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Stock Market & Financial Investment News

News Breaks
August 1, 2013
13:15 EDTBCRXBioCryst gets FDA approval to initiate BCX 4161 trials
BioCryst disclosed in a regulatory filing that on July 31, the company was notified by the United States Food and Drug Administration that the clinical hold placed on its hereditary angioedema drug BCX 4161 has been removed. The FDA notified BioCryst that the complete response submitted by BioCryst to address the clinical hold satisfactorily addressed the FDAs concerns. This notification by the FDA provides BioCryst the ability to initiate BCX 4161 clinical trials in the United States and/or include U.S. clinical sites in its BCX 4161 clinical trials.
News For BCRX From The Last 14 Days
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January 26, 2015
09:56 EDTBCRXBioCryst management to meet with JPMorgan
Meetings to be held in Boston on January 29-30 hosted by JPMorgan.
09:19 EDTBCRXOn The Fly: Pre-market Movers
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06:59 EDTBCRXBioCryst grants fast track designation for BCX4161
BioCryst announced that the FDA has granted Fast Track designation for BCX4161, a novel, orally administered, selective inhibitor of plasma kallikrein in advanced clinical development for the treatment of hereditary angioedema. BioCryst is enrolling HAE patients in the OPuS-2 trial of BCX4161; a double-blind, randomized, placebo controlled trial conducted in the U.S. and certain EU countries, with the goal of demonstrating the efficacy and safety of BCX4161 treatment for 12 weeks in approximately 100 patients with HAE. BioCryst expects to report results from OPuS-2 by the end of 2015.
January 25, 2015
13:57 EDTBCRXUK nurse make full recovery from Ebola, WSJ says
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January 14, 2015
09:16 EDTBCRXOn The Fly: Pre-market Movers
HIGHER: ZIOPHARM (ZIOP), up 53% after the company and Intrexon (XON) announced a licensing agreement with University of Texas. Intrexon shares are also up 12%... GameStop (GME), up 10.6% after reporting holiday SSS, providing guidance for the fourth quarter and fiscal 2014, and being upgraded at Pacific Crest... Smith Micro (SMSI), up 12.7% after reporting preliminary fourth quarter revenue and providing revenue guidance for the first quarter and fiscal 2015... BioCryst (BCRX), up 3.2% after receiving a positive opinion on EMA orphan drug designation for BCX4161... GoPro (GPRO), up 1% following analyst remarks that sell-off after yesterday's report on Apple (AAPL) patent was "overdone." DOWN AFTER EARNINGS: JPMorgan (JPM), down 2.7%... Wells Fargo (WFC), down 2.2%... Banking peers down as well, with Bank of America (BAC) down 2.8% and Citi (C) down 2%. ALSO LOWER: Tesla (TSLA), down 9% following comments made by CEO Elon Musk at an automotive conference in Detroit regarding a slowdown in China... New Media (NEWM), down 4.8% after 7M share spot secondary priced at $21.70... General Motors (GM), down 3% after giving 2015 guidance, saying it is on track to meet previously announced 2016 financial targets... Apple (AAPL), down 1% following lawsuit against Ericsson (ERIC) and countersuit filing.
07:16 EDTBCRXBioCryst receives positive opinion on EMA orphan drug designation for BCX4161
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