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Bristol Myers (BMY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has 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.
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells.
The positive opinion of the CHMP was based on results from the phase III TRANSFORM study. The study evaluated Breyanzi as a second-line treatment in adults with relapsed or refractory LBCL compared to the standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus hematopoietic stem cell transplant (HSCT).
A final decision from the European Commission (EC) is expected within two months following receipt of the CHMP opinion. While the EC considers the opinion, it is not bound by it.
Bristol Myers Squibb Company Price, Consensus and EPS Surprise
We note that the FDA has already approved Breyanzi for treating certain adult patients with large B-cell lymphoma (LBCL), including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), HGBCL, and follicular lymphoma grade 3B, who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy, or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for HSCT due to comorbidities or age, or relapsed or refractory disease after two or more lines of systemic therapy.
It is also approved in Japan for the second-line treatment of relapsed or refractory LBCL and in Japan, Europe, Switzerland and Canada for relapsed or refractory LBCL after two or more lines of systemic therapy.
Breyanzi generated sales of $182 million in 2022. Approval for additional indications will further boost the growth potential of the drug.
While the CAR T space has potential, competition is stiff from Gilead’s (GILD - Free Report) Yescarta and Novartis’ (NVS - Free Report) Kymriah, among others.
Gilead’s Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy and adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL (not otherwise specified) primary mediastinal large B-cell lymphoma, HGBCL and DLBCL arising from follicular lymphoma.
Novartis’ Kymriah is approved for the treatment of elapsed or refractory (r/r) pediatric and young adult (up to and including 25 years of age) acute lymphoblastic leukemia (ALL), r/r adult DLBCL and r/r adult follicular lymphoma.
Shares of Bristol Myers have lost 6.1% in the past year compared with the industry’s decline of 16.6%.
Image Source: Zacks Investment Research
The approval of potential new drugs will add an incremental revenue stream to boost growth in the coming quarters and offset the slowdown in 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 EC recently approved Sotyktu (deucravacitinib) for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
The FDA approved a new, first-in-class, fixed-dose combination of the PD-1 inhibitor Opdivo (nivolumab) and relatlimab (a 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 class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms.
The EC also granted full marketing authorization for Reblozyl (luspatercept) treatment in adult patients of anemia associated with non-transfusion dependent beta-thalassemia.
Image: Bigstock
Bristol Myers' (BMY) Breyanzi Gets Positive CHMP Opinion
Bristol Myers (BMY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has 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.
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells.
The positive opinion of the CHMP was based on results from the phase III TRANSFORM study. The study evaluated Breyanzi as a second-line treatment in adults with relapsed or refractory LBCL compared to the standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus hematopoietic stem cell transplant (HSCT).
A final decision from the European Commission (EC) is expected within two months following receipt of the CHMP opinion. While the EC considers the opinion, it is not bound by it.
Bristol Myers Squibb Company Price, Consensus and EPS Surprise
Bristol Myers Squibb Company price-consensus-eps-surprise-chart | Bristol Myers Squibb Company Quote
We note that the FDA has already approved Breyanzi for treating certain adult patients with large B-cell lymphoma (LBCL), including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), HGBCL, and follicular lymphoma grade 3B, who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy, or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for HSCT due to comorbidities or age, or relapsed or refractory disease after two or more lines of systemic therapy.
It is also approved in Japan for the second-line treatment of relapsed or refractory LBCL and in Japan, Europe, Switzerland and Canada for relapsed or refractory LBCL after two or more lines of systemic therapy.
Breyanzi generated sales of $182 million in 2022. Approval for additional indications will further boost the growth potential of the drug.
While the CAR T space has potential, competition is stiff from Gilead’s (GILD - Free Report) Yescarta and Novartis’ (NVS - Free Report) Kymriah, among others.
Gilead’s Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy and adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL (not otherwise specified) primary mediastinal large B-cell lymphoma, HGBCL and DLBCL arising from follicular lymphoma.
Novartis’ Kymriah is approved for the treatment of elapsed or refractory (r/r) pediatric and young adult (up to and including 25 years of age) acute lymphoblastic leukemia (ALL), r/r adult DLBCL and r/r adult follicular lymphoma.
Shares of Bristol Myers have lost 6.1% in the past year compared with the industry’s decline of 16.6%.
Image Source: Zacks Investment Research
The approval of potential new drugs will add an incremental revenue stream to boost growth in the coming quarters and offset the slowdown in 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 EC recently approved Sotyktu (deucravacitinib) for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
The FDA approved a new, first-in-class, fixed-dose combination of the PD-1 inhibitor Opdivo (nivolumab) and relatlimab (a 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 class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms.
The EC also granted full marketing authorization for Reblozyl (luspatercept) treatment in adult patients of anemia associated with non-transfusion dependent beta-thalassemia.
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.