared to epoetin alfa in the study’s primary endpoint of concurrent red blood cell (RBC) transfusion independence and hemoglobin increase. Safety results were consistent with previous MDS studies and in line with expected symptoms in this patient population.
MDS is a group of closely related blood cancers marked by ineffective production of healthy RBC, white blood cells and platelets that can lead to anemia and frequent or severe infections.
Reblozyl is already indicated in the EU for the treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk MDS with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy. It is also indicated for the treatment of adult patients with anemia, associated with transfusion-dependent and non-transfusion-dependent beta-thalassemia.
In the United States, Reblozyl is indicated for the treatment of anemia in adult patients with beta-thalassemia who require regular RBC transfusions. It is also indicated to treat anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low to intermediate-risk MDS who may require regular RBC transfusions. The drug is also approved for treating anemia failing an erythropoiesis stimulating agent and requiring two or more RBC units over eight weeks in adult patients with very low to intermediate-risk myelodysplastic syndrome with ring sideroblasts or myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis.
Reblozyl, a key drug in BMY’s new product portfolio, put up a strong performance in 2023. It generated sales of more than $1 billion in 2023. The label expansion of the drug will boost sales further.
Reblozyl is being developed and commercialized through global collaboration and North American co-promotion with Merck, following its acquisition of Acceleron Pharma, Inc. in November 2021.
Shares of Bristol Myers have plunged 23.5% in the past year compared with the industry’s decline of 4.2%.
Image Source: Zacks Investment Research
BMY is looking to expand its new product portfolio amid generic challenges for Revlimid and Eliquis. The going has been good in that regard.
The EC also recently approved a label expansion for chimeric antigen receptor (CAR) T cell immunotherapy Abecma. The therapy is now approved in the EU in earlier lines for triple-class exposed relapsed and refractory multiple myeloma.
Earlier, Bristol Myers and partner 2seventy bio announced that the FDA Oncologic Drugs Advisory Committee voted in favor (8:3) of Abecma’s benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma.
The FDA also granted accelerated approval to BMY’s other CAR T cell therapy, Breyanzi (lisocabtagene maraleucel), for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.
However, BMY announced that a late-stage study on orally-administered Zeposia (ozanimod) in Crohn’s disease indication failed to achieve its primary endpoint. The drug is approved for the treatment of adults with relapsing forms of multiple sclerosis in various countries.
Zacks Rank & Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the biotech sector are ADMA Biologics, Inc. (ADMA - Free Report) , Galapagos (GLPG - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - 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 ADMA Biologics’ 2024 earnings per share (EPS) have improved from 22 to 30 cents. In the past year, shares of ADMA have surged 100%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met once, delivering an average surprise of 85.00%.
In the past 60 days, estimates for GLPG’s loss have narrowed from $1.68 per share to 40 cents.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have improved from $4.06 to $4.43. In the past year, shares of ANIP have surged 76.9%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 109.06%.