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Bristol (BMY) Label Expansion of Reblozyl Delayed by 3 Months
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Bristol Myers Squibb (BMY - Free Report) announced that the FDA has extended the review of the supplemental biologics license application (sBLA) for Reblozy (luspatercept-aamt).
The sBLA is seeking approval for the treatment of anemia in adults with non-transfusion-dependent (NTD) beta thalassemia. The new target action date is Jun 27, 2022.
Reblozyl, a first-in-class therapeutic option, is currently approved in the United States and European Union to address transfusion-dependent anemia-associated beta thalassemia and lower-risk myelodysplastic syndromes failing an erythropoietin-stimulating agent (ESA) and requiring red blood cell transfusions.
The regulatory body determined a written response to an information request to constitute a major amendment and hence the target action date has been extended by three months to provide time for a full review of the submission.
The sBLA was based on safety and efficacy results from the phase II BEYOND study evaluating Reblozyl plus best supportive care in adults with NTD beta thalassemia. There is an application (Type II variation) also under review by the European Medicines Agency.
We remind investors that Reblozyl is being developed and commercialized by Bristol Myers through a global collaboration with Merck & Co., Inc., (MRK - Free Report) following latter’s acquisition of Acceleron Pharma, Inc. in November 2021.
Reblozyl sales came in at $551 million in 2021 and a label expansion will boost sales further.
Shares of Bristol Myers have rallied 17.6% year to date against the industry’s decline of 13.8%.
Image Source: Zacks Investment Research
On the fourth-quarter earnings call, management stated that it expects approval of three key pipeline candidates in 2022 — mavacamten, deucravacitinib and relatlimab. Each of these assets should generate at least $4 billion of revenues by the end of the decade.
In November, the FDA extended the review of the new drug application (NDA) for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy to Apr 28, 2022.
Key drugs, namely Revlimid and Eliquis, maintain momentum for Bristol Myers. The approval of new drugs adds a revenue stream, which should boost growth in the coming quarters. The pipeline progress is steadily impressive, and strategic collaborations will further expand the portfolio.
However, competition is stiff for Opdivo from the likes of Merck’s Keytruda. Keytruda, approved for various oncology indications, is the key driver for MRK. Revlimid too is likely to face generic competition soon.
The consensus estimate for Vertex’s 2022 earnings has increased $1.13 over the past 60 days to $14.52. Shares of VRTX have gained 9.5% in the past year.
Loss estimates for KLDO have narrowed to $1.64 from $2.13 for 2022 in the past 60 days. Earnings of Kaleido Biosciences surpassed estimates in three of the trailing four quarters and missed the same once.
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Bristol (BMY) Label Expansion of Reblozyl Delayed by 3 Months
Bristol Myers Squibb (BMY - Free Report) announced that the FDA has extended the review of the supplemental biologics license application (sBLA) for Reblozy (luspatercept-aamt).
The sBLA is seeking approval for the treatment of anemia in adults with non-transfusion-dependent (NTD) beta thalassemia. The new target action date is Jun 27, 2022.
Reblozyl, a first-in-class therapeutic option, is currently approved in the United States and European Union to address transfusion-dependent anemia-associated beta thalassemia and lower-risk myelodysplastic syndromes failing an erythropoietin-stimulating agent (ESA) and requiring red blood cell transfusions.
The regulatory body determined a written response to an information request to constitute a major amendment and hence the target action date has been extended by three months to provide time for a full review of the submission.
The sBLA was based on safety and efficacy results from the phase II BEYOND study evaluating Reblozyl plus best supportive care in adults with NTD beta thalassemia. There is an application (Type II variation) also under review by the European Medicines Agency.
We remind investors that Reblozyl is being developed and commercialized by Bristol Myers through a global collaboration with Merck & Co., Inc., (MRK - Free Report) following latter’s acquisition of Acceleron Pharma, Inc. in November 2021.
Reblozyl sales came in at $551 million in 2021 and a label expansion will boost sales further.
Shares of Bristol Myers have rallied 17.6% year to date against the industry’s decline of 13.8%.
Image Source: Zacks Investment Research
On the fourth-quarter earnings call, management stated that it expects approval of three key pipeline candidates in 2022 — mavacamten, deucravacitinib and relatlimab. Each of these assets should generate at least $4 billion of revenues by the end of the decade.
In November, the FDA extended the review of the new drug application (NDA) for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy to Apr 28, 2022.
Key drugs, namely Revlimid and Eliquis, maintain momentum for Bristol Myers. The approval of new drugs adds a revenue stream, which should boost growth in the coming quarters. The pipeline progress is steadily impressive, and strategic collaborations will further expand the portfolio.
However, competition is stiff for Opdivo from the likes of Merck’s Keytruda. Keytruda, approved for various oncology indications, is the key driver for MRK. Revlimid too is likely to face generic competition soon.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the biotech sector are Vertex Pharmaceuticals (VRTX - Free Report) and Kaleido Biosciences , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The consensus estimate for Vertex’s 2022 earnings has increased $1.13 over the past 60 days to $14.52. Shares of VRTX have gained 9.5% in the past year.
Loss estimates for KLDO have narrowed to $1.64 from $2.13 for 2022 in the past 60 days. Earnings of Kaleido Biosciences surpassed estimates in three of the trailing four quarters and missed the same once.