BioCryst Pharmaceuticals (NASDAQ:BCRX) withdraws its Investigational New Drug application for the antiviral nucleoside BCX5191, subsequent to talks with the FDA, and shares dive on Wednesday, reaching new 52-week lows. Worries over patient safety were cited by the agency, arising from the pre-clinical toxicity profile of the drug at exposure levels which it believes are likely to be necessary to decrease the viral load in patients which are infected with the hepatitis C virus.
GlaxoSmithKline (NYSE:GSK) misses on third quarter revenue and earnings per share as its core operating profit falls by 15 percent to £1.97 billion. Earnings were said to be impacted by “demanding prior year comparisons” along with continued weakness in Europe, where sales dropped 9 percent while price pressure took its toll. Domestic sales decreased by 6 percent, “reflecting genericisation and discontinuation of certain products.”
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Gilead Sciences’ (NASDAQ:GILD) tenofovir alafenamide fumarate treatment for HIV-1 met its primary objective in a Phase II trial in which, in a combo with other drugs, it was up against Stribild, also from Gilead. The medication achieved a similar virological response to Stribild, and the firm now plans to conduct additional studies.
Seattle Genetics (NASDAQ:SGEN) reports that the European Commission has granted conditional marketing authorization to its collaborator, Takeda Pharmaceuticals, for two indications of Adcetris. The first treats adult patients suffering from relapsed or refractory CD30-positive Hodgkin lymphoma, with the second for adult patients with relapsed or refractory systemic anaplastic large cell lymphoma.
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