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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.
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September 1, 2015
10:51 EDTBCRXBioCryst, ASPR/BARDA amend agreement for development of BCX4430
BioCryst Pharmaceuticals said in a regulatory filing that on August 28, the company and the Biomedical Advanced Research and Development Authority within the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response amended the Agreement dated March 27 for the continued development of BCX4430 as a potential treatment for diseases caused by RNA pathogens, including filoviruses. Pursuant to this amendment, ASPR/BARDA exercised an option under the Agreement to authorize $4.2M of funding to enable non-clinical NDA-enabling toxicology studies and obligated an additional $1.2M of new funding to support previously authorized drug substance and drug product cGMP manufacturing by U.S. suppliers for non-clinical and clinical activities. The execution of the Amendment represents an additional $5.4M in funding BioCryst to support BCX4430 drug manufacturing and toxicology studies, and increases the total potential value of the contract to $36.2M. The period of performance under the exercised options extends through April 14, 2017, while the period of performance under the base period of the contract remains unchanged, extending through September 30, 2016.

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