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Bristol Myers' (BMY) Orencia Gets FDA Nod for New Indication
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Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA has approved its marketed drug, Orencia (abatacept) for yet another indication. The regulatory body has now approved Orencia in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX) for the prevention of acute graft versus host disease or aGvHD in adults and pediatric patients aged two years and above, who are undergoing hematopoietic stem cell transplantation (HSCT) from a matched or one allele-mismatched unrelated donor.
This marks the fourth-approved indication for Orencia in the United States.
The latest FDA approval was based on data from the phase II GVHD-1 study, also known as ABA2, which evaluated the Orencia combo for the given indication as well as the GVHD-2 clinical study using data from the Center for International Blood and Marrow Transplant Research.
Data from the GVHD-1 study showed that treatment with Orencia improved severe aGvHD-free survival in 7/8 mismatched unrelated donor transplant and associated mortality.
Shares of Bristol Myers have decreased 2.3% so far this year compared with the industry’s decline of 22.1%.
Image Source: Zacks Investment Research
We remind investors that Orencia is currently approved in the United States for the treatment of adult patients with moderately to severely active rheumatoid arthritis. The drug is also approved for the treatment of adults with active psoriatic arthritis. Orencia is also indicated for the treatment of moderate-to-severe active polyarticular juvenile idiopathic arthritis (pJIA) in children aged two years and above.
Orencia is approved in the EU for the treatment of MTX-naïve rheumatoid arthritis patients with highly active and progressive disease. The drug is also approved in Europe to treat psoriatic arthritis as well.
In the first nine months of 2021, Orencia generated sales worth $2.4 billion, reflecting an increase of 7% year over year.
Image: Shutterstock
Bristol Myers' (BMY) Orencia Gets FDA Nod for New Indication
Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA has approved its marketed drug, Orencia (abatacept) for yet another indication. The regulatory body has now approved Orencia in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX) for the prevention of acute graft versus host disease or aGvHD in adults and pediatric patients aged two years and above, who are undergoing hematopoietic stem cell transplantation (HSCT) from a matched or one allele-mismatched unrelated donor.
This marks the fourth-approved indication for Orencia in the United States.
The latest FDA approval was based on data from the phase II GVHD-1 study, also known as ABA2, which evaluated the Orencia combo for the given indication as well as the GVHD-2 clinical study using data from the Center for International Blood and Marrow Transplant Research.
Data from the GVHD-1 study showed that treatment with Orencia improved severe aGvHD-free survival in 7/8 mismatched unrelated donor transplant and associated mortality.
Shares of Bristol Myers have decreased 2.3% so far this year compared with the industry’s decline of 22.1%.
We remind investors that Orencia is currently approved in the United States for the treatment of adult patients with moderately to severely active rheumatoid arthritis. The drug is also approved for the treatment of adults with active psoriatic arthritis. Orencia is also indicated for the treatment of moderate-to-severe active polyarticular juvenile idiopathic arthritis (pJIA) in children aged two years and above.
Orencia is approved in the EU for the treatment of MTX-naïve rheumatoid arthritis patients with highly active and progressive disease. The drug is also approved in Europe to treat psoriatic arthritis as well.
In the first nine months of 2021, Orencia generated sales worth $2.4 billion, reflecting an increase of 7% year over year.
Zacks Rank & Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Sarepta Therapeutics, Inc. (SRPT - Free Report) , Editas Medicine, Inc. (EDIT - Free Report) and vTv Therapeutics Inc. (VTVT - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Sarepta Therapeutics have narrowed 28.2% for 2021 and 24.5% for 2022 over the past 60 days.
Earnings of Sarepta Therapeutics surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions.
Loss per share estimates for Editas Medicine have narrowed 11.2% for 2021 and 4.6% for 2022 over the past 60 days.
Editas Medicine’s earnings surpassed estimates in two of the trailing four quarters and missed the same on two occasions.
Loss per share estimates for vTv Therapeutics have narrowed 21.7% for 2021 and 2.9% for 2022 over the past 60 days.
vTv Therapeutics’ earnings surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.