Hematide problems to delay NDA...

Not necessiarly HCV-related, but ESAs are commonly used in current HCV therapy.  Shares of Affymax Inc. plunged more than 60 percent this morning after the Palo Alto, Calif.-based firm and partner Takeda Pharmaceutical Co. Ltd. reported much-awaited Phase III data for its ESA alternative, Hematide, in chronic renal failure. Though all four trials met the primary endpoint, secondary analyses turned up results that could be problematic, especially for approval in nondialysis patients. The companies will have to conduct further analysis, likely delaying a new drug application, which is good news for Amgen Inc.'s market-leading ESA franchise. Thanks to BioWorld for the scoop.