General Commentary: Lightly traded and very cheaply priced Hemispherx Biopharma (HEB) is up sharply today on news that it has reached an agreement with the FDA on the filing requirements for the company's Complete Response in support of its Ampligen New Drug Application for the treatment of chronic fatigue syndrome. The FDA has accepted for review new analyses of data from HEB's AMP-516 Phase 3 clinical trial. Previously, the FDA had recommended at least one additional clinical study including at least 300 patients on dose regimens intended for marketing. Hemispherx frequently sees volatility around any rumors of avian flu due to its product Alferon LDO, which is currently in voluntary clinical trials as a potential treatment.
Gainers on news: Hemispherx Biopharma (HEB +26.8%) FDA agreed to accept for review new analyses of data from the AMP-516 Phase 3 clinical trial in support of its Ampligen NDA Tengion (TNGN +8.87%) Announced continued clinical progress on key milestones for the ongoing Phase 1 trial of its most advanced product candidate, the Neo-Urinary Conduit Orexigen Therapeutics (OREX +4.68%) Announced that The Light Study, the cardiovascular outcomes clinical trial for Contrave, is enrolling faster than originally projected; interim analysis now expected in 2013 Q1Decliners on news: Gilead Sciences (GILD -2.57%) Competitor GlaxoSmithKline (GSK) announced its investigational integrase inhibitor dolutegravir for the treatment of HIV was superior than GILD's Atripla in a Phase 3 trial. Gainers on earnings: No notable gainers on earnings Decliners on earnings: No notable decliners on earnings
Upgrades/Downgrades: Vision-Sciences (VSCI +5.34%) Initiated with a Buy at Lazard, target $3 Mead Johnson Nutrition (MJN +2.02%) Added to Current Better Values List at William Blair HMS Holdings (HMSY -2.63%) Downgraded to Hold from Buy at Jefferies






