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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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March 31, 2015
19:38 EDTBCRXOn The Fly: After Hours Movers
HIGHER: Dyax (DYAX), up 47.7% following positive results from Phase 1b clinical trial of DX-2930... Voltari (VLTC), up 93.1% after Carl Icahn reports 52.3% stake... Chesapeake Energy (CHK), up 1.6% after chairman Archie Dunham buys 1M shares of common stock. DOWN AFTER EARNINGS: Cytosorbents (CTSO), down 39.4%... UTi Worldwide (UTIW), down 11.8%... Real Goods Solar (RGSE), down 7%... SYNNEX (SNX), down 3.3%. ALSO LOWER: BioCryst Pharmaceuticals (BCRX), down 8.6% following positive results from Dyax Phase 1b clinical trial of DX-2930... Carpenter Technology (CRS), down 6.4% after targeting a $50M inventory reduction by end of fiscal 2015.
07:00 EDTBCRXBioCryst awarded $35M contract by BARDA for development of BCX4430
BioCryst Pharmaceuticals announced that the Biomedical Advanced Research and Development Authority, or BARDA, within the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, or ASPR, has awarded BioCryst a contract for the continued development of BCX4430 as a potential treatment for diseases caused by RNA pathogens, including filoviruses. This ASPR/BARDA contract includes a base contract of $12.1M to support BCX4430 drug manufacturing, as well as $22.9M in additional development options that can be exercised by the Government, bringing the potential value of the contract to $35.0M. Filoviruses represent serious threats to national security and the U.S. Government has made this a top priority for medical countermeasure development.

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