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Biotech Stocks Facing FDA Decision In December 2021

Bristol Myers Squibb
Bristol Myers Squibb

Bristol-Myers Squibb Co. (BMY) has sought expanded approval for its arthritis drug Orencia in the indication as a preventive therapy for moderate to severe acute graft versus host disease in patients 6 years of age and older receiving unrelated donor hematopoietic stem cell transplantation. The FDA decision is expected on December 23.

Graft versus Host Disease after a hematopoietic stem cell transplant occurs when transplanted donor T-cells recognize antigenic differences between the donor and the recipient and attack the recipient’s healthy tissue and organs.

If approved, Orencia would become the first therapy for the prevention of acute graft versus host disease.

Orencia, administered by subcutaneous injection, is already approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis.

The drug generated sales of $3.2 billion in full year 2020 and $2.4 billion in the nine months ended Sep.30, 2021.

BMY closed Friday’s trading at $56.53, down 0.49%.