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Bristol Myers (BMY) Gets EC Nod for CAR T Cell Therapy Breyanzi
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Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Commission (“EC”) has approved its CD19-directed CAR-T cell therapy, Breyanzi (lisocabtagene maraleucel), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (“DLBCL”), primary mediastinal large B-cell lymphoma (“PMBCL”) and follicular lymphoma grade 3B (FL3B), following two or more lines of systemic therapy.
The EC approval of Breyanzi is based on data from the TRANSCEND NHL 001 study, which evaluated Breyanzi in adult patients with R/R DLBCL, PMBCL and FL3B, including those with a broad range of histologies and high-risk disease.
Per the company, out of the 216 patients who received treatment with Breyanzi, 73% achieved a response, including 53% who had minimal or no detectable lymphoma remaining after treatment. Breyanzi demonstrated rapid and durable complete responses and a manageable safety profile.
Shares of Bristol Myers have rallied 19.4% so far this year against the industry’s decline of 10.9%.
Image Source: Zacks Investment Research
The FDA approved Breyanzi in February 2021 for the treatment of adult patients with R/R large B-cell lymphoma or LBCL after two or more lines of systemic therapy, including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, PMBCL, and FL3B.
In February 2022, the FDA accepted and granted priority review to the supplemental biologics license application (sBLA) seeking approval for Breyanzi for the treatment of adult patients with R/R LBCL after the failure of first-line therapy. A decision from the regulatory body is expected on Jun 24, 2022.
Breyanzi generated sales worth $87 million in 2021. The latest approval in Europe and a potential label expansion of the drug should also boost its sales in 2022 and beyond.
In 2021, Bristol Myers obtained 20 approvals for new drugs besides additional indications and formulations of currently marketed drugs in major markets, including regulatory approvals of Breyanzi and Abecma in hematology malignancies.
Approval of new drugs has added a new stream of revenues for Bristol Myers, which should propel growth in future quarters.
Image: Shutterstock
Bristol Myers (BMY) Gets EC Nod for CAR T Cell Therapy Breyanzi
Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Commission (“EC”) has approved its CD19-directed CAR-T cell therapy, Breyanzi (lisocabtagene maraleucel), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (“DLBCL”), primary mediastinal large B-cell lymphoma (“PMBCL”) and follicular lymphoma grade 3B (FL3B), following two or more lines of systemic therapy.
The EC approval of Breyanzi is based on data from the TRANSCEND NHL 001 study, which evaluated Breyanzi in adult patients with R/R DLBCL, PMBCL and FL3B, including those with a broad range of histologies and high-risk disease.
Per the company, out of the 216 patients who received treatment with Breyanzi, 73% achieved a response, including 53% who had minimal or no detectable lymphoma remaining after treatment. Breyanzi demonstrated rapid and durable complete responses and a manageable safety profile.
Shares of Bristol Myers have rallied 19.4% so far this year against the industry’s decline of 10.9%.
Image Source: Zacks Investment Research
The FDA approved Breyanzi in February 2021 for the treatment of adult patients with R/R large B-cell lymphoma or LBCL after two or more lines of systemic therapy, including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, PMBCL, and FL3B.
In February 2022, the FDA accepted and granted priority review to the supplemental biologics license application (sBLA) seeking approval for Breyanzi for the treatment of adult patients with R/R LBCL after the failure of first-line therapy. A decision from the regulatory body is expected on Jun 24, 2022.
Breyanzi generated sales worth $87 million in 2021. The latest approval in Europe and a potential label expansion of the drug should also boost its sales in 2022 and beyond.
In 2021, Bristol Myers obtained 20 approvals for new drugs besides additional indications and formulations of currently marketed drugs in major markets, including regulatory approvals of Breyanzi and Abecma in hematology malignancies.
Approval of new drugs has added a new stream of revenues for Bristol Myers, which should propel growth in future quarters.
Zacks Rank & Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Galera Therapeutics, Inc. (GRTX - Free Report) , Applied Therapeutics, Inc. (APLT - Free Report) and Voyager Therapeutics, Inc. (VYGR - Free Report) , all sporting a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Galera Therapeutics’ loss per share has narrowed 30.6% for 2022 over the past 60 days.
Earnings of GRTX surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions.
Applied Therapeutics’ loss per share estimates have narrowed 18.7% for 2022 over the past 60 days.
Earnings of APLT have surpassed estimates in two of the trailing four quarters, met the same once and missed the same on the other occasion.
Voyager Therapeutics’ loss per share estimates have narrowed 38.6% for 2022 over the past 60 days. The VYGR stock has skyrocketed 231.7% year to date.
Earnings of Voyager Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.