Pfizer (NYSE:PFE): Closing price $28.53
On Friday, Pfizer said that the FDA has accepted for review a supplemental new drug application for the Xenjanz (tofacitinib citrate) rheumatoid arthritis indication requesting expansion of the label to include inhibition of progression of structural damage. The agency will review the sNDA and is expected to provide a decision by February next year, based on the anticipated Prescription Drug User Fee Act action date for the sNDA. In November 2012, Xeljanz 5 mg twice daily was approved by the FDA for the treatment of adults having moderately to severely active RA, who saw an inadequate response or intolerance to methotrexate, and is the first approved RA treatment in a new class of medicines that are known as Janus kinase inhibitors.
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