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Gentium up 46 Percent After Positive News for Defitelio (GENT)

Shares of Gentium S.p.A (NASDAQ: GENT) are up 46 percent after the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for its drug, Defitelio. The committee recommended a Marketing Authorization Application under exceptional circumstances for the treatment of hepatic veno-occlusive disease.

The positive news does not mean that the drug gained approval for sale in Europe. The European Commission will review the opinion and decide if marketing rights should be granted but it often follows the opinion of the committee.

Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A., welcomed the decision saying “We are delighted for this positive recommendation for Defitelio. This outcome from the CHMP meeting is an important milestone for the Company and represents the culmination of a great deal of work by many people. If approved, Defitelio would become the first drug for VOD in the current treatment setting. We look forward to the ratification of the CHMP recommendation by the European Commission.”

[stock-tools exchange="NASDAQ" symbol="GENT" image_height="230" image_width="350"]

Disclosure: At the time of this writing, the author had no position in the company mentioned.

 

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