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Bristol-Myers' Orencia Gets Breakthrough Therapy Tag for GvHD

Bristol-Myers Squibb Company BMY announced that the FDA granted Breakthrough Therapy designation to Orencia (abatacept) for the prevention of moderate-to-severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants (SCT) from unrelated donors. GvHD is a life-threatening medical complication that can impact patients receiving such transplants for the treatment of certain genetic diseases and hematologic cancers. If approved, Orencia will be the first approved therapy for the prevention of acute GvHD.

A potential label expansion of the drug for this indication will boost sales for the company The Breakthrough Therapy designation aims at accelerating the development and review of drugs intended to treat serious or life-threatening diseases.

Shares of the company have gained 13.3% year to date compared with the industry’s growth of 7%.

 

The designation was based on data from a phase II study, in which Orenciawas added to the standard GvHD prophylactic regimen given to patients with hematologic malignancies, who were to receive an SCT from an unrelated donor, increasing the risk of GvHD in these patients.

Notably, the drug is approved in the United States and indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. It is used for the treatment of adults with active psoriatic arthritis. Orencia became the first biologic therapy to gain EU approval specifically for the treatment of methotrexate (MTX)-naïve RA patients with highly active and progressive disease. The drug’s label was expanded in Europe to include psoriatic arthritis as well. 

Bristol-Myers Squibb Company Price

Zacks Rank & Other Stocks to Consider

Bristol-Myers currently carries a Zacks Rank #2 (Buy).

A few other similar-ranked stocks in the same sector are GlaxoSmithKline plc. GSK, Pfizer Inc. PFE and Merck & Co. Inc. MRK. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

GlaxoSmithKline’s earnings per share estimates have increased from $2.98 to $3.17 for 2019 and from $3.01 to $3.10 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 17.23%, on average.

Pfizer’s earnings per share estimates have increased from $2.80 to $2.96 for 2019 and from $2.55 to $2.59 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 8.73%, on average.

Merck’s earnings per share estimates have increased from $4.91 to $5.15 for 2019 and from $5.38 to $5.49 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 12.51%, on average.

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GlaxoSmithKline plc (GSK): Free Stock Analysis Report
 
Merck & Co., Inc. (MRK): Free Stock Analysis Report
 
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Bristol-Myers Squibb Company (BMY): Free Stock Analysis Report
 
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