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Bristol Myers (BMY), TSVT Application for Abecma Accepted
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Bristol Myers Squibb (BMY - Free Report) and partner 2seventy bio, Inc. (TSVT - Free Report) announced that the FDA has accepted the companies’ supplemental biologics license application (sBLA) for CAR T cell therapy Abecma (idecabtagene vicleucel).
The regulatory body has set a target action date of Dec 16, 2023.
The sBLA was based on interim results of the phase III KarMMa-3 study, the first and only randomized, controlled study designed to evaluate a CAR T cell therapy in triple-class exposed relapsed and refractory multiple myeloma, in which Abecma significantly reduced the risk of disease progression or death versus standard regimens.
The study enrolled patients who were treated with an immunomodulatory agent, a proteasome inhibitor and daratumumab, which are the commonly used standard treatments in multiple myeloma.
The company is seeking approval of the therapy for earlier lines of treatment.
The European Medicines Agency (EMA) has also validated the Bristol Myers type II variation application for Abecma based on the KarMMa-3 study.
In addition, Japan's Ministry of Health, Labour and Welfare has accepted Bristol Myers Squibb’s new drug application (sNDA) for Abecma based on the KarMMa-3 study.
A potential approval will make this anti-BCMA CAR T cell therapy a standard of care earlier in the treatment course for relapsed and refractory multiple myeloma.
Abecma is being jointly developed and commercialized in the United States by Bristol Myers Squibb and 2seventy bio. The former assumes sole responsibility for Abecma drug product manufacturing and commercialization outside of the U.S.
The development program for Abecma includes ongoing and planned clinical studies (KarMMa-2, KarMMa-3 and KarMMa-9) in earlier lines of treatment for patients with multiple myeloma.
In the past year, BMY’s shares have lost 8.2% compared with the industry’s fall of 11.3%.
Image Source: Zacks Investment Research
In February, BMY 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 and label expansion of existing 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 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.
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 $4.52. Estimates for 2024 have increased 7 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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Bristol Myers (BMY), TSVT Application for Abecma Accepted
Bristol Myers Squibb (BMY - Free Report) and partner 2seventy bio, Inc. (TSVT - Free Report) announced that the FDA has accepted the companies’ supplemental biologics license application (sBLA) for CAR T cell therapy Abecma (idecabtagene vicleucel).
The regulatory body has set a target action date of Dec 16, 2023.
The sBLA was based on interim results of the phase III KarMMa-3 study, the first and only randomized, controlled study designed to evaluate a CAR T cell therapy in triple-class exposed relapsed and refractory multiple myeloma, in which Abecma significantly reduced the risk of disease progression or death versus standard regimens.
The study enrolled patients who were treated with an immunomodulatory agent, a proteasome inhibitor and daratumumab, which are the commonly used standard treatments in multiple myeloma.
The company is seeking approval of the therapy for earlier lines of treatment.
The European Medicines Agency (EMA) has also validated the Bristol Myers type II variation application for Abecma based on the KarMMa-3 study.
In addition, Japan's Ministry of Health, Labour and Welfare has accepted Bristol Myers Squibb’s new drug application (sNDA) for Abecma based on the KarMMa-3 study.
A potential approval will make this anti-BCMA CAR T cell therapy a standard of care earlier in the treatment course for relapsed and refractory multiple myeloma.
Abecma is being jointly developed and commercialized in the United States by Bristol Myers Squibb and 2seventy bio. The former assumes sole responsibility for Abecma drug product manufacturing and commercialization outside of the U.S.
The development program for Abecma includes ongoing and planned clinical studies (KarMMa-2, KarMMa-3 and KarMMa-9) in earlier lines of treatment for patients with multiple myeloma.
In the past year, BMY’s shares have lost 8.2% compared with the industry’s fall of 11.3%.
Image Source: Zacks Investment Research
In February, BMY 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 and label expansion of existing 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 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.
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 $4.52. Estimates for 2024 have increased 7 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.