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 Label Expansion of Abecma
Read MoreHide Full Article
Bristol Myers Squibb (BMY - Free Report) announced that the FDA approved a label expansion for chimeric antigen receptor (CAR) T cell immunotherapy Abecma. The therapy is now approved for the treatment of 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.
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.
The latest approval, granted on Apr 4, was based on results from the KarMMa-3 trial, wherein Abecma tripled progression-free survival compared to standard regimens, with a 51% reduction in risk of disease progression or death and a well-established safety profile.
The expanded approval brings this personalized CAR T cell therapy to more patients with relapsed or refractory multiple myeloma earlier in their treatment journey as a one-time infusion offering meaningful treatment-free intervals when responding to the therapy.
An approval was mostly expected as the FDA Oncologic Drugs Advisory Committee recently voted in favor (8:3) of Abecma’s benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma.
BMY and TSVT were expecting a decision in December but the FDA delayed and stated that ODAC will meet to review data supporting the application for Abecma.
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.
Abecma was recently approved in Japan, Switzerland and the European Union for adult patients with triple-class exposed relapsed and/or refractory multiple myeloma after two prior lines of therapy.
Abecma’s sales totaled $472 million in 2023, up 22% year over year. Label expansion of the therapy will further boost its sales.
Shares of Bristol Myers have plunged 27.1% in the past year compared with the industry’s decline of 13.5%.
Image Source: Zacks Investment Research
Concurrently, BMY announced new interim results from the phase III EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of investigational muscarinic antipsychotic KarXT (xanomeline-trospium) in adults with schizophrenia.
The results were presented at the Annual Congress of the Schizophrenia International Research Society.
The candidate was added to BMY’s portfolio with the recent acquisition of Karuna Therapeutics.
EMERGENT-4 is a late-stage 52-week, outpatient, open-label extension study evaluating the long-term safety, tolerability and efficacy of KarXT in adults with schizophrenia who previously completed the treatment period in one of the other phase III studies — EMERGENT-2 or EMERGENT-3.
Interim data showed that KarXT was associated with significant improvement in symptoms of schizophrenia across all efficacy measures at 52 weeks. More than 75% of participants achieved >30% improvement in symptoms from baseline, as measured by the Positive and Negative Syndrome Scale (PANSS) total score, at one year. Improvements in symptoms of schizophrenia continued throughout the 52-week trial, regardless of whether participants were previously treated with KarXT or placebo during the acute trials.
In addition, BMY announced interim long-term safety, tolerability and metabolic outcome data from the EMERGENT program. Interim results from pooled, long-term safety studies EMERGENT-4 and EMERGENT-5 showed that KarXT demonstrated a favorable long-term metabolic profile where most patients experienced stability or improvements in metabolic parameters over 52 weeks of treatment. A majority of patients (65%) experienced reductions in weight over the course of the trial, with a mean weight decrease of 2.6kg observed at one year.
Data show no significant changes related to prolactin or clinically meaningful changes in movement disorder scale scores over 52 weeks. KarXT was generally well tolerated, with a side effect profile consistent with prior trials of KarXT in schizophrenia.
Approval of new drugs and label expansion of existing ones are important for BMY as they appear to offset the decline in Revlimid and Eliquis’ revenues.
BMY recently obtained FDA’s accelerated approval for its other CAR T cell therapy, Breyanzi (lisocabtagene maraleucel), for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.
Meanwhile, the FDA also approved Johnson & Johnson’s (JNJ - Free Report) Carvykti (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a PI and an IMiD, and are refractory to lenalidomide. The latest approval makes Carvykti the first and only B-cell maturation antigen-targeted therapy approved for the treatment of patients with multiple myeloma as early as the first relapse.
However, CAR T cell therapies have been under FDA scrutiny of late. The FDA had earlier asked Gilead Sciences, Inc., Johnson & Johnson and Novartis to add “boxed warning” to the labels of their T-cell immunotherapies.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have improved from 22 to 30 cents. In the past year, shares of ADMA have surged 90.9%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met once, delivering an average surprise of 85.00%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Bristol Myers (BMY) Gets FDA Nod for Label Expansion of Abecma
Bristol Myers Squibb (BMY - Free Report) announced that the FDA approved a label expansion for chimeric antigen receptor (CAR) T cell immunotherapy Abecma. The therapy is now approved for the treatment of 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.
