Gentium SpA (fka GENTY)

[surf1944]

I believe the stock could best $2 level after Krystexxa EU approval this year. If the drug fails to gain approval, I believe we will see the stock back under $1.

3. Gentium (GENT), located in Como, Italy, is a biopharmaceutical company focused on the development and manufacture of drugs to treat and prevent a variety of diseases and conditions, including vascular diseases related to cancer and cancer treatments. Defibrotide, the company's lead product candidate, is an investigational drug that has been granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) and Orphan Medicinal Product Designation by the European Medicines Agency, both to treat and to prevent VOD, as well as Fast Track Designation by the U.S. FDA to treat VOD.

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Upcoming EMA catalyst

The company announced on June 21 that it has submitted its responses to the Day 180 List of Outstanding Issues (LoOIs) received from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) with respect to the company's Marketing Authorization Application (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy. Gentium expects to receive an opinion from the CHMP regarding the approval of Defibrotide during the third quarter of 2012.

Veno-occlusive disease is a potentially life-threatening condition, which typically occurs as a significant complication of stem cell transplantation. Certain high-dose conditioning regimens used as part of stem cell transplantation can damage the lining cells of hepatic blood vessels and result in VOD, a blockage of the small veins in the liver that leads to liver failure and can result in significant dysfunction in other organs such as the kidneys and lungs (so-called severe VOD). Stem cell transplantation is a frequently used treatment modality following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children. At present there is no approved agent for the treatment or prevention of VOD in the United States or the European Union.

Financials

The company reported the first-quarter financial results on May 17 with the following highlights:
Revenue $7.5 million
Net loss $1.2 million
Cash $14.2 million

Salvatore Calabrese, SVP & Chief Financial Officer of Gentium commented on May 17:

"We are pleased to report that Defibrotide usage increased by 28% compared to the prior-year period. The company continues to be cash flow positive despite higher expenditures incurred with activities related to expansion of the company's commercial infrastructure and the hiring of contract research organizations and scientific and regulatory consultants to assist and support the FDA and EMA regulatory approval processes."

http://seekingalpha.com/article/832691-5-pharmaceutical-companies-with-ema-or-mhra-catalysts-this-year?source=yahoo