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Will Bristol Myers (BMY) Gain From New Drugs' Label Expansion?
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Bristol-Myers Squibb (BMY - Free Report) has recently been enjoying a string of positive regulatory updates.
The company’s psoriasis drug Sotyktu (deucravacitinib) recently got approved by the European Commission (EC). Sotyktu is a first-in-class, selective tyrosine kinase 2 (TYK2) inhibitor for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, representing a new way of treating this chronic immune-mediated disease. It is already approved in the United States.
The psoriasis market holds a lot of potential and a strong uptake of Sotyktu will bode well for Bristol Myers.
Bristol Myers added deucravacitinib to its pipeline when it acquired Celgene in 2019 and had to let go of Otezla. In connection with the regulatory approval process for the transaction, Celgene sold the global rights to Otezla to Amgen.
Last month, the EC granted full Marketing Authorization to Reblozyl (luspatercept), a first-in-class therapeutic option, to treat adult patients with anemia associated with non-transfusion-dependent (NTD) beta thalassemia. The drug is approved in the European Union (EU), the United States and Canada to address anemia associated with transfusion-dependent beta thalassemia and transfusion-dependent lower-risk myelodysplastic syndromes.
Bristol Myers Squibb develops and commercializes Reblozyl through a global collaboration with medical powerhouse Merck (MRK - Free Report) . Merck acquired Acceleron Pharma in November 2021, following which Merck collaborated with BMY to develop and commercialize Reblozyl.
Earlier this week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) who relapsed within 12 months from completion of or are refractory to first-line chemoimmunotherapy.
BMY also announced the initiation of its pivotal Phase III Librexia program, which is studying milvexian, an investigational oral factor XIa (FXIa) inhibitor (antithrombotic), for the prevention and treatment of major thrombotic conditions. This clinical program will be conducted in partnership with Janssen Pharmaceutical, a subsidiary of pharma bigwig Johnson & Johnson.
In the past year, BMY’s shares have lost 9% compared with the industry’s fall of 15.8%.
Image Source: Zacks Investment Research
In February, the company reported better-than-expected results for the fourth quarter of 2022. Total revenues of $11.4 billion decreased 5% from the year-ago period due to generic competition for multiple myeloma (MM) drug, Revlimid and foreign exchange impacts, partially offset by in-line products (primarily Opdivo) and new product portfolios (primarily Opdualag and Abecma).
The approval of potential new drugs will add an incremental revenue stream to boost growth in the coming quarters and offset the slowdown in the top-line growth as one of Bristol Myers’ top drugs, Revlimid, is now facing generic competition, which is affecting the top line and threatens to erode sales rapidly.
The FDA had earlier approved a new, first-in-class, fixed-dose combination of PD-1 inhibitor Opdivo (nivolumab) and relatlimab (novel LAG-3-blocking antibody). It is administered as a single intravenous infusion to treat adult and pediatric patients aged 12 years or older with unresectable or metastatic melanoma (a kind of skin cancer) under the brand name Opdualag. The uptake of the drug has been encouraging so far.
Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg and 15 mg capsules) was approved in the United States for treating adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms.
Some better-ranked stocks in the overall healthcare sector are Novo Nordisk (NVO - Free Report) and Ligand Therapeutics (LGND - Free Report) , both sporting a Zacks Rank #1 at present.
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.43 to $4.51. Estimates for 2024 have increased 36 cents to $5.26.
Ligand’s earnings per share estimates for 2023 increased to $4.15 from $3.30 in the past 60 days. LGND beat earnings estimates in one of the last four reported quarters.
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Will Bristol Myers (BMY) Gain From New Drugs' Label Expansion?
Bristol-Myers Squibb (BMY - Free Report) has recently been enjoying a string of positive regulatory updates.
The company’s psoriasis drug Sotyktu (deucravacitinib) recently got approved by the European Commission (EC). Sotyktu is a first-in-class, selective tyrosine kinase 2 (TYK2) inhibitor for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, representing a new way of treating this chronic immune-mediated disease. It is already approved in the United States.
The psoriasis market holds a lot of potential and a strong uptake of Sotyktu will bode well for Bristol Myers.
Bristol Myers added deucravacitinib to its pipeline when it acquired Celgene in 2019 and had to let go of Otezla. In connection with the regulatory approval process for the transaction, Celgene sold the global rights to Otezla to Amgen.
Last month, the EC granted full Marketing Authorization to Reblozyl (luspatercept), a first-in-class therapeutic option, to treat adult patients with anemia associated with non-transfusion-dependent (NTD) beta thalassemia. The drug is approved in the European Union (EU), the United States and Canada to address anemia associated with transfusion-dependent beta thalassemia and transfusion-dependent lower-risk myelodysplastic syndromes.
Bristol Myers Squibb develops and commercializes Reblozyl through a global collaboration with medical powerhouse Merck (MRK - Free Report) . Merck acquired Acceleron Pharma in November 2021, following which Merck collaborated with BMY to develop and commercialize Reblozyl.
Earlier this week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) who relapsed within 12 months from completion of or are refractory to first-line chemoimmunotherapy.
BMY also announced the initiation of its pivotal Phase III Librexia program, which is studying milvexian, an investigational oral factor XIa (FXIa) inhibitor (antithrombotic), for the prevention and treatment of major thrombotic conditions. This clinical program will be conducted in partnership with Janssen Pharmaceutical, a subsidiary of pharma bigwig Johnson & Johnson.
In the past year, BMY’s shares have lost 9% compared with the industry’s fall of 15.8%.
Image Source: Zacks Investment Research
In February, the company reported better-than-expected results for the fourth quarter of 2022. Total revenues of $11.4 billion decreased 5% from the year-ago period due to generic competition for multiple myeloma (MM) drug, Revlimid and foreign exchange impacts, partially offset by in-line products (primarily Opdivo) and new product portfolios (primarily Opdualag and Abecma).
The approval of potential new drugs will add an incremental revenue stream to boost growth in the coming quarters and offset the slowdown in the top-line growth as one of Bristol Myers’ top drugs, Revlimid, is now facing generic competition, which is affecting the top line and threatens to erode sales rapidly.
The FDA had earlier approved a new, first-in-class, fixed-dose combination of PD-1 inhibitor Opdivo (nivolumab) and relatlimab (novel LAG-3-blocking antibody). It is administered as a single intravenous infusion to treat adult and pediatric patients aged 12 years or older with unresectable or metastatic melanoma (a kind of skin cancer) under the brand name Opdualag. The uptake of the drug has been encouraging so far.
Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg and 15 mg capsules) was approved in the United States for treating adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some better-ranked stocks in the overall healthcare sector are Novo Nordisk (NVO - Free Report) and Ligand Therapeutics (LGND - Free Report) , both sporting a Zacks Rank #1 at present.
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.43 to $4.51. Estimates for 2024 have increased 36 cents to $5.26.
Ligand’s earnings per share estimates for 2023 increased to $4.15 from $3.30 in the past 60 days. LGND beat earnings estimates in one of the last four reported quarters.