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Bristol Myers (BMY) Zeposia Gets EC Nod for Ulcerative Colitis
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Bristol Myers Squibb (BMY - Free Report) recently announced the European Commission (“EC”) has approved a label expansion of Zeposia (ozanimod).
The EC granted a marketing authorization to Zeposia for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
Zeposia, an oral medication taken once daily, is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5).
The approval was based on the phase III True North study, which demonstrated clinically meaningful improvements in key clinical, endoscopic and mucosal healing endpoints, with no new safety signals observed.
Zeposia is already approved in this region to treat adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease.
It is also approved in the United States to treat adults with moderately to severely active UC and for the treatment of adults with relapsing forms of multiple sclerosis.
In addition, Bristol Myers is evaluating Zeposia for the treatment of moderately to severely active Crohn’s disease in the ongoing phase III YELLOWSTONE program.
Last month, the company announced that the mid-stage study investigating pipeline candidate deucravacitinib for treating moderate to severe UC has failed.
Shares of the company have lost 7.4% year to date compared with the industry's decline of 16.4%.
Image Source: Zacks Investment Research
The successful development of other drugs will diversify its revenue base.
Earlier in the year, Bristol Myers also obtained FDA approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed CAR T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL).
The company also won FDA approval for Abecma, a first-in-class B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy.
Bristol Myers’ performance has revived of late as Opdivo sales returned to growth after a slowdown. The stellar performance of key drugs, Revlimid and Eliquis, is maintaining the company’s momentum.
However, competition is stiff for Opdivo from the likes of Merck’s (MRK - Free Report) Keytruda. Keytruda, approved for various oncology indications, is the key growth driver for Merck.
The FDA recently approved Keytruda for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence, following nephrectomy, or following nephrectomy and resection of metastatic lesions. Further label expansion of the drug will boost Merck’s top line.
Loss per share estimates for Sarepta have narrowed from $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 30 days. Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.
Loss per share estimates for Viking Therapeutics have narrowed to 74 cents from 81 cents for 2021 and to $1.08 from $1.18 for 2022 in the past 30 days. Viking delivered an earnings surprise of 2.06%, on average, in the last four quarters.
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Bristol Myers (BMY) Zeposia Gets EC Nod for Ulcerative Colitis
Bristol Myers Squibb (BMY - Free Report) recently announced the European Commission (“EC”) has approved a label expansion of Zeposia (ozanimod).
The EC granted a marketing authorization to Zeposia for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
Zeposia, an oral medication taken once daily, is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5).
The approval was based on the phase III True North study, which demonstrated clinically meaningful improvements in key clinical, endoscopic and mucosal healing endpoints, with no new safety signals observed.
Zeposia is already approved in this region to treat adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease.
It is also approved in the United States to treat adults with moderately to severely active UC and for the treatment of adults with relapsing forms of multiple sclerosis.
In addition, Bristol Myers is evaluating Zeposia for the treatment of moderately to severely active Crohn’s disease in the ongoing phase III YELLOWSTONE program.
Last month, the company announced that the mid-stage study investigating pipeline candidate deucravacitinib for treating moderate to severe UC has failed.
Shares of the company have lost 7.4% year to date compared with the industry's decline of 16.4%.
The successful development of other drugs will diversify its revenue base.
Earlier in the year, Bristol Myers also obtained FDA approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed CAR T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL).
The company also won FDA approval for Abecma, a first-in-class B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy.
Bristol Myers’ performance has revived of late as Opdivo sales returned to growth after a slowdown. The stellar performance of key drugs, Revlimid and Eliquis, is maintaining the company’s momentum.
However, competition is stiff for Opdivo from the likes of Merck’s (MRK - Free Report) Keytruda. Keytruda, approved for various oncology indications, is the key growth driver for Merck.
The FDA recently approved Keytruda for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence, following nephrectomy, or following nephrectomy and resection of metastatic lesions. Further label expansion of the drug will boost Merck’s top line.
Zacks Rank and Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Sarepta Therapeutics (SRPT - Free Report) and Viking Therapeutics (VKTX - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Sarepta have narrowed from $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 30 days. Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.
Loss per share estimates for Viking Therapeutics have narrowed to 74 cents from 81 cents for 2021 and to $1.08 from $1.18 for 2022 in the past 30 days. Viking delivered an earnings surprise of 2.06%, on average, in the last four quarters.