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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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December 18, 2014
07:21 EDTBCRXBioCryst initiates OPuS-2 clinical trial of BCX4161
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December 15, 2014
07:17 EDTBCRXBioCryst initiates Phase 1 clinical trial of BCX4430
BioCryst Pharmaceuticals announced the dosing of the first subject in a randomized, placebo-controlled Phase 1 clinical trial to evaluate intramuscular, or I.M., administration of BCX4430 in healthy volunteers. BCX4430 is being developed as a potential treatment for hemorrhagic fever viruses, including Ebola virus and Marburg virus disease. The main goals of this first-in-human study are to evaluate the safety, tolerability and pharmacokinetics of escalating doses of BCX4430 administered via I.M. injection in healthy subjects. In part one of the study, subjects will receive a single dose of BCX4430; in part two of the study, subjects will receive BCX4430 for seven days. Up to six single-dose cohorts and four multiple-dose cohorts will be evaluated, with a total of up to 88 volunteers participating.

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