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Bristol Myers (BMY) sBLA for Reblozyl Gets Priority Review
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Bristol Myers Squibb (BMY - Free Report) recently announced that the FDA has accepted for priority review the supplemental biologics license application (sBLA) for Reblozyl (luspatercept-aamt), a first-in-class erythroid maturation agent.
The sBLA is seeking label expansion of the drug for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia.
The FDA has set a target action date of Mar 27, 2022.
In addition, the European Medicines Agency (“EMA”) has validated the type II variation for Reblozyl in NTD beta thalassemia.
These applications were based on safety and efficacy results from the phase II BEYOND study evaluating Reblozyl plus best supportive care in patients with NTD beta thalassemia.
NTD beta thalassemia patients do not require lifelong regular transfusions for survival.
Reblozyl is currently approved in the United States for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. It is also approved for anemia failing an erythropoiesis-stimulating agent and requiring two or more red blood cell units over eight weeks in adult patients with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
Reblozyl generated sales of $160 million in the third quarter of 2021 and $400 million in the first nine months. A potential label expansion will rake in more sales.
Please note that Bristol Myers is currently co-developing Reblozyl with Merck (MRK - Free Report) after the latter’s recent acquisition of the erstwhile Acceleron Pharma, Inc.
Merck acquired Acceleron for $180 per share in cash for an approximate total equity value of $11.5 billion in a bid to build its rare diseases portfolio.
Bristol-Myers is looking to counter the generic threat and competition to its key drugs through new drug approvals and diversification of the top line.
Shares of the company have lost 9.2% year to date compared with the industry's decline of 19.5%.
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The FDA recently accepted the new drug application (NDA) for deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of treat adults with moderate-to-severe plaque psoriasis. The EMA also validated the marketing authorization application (MAA) for the same.
BMY also obtained the FDA approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed CAR T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), at the start of this year. Further, Bristol-Myers won the FDA approval for Abecma, a first-in-class B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy.
Loss per share estimates for Sarepta have narrowed from $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 30 days. SRPT delivered an earnings surprise of 11.06%, on average, in the last four quarters.
Loss per share estimates for Viking Therapeutics have narrowed to $3.16 from $3.55 for 2021 and to $3.47 from $3.63 for 2022 in the past 30 days. VKTX delivered an earnings surprise of 2.06%, on average, in the last four quarters.
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Bristol Myers (BMY) sBLA for Reblozyl Gets Priority Review
Bristol Myers Squibb (BMY - Free Report) recently announced that the FDA has accepted for priority review the supplemental biologics license application (sBLA) for Reblozyl (luspatercept-aamt), a first-in-class erythroid maturation agent.
The sBLA is seeking label expansion of the drug for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia.
The FDA has set a target action date of Mar 27, 2022.
In addition, the European Medicines Agency (“EMA”) has validated the type II variation for Reblozyl in NTD beta thalassemia.
These applications were based on safety and efficacy results from the phase II BEYOND study evaluating Reblozyl plus best supportive care in patients with NTD beta thalassemia.
NTD beta thalassemia patients do not require lifelong regular transfusions for survival.
Reblozyl is currently approved in the United States for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. It is also approved for anemia failing an erythropoiesis-stimulating agent and requiring two or more red blood cell units over eight weeks in adult patients with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
Reblozyl generated sales of $160 million in the third quarter of 2021 and $400 million in the first nine months. A potential label expansion will rake in more sales.
Please note that Bristol Myers is currently co-developing Reblozyl with Merck (MRK - Free Report) after the latter’s recent acquisition of the erstwhile Acceleron Pharma, Inc.
Merck acquired Acceleron for $180 per share in cash for an approximate total equity value of $11.5 billion in a bid to build its rare diseases portfolio.
Bristol-Myers is looking to counter the generic threat and competition to its key drugs through new drug approvals and diversification of the top line.
Shares of the company have lost 9.2% year to date compared with the industry's decline of 19.5%.
The FDA recently accepted the new drug application (NDA) for deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of treat adults with moderate-to-severe plaque psoriasis. The EMA also validated the marketing authorization application (MAA) for the same.
BMY also obtained the FDA approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed CAR T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), at the start of this year. Further, Bristol-Myers won the FDA approval for Abecma, a first-in-class B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy.
Bristol Myers currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector are Sarepta Therapeutics, Inc. (SRPT - Free Report) and Viking Therapeutics (VKTX - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Sarepta have narrowed from $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 30 days. SRPT delivered an earnings surprise of 11.06%, on average, in the last four quarters.
Loss per share estimates for Viking Therapeutics have narrowed to $3.16 from $3.55 for 2021 and to $3.47 from $3.63 for 2022 in the past 30 days. VKTX delivered an earnings surprise of 2.06%, on average, in the last four quarters.