A bearish article from theStreet.com is pressuring shares of Hemispherx Biopharma (NASDAQ:HEB) Thursday morning, which comes shortly after the company announced a December 20th FDA advisory committee meeting for its lead candidate, Ampligen. As we wrote early this week, and the noted article intones as well, Ampligen, which has been in development for over a decade, has a questionable chance of FDA approval, and Monday’s enthusiastic response from the market was overdone. Shares are off 20% since the rally.
Hemispherx’s New Drug Application for Ampligen, originally submitted in 2007, was rejected by the FDA in 2009 based on poor trial data. At the time, the FDA requested another Phase III trial to support Ampligen as a treatment for Chronic Fatigue Syndrome, but HEB insisted on re-analyzing the existing data. Three years and millions of dollars later, Ampligen is again going before the FDA for the same indication. Slightly unnerving is that Ampligen’s most recent Phase III clinical trial ended in 2004. While the chance of an approval still exists – the FDA has set a February 2013 PDUFA date – holding HEB on expectation of Ampligen’s success is ill-advised.