Gentium falls after pulling defibrotide NDA

Gentium S.p.A. (NASDAQ:GENT) fell $1.94 (22%) to $6.85 on Thursday after withdrawing an NDA for defibrotide because FDA identified numerous issues with the completeness of the dataset for the hepatic veno-occlusive disease (VOD) candidate. Gentium said the agency asked for additional quality reviews of the original data as well as more details about the conduct and monitoring of the trials by the independent review committee. The proposed indication is for VOD in patients undergoing hematopoietic stem-cell transplantation therapy. Details were not disclosed. ...