BioCryst plummets on peramivir setback

Shares of BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) fell $0.99 (40%) to $1.46 on Thursday after the company discontinued for futility the Phase III BCX1812-301 trial of peramivir to treat patients hospitalized for serious influenza infection. The discontinuation was based on a pre-planned interim analysis of 119 patients not treated with neuraminidase inhibitors as standard of care (SOC). According to BioCryst, the interim analysis showed only a "small difference" on the primary endpoint of time to clinical resolution between the peramivir plus SOC and the placebo plus SOC arms. The double-blind, international trial enrolled 405 of a planned 600 patients to receive SOC plus once-daily 600 mg IV peramivir or placebo for five days.

BioCryst has not made a final decision, but said the most likely outcome is termination of the peramivir program. The company, which has a two-year $55 million contract extension from HHS to fund the completion of Phase III testing, has received $234.8 million from the agency to fund development of the product. Peramivir, an injectable formulation of a viral neuraminidase ( NEU1; SIAL1) inhibitor, is approved as Rapiacta in Japan. On a conference call to discuss its 3Q12 financial results on Thursday, BioCryst said it will also evaluate operational changes to decrease its cost structure. ...