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.
The latest approval, granted on Apr 4, was based on results from the KarMMa-3 trial, wherein Abecma tripled progression-free survival compared to standard regimens, with a 51% reduction in risk of disease progression or death and a well-established safety profile.
The expanded approval brings this personalized CAR T cell therapy to more patients with relapsed or refractory multiple myeloma earlier in their treatment journey as a one-time infusion offering meaningful treatment-free intervals when responding to the therapy.
An approval was mostly expected as the FDA Oncologic Drugs Advisory Committee recently voted in favor (8:3) of Abecma’s benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma.
BMY and TSVT were expecting a decision in December but the FDA delayed and stated that ODAC will meet to review data supporting the application for Abecma.
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.
Abecma was recently approved in Japan, Switzerland and the European Union for adult patients with triple-class exposed relapsed and/or refractory multiple myeloma after two prior lines of therapy.
Abecma’s sales totaled $472 million in 2023, up 22% year over year. Label expansion of the therapy will further boost its sales.
Shares of Bristol Myers have plunged 27.1% in the past year compared with the industry’s decline of 13.5%.
Image Source: Zacks Investment Research
Concurrently, BMY announced new interim results from the phase III EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of investigational muscarinic antipsychotic KarXT (xanomeline-trospium) in adults with schizophrenia.
The results were presented at the Annual Congress of the Schizophrenia International Research Society.
The candidate was added to BMY’s portfolio with the recent acquisition of Karuna Therapeutics.
EMERGENT-4 is a late-stage 52-week, outpatient, open-label extension study evaluating the long-term safety, tolerability and efficacy of KarXT in adults with schizophrenia who previously completed the treatment period in one of the other phase III studies — EMERGENT-2 or EMERGENT-3.
Interim data showed that KarXT was associated with significant improvement in symptoms of schizophrenia across all efficacy measures at 52 weeks. More than 75% of participants achieved >30% improvement in symptoms from baseline, as measured by the Positive and Negative Syndrome Scale (PANSS) total score, at one year. Improvements in symptoms of schizophrenia continued throughout the 52-week trial, regardless of whether participants were previously treated with KarXT or placebo during the acute trials.
In addition, BMY announced interim long-term safety, tolerability and metabolic outcome data from the EMERGENT program. Interim results from pooled, long-term safety studies EMERGENT-4 and EMERGENT-5 showed that KarXT demonstrated a favorable long-term metabolic profile where most patients experienced stability or improvements in metabolic parameters over 52 weeks of treatment. A majority of patients (65%) experienced reductions in weight over the course of the trial, with a mean weight decrease of 2.6kg observed at one year.
Data show no significant changes related to prolactin or clinically meaningful changes in movement disorder scale scores over 52 weeks. KarXT was generally well tolerated, with a side effect profile consistent with prior trials of KarXT in schizophrenia.
Approval of new drugs and label expansion of existing ones are important for BMY as they appear to offset the decline in Revlimid and Eliquis’ revenues.
BMY recently obtained FDA’s accelerated approval for its other CAR T cell therapy, Breyanzi (lisocabtagene maraleucel), for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.
Meanwhile, the FDA also approved Johnson & Johnson’s (JNJ - Free Report) Carvykti (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a PI and an IMiD, and are refractory to lenalidomide. The latest approval makes Carvykti the first and only B-cell maturation antigen-targeted therapy approved for the treatment of patients with multiple myeloma as early as the first relapse.
However, CAR T cell therapies have been under FDA scrutiny of late. The FDA had earlier asked Gilead Sciences, Inc., Johnson & Johnson and Novartis to add “boxed warning” to the labels of their T-cell immunotherapies.
Zacks Rank & a Stock to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is ADMA Biologics, Inc. (ADMA - Free Report) , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have improved from 22 to 30 cents. In the past year, shares of ADMA have surged 90.9%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met once, delivering an average surprise of 85.00%.