GlaxoSmithKline (NYSE:GSK): Closing price $51.30
On Monday, the FDA okayed Tivicay (dolutegravir), which is a new drug to treat HIV-1 infection. Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. The drug is a pill taken once a day in combination with other antiretroviral drugs. Tivicay is cleared for use in a broad population of HIV-infected patients, and may be used to treat both HIV-infected adults who have never taken HIV therapy and those who have previously taken HIV therapy, including those who have been treated with other integrase strand transfer inhibitors. Beyond that, Tivicay is approved for children ages 12 years and older weighing at least 40 kilograms who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors.
Celldex Therapeutics, Inc. (NASDAQ:CLDX): Closing price $20.36
Celldex Therapeutics has concluded its enrollment in an initial cohort of Avastin (bevacizumab) refractory patients in its ongoing ReACT study of rindopepimut in EGFRvIII (v3)-positive glioblastoma. Based on early evidence of anti-tumor activity, including stable disease, tumor shrinkage and investigator-reported response, Celldex has decided to add an expansion cohort of roughly 75 patients so as to better characterize the potential activity of rindopepimut in this refractory patient population. Enrollment in the expansion cohort has begun and, just as the initial cohort, will examine rindopepimut plus Avastin.
Bristol-Myers Squibb Co. (NYSE:BMY): Closing price $43.11
Bristol-Myers Squibb Canada reports that the Common Drug Review has recommended that its self-injectable subcutaneous formulation of the rheumatoid arthritis treatment Orencia (abatacept) become available for reimbursement via provincial and territorial public drug plans. This action quickly follows the arrival of Orencia SC in Canada, making it the first subcutaneous biologic which is not a TNF agent, and the first biologic available in both intravenous and subcutaneous formulations. The arrival of this new option for the treatment of RA in adults having moderately to severely active rheumatoid arthritis offers patients and physicians a unique choice between formulations.
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