Gentium tanks after it yanks drug app on FDA data concerns

Shares of Italy's Gentium tanked overnight after the drug developer announced that regulators had raised some serious questions regarding the quality of its data for the vascular drug defibrotide. FDA officials had raised a number of "Refuse to File" issues, says Gentium, over the completeness of its datasets, the need for more quality reviews of the data and more information on how trials for the drug were monitored.

Gentium now plans to pull back the application and sort out the regulatory issues before pushing ahead. But investors weren't in a patient mood, and Gentium's shares ($GENT) swiftly plunged more than 25%.

"Given the number of issues raised by the FDA and the short deadline we have to address such issues, we felt that it was appropriate to voluntarily withdraw our NDA submission for defibrotide," said Gentium CEO Khalid Islam. "It is our plan to address these concerns as quickly as possible and to work closely with the FDA to provide an updated and complete NDA."

Investigators had studied defibrotide as a potential new treatment for veno-occlusive disease, damage to small veins that can be triggered by stem cell transplants and lead to liver failure and problems for other organs as well.

- see the Gentium release
- here's the story from Dow Jones

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