We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Bristol Myers (BMY) Gets FDA Nod for Breyanzi Label Expansion
Read MoreHide Full Article
Bristol Myers Squibb (BMY - Free Report) announced that the FDA has granted accelerated approval to the label expansion of chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel).
The regulatory body approved Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Breyanzi is already approved in the United Stated for treating relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy. The therapy was also granted accelerated approval to treat relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines of therapy.
Breyanzi is also approved in Japan, the European Union (EU) and Switzerland for the second-line treatment or relapsed or refractory LBCL, and in Japan, the EU, Switzerland, the U.K. and Canada for relapsed and refractory LBCL after two or more lines of systemic therapy.
About 95.7% of patients responded to Breyanzi in the TRANSCEND FL trial. Responses were rapid and durable with a median time to response of one month and median duration of response not reached. About 80.9% of responders remained in response at 12 months and 77.1% of responders remaining in response at 18 months.
Breyanzi is also now included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for B-cell Lymphomas as a Category 2A recommendation for third-line and subsequent therapy for relapsed or refractory FL.
Breyanzi sales came in at $107 million, up 51% from a year-ago quarter’s tally.
Sales will get a boost with consistent label expansions.
The company’s shares have lost 13.2% year to date compared with the industry's decline of 4.2%.
Image Source: Zacks Investment Research
Last month, the FDA approved a label expansion for BMY’s other CAR T cell therapy Abecma. The therapy is now approved for treating adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
Abecma is already approved in the United States for adult patients with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy.
It is to be noted that Abecma is being jointly developed and commercialized in the United States by Bristol Myers Squibb and 2seventy bio (TSVT - Free Report) . Outside the United States, BMY assumes the sole responsibility for Abecma’s manufacturing and commercialization.
TSVT expects that Abecma’s commercial performance will continue to be impacted by competitive dynamics as 2seventy bio and BMY launch Abecma into the earlier line setting and anticipate a return to growth in the second half of 2024.
However, CAR T cell therapies have been under FDA scrutiny of late. The FDA had earlier asked other companies to add ‘boxed warning’ to the labels of their T-cell immunotherapies.
Bristol Myers Squibb Company Price, Consensus and EPS Surprise
Approval of new drugs and label expansion of existing ones are important for BMY as the company looks to expand its portfolio. Bristol-Myers’ reported better-than-expected first-quarter results, as adjusted loss was narrower than expected and sales beat estimates. However, the decline in Opdivo sales was a dampener. Revlimid is already facing generic competition and Eliquis, too, is likely to face challenges later.
Zacks Rank & a Stock to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 and 2025 earnings per share (EPS) has remained constant at $4.56 and $5.27, respectively. Shares of LGND are up 20.1% year to date.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have improved from $4.43 to $4.44. Shares of ANIP have jumped 17.6% year to date. ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an earnings surprise of 53.90%, on average.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Shutterstock
Bristol Myers (BMY) Gets FDA Nod for Breyanzi Label Expansion
Bristol Myers Squibb (BMY - Free Report) announced that the FDA has granted accelerated approval to the label expansion of chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel).
The regulatory body approved Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Breyanzi is already approved in the United Stated for treating relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy. The therapy was also granted accelerated approval to treat relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines of therapy.
Breyanzi is also approved in Japan, the European Union (EU) and Switzerland for the second-line treatment or relapsed or refractory LBCL, and in Japan, the EU, Switzerland, the U.K. and Canada for relapsed and refractory LBCL after two or more lines of systemic therapy.
About 95.7% of patients responded to Breyanzi in the TRANSCEND FL trial. Responses were rapid and durable with a median time to response of one month and median duration of response not reached. About 80.9% of responders remained in response at 12 months and 77.1% of responders remaining in response at 18 months.
Breyanzi is also now included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for B-cell Lymphomas as a Category 2A recommendation for third-line and subsequent therapy for relapsed or refractory FL.
Breyanzi sales came in at $107 million, up 51% from a year-ago quarter’s tally.
Sales will get a boost with consistent label expansions.
The company’s shares have lost 13.2% year to date compared with the industry's decline of 4.2%.
Image Source: Zacks Investment Research
Last month, the FDA approved a label expansion for BMY’s other CAR T cell therapy Abecma. The therapy is now approved for treating adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
Abecma is already approved in the United States for adult patients with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy.
It is to be noted that Abecma is being jointly developed and commercialized in the United States by Bristol Myers Squibb and 2seventy bio (TSVT - Free Report) . Outside the United States, BMY assumes the sole responsibility for Abecma’s manufacturing and commercialization.
TSVT expects that Abecma’s commercial performance will continue to be impacted by competitive dynamics as 2seventy bio and BMY launch Abecma into the earlier line setting and anticipate a return to growth in the second half of 2024.
However, CAR T cell therapies have been under FDA scrutiny of late. The FDA had earlier asked other companies to add ‘boxed warning’ to the labels of their T-cell immunotherapies.
Bristol Myers Squibb Company Price, Consensus and EPS Surprise
Bristol Myers Squibb Company price-consensus-eps-surprise-chart | Bristol Myers Squibb Company Quote
Approval of new drugs and label expansion of existing ones are important for BMY as the company looks to expand its portfolio. Bristol-Myers’ reported better-than-expected first-quarter results, as adjusted loss was narrower than expected and sales beat estimates. However, the decline in Opdivo sales was a dampener. Revlimid is already facing generic competition and Eliquis, too, is likely to face challenges later.
Zacks Rank & a Stock to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks from the healthcare industry are Ligand Pharmaceuticals (LGND - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While LGND sports a Zacks Rank #1 (Strong Buy), ANIP carries a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 and 2025 earnings per share (EPS) has remained constant at $4.56 and $5.27, respectively. Shares of LGND are up 20.1% year to date.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have improved from $4.43 to $4.44. Shares of ANIP have jumped 17.6% year to date. ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an earnings surprise of 53.90%, on average.