Gentium says CHMP 'unlikely' to recommend defibrotide

Gentium S.p.A. (NASDAQ:GENT) fell as much as 41% on Thursday before closing off $2.46 (21%) to $9.47 after the company said that it expects EMA's CHMP to recommend against approval of an MAA for defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing hematopoietic stem cell transplantation therapy. Gentium said that based on preliminary feedback it is "unlikely" CHMP will change its position before the formal vote on the MAA next month. The company, which could not be reached for details, had submitted responses to two lists of outstanding issues from the committee regarding defibrotide's review. ...