BioCryst 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 FDA’s 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.
BioCryst upgraded to Buy on BCX7353 potential at BofA/Merrill As previously reported, BofA/Merrill upgraded BioCryst to Buy from Neutral and increased its price target to $19 from $12. The firm raised the probability of BCX7353 approval to 40% from 25% given validation of the plasma kallikrein target by both ‘4161 and competitor product and now assign a $13/share value versus near zero previously. BofA/Merrill is now assigning a modest negative value for '4161 versus approximately $7/share previously.