logo
  Join        Login             Stock Quote

Gentium (GENT) Issues Update On Defibrotide, Shares Plunge

 February 21, 2013 08:01 AM
 


(By Balachander) Gentium S.p.A. (NASDAQ: GENT) tumbled nearly 39 percent in premarket trading on Wednesday after the Italian biopharmaceutical company provided an update on the review of marketing authorization for its lead product candidate to treat hepatic veno-occlusive disease (VOD).

Gentium said it expects an opinion recommending against approval of the Marketing Authorization Application for Defibrotide from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

"While not a final decision, the company considers it unlikely that this position will change before the formal vote is undertaken next month," the company said. "If a formal negative recommendation is issued, and depending upon the nature of the objections, the company may appeal such negative decision."

[Related -Stocks Fall On Mixed Data; Tesla Motors (TSLA) Drops]

VOD is a disease of the liver in which the small vessels are destroyed. This can occur following liver transplantation but also as an adverse reaction to certain medicines. VOD typically occurs as a significant complication of stem cell transplantation.

Currently, there is no approved agent to treat or prevent VOD in the United States or the European Union. Orphan designation of Defibrotide was granted in the United States for the treatment of hepatic VOD.

"We will work closely with the CHMP to address the Committee's concerns and remain confident of the favorable benefit/risk profile of Defibrotide, which is the only option recommended by the European Group for Blood and Marrow Transplantation for the treatment of VOD," Gentium said.

[Related -Futures Drop After Fed Minutes; Tesla Motors (TSLA) Retreats]

ADRs of GENT, which have been trading in the 52-week range of $7.70 to $12.84, ended at $11.93 on Wednesday.

iOnTheMarket Premium
Advertisement

Advertisement


Post Comment -- Login is required to post message
Name:  
Alert for new comments:
Your email:
Your Website:
Title:
Comments:
 

rss feed

Latest Stories

article imageRussell 2000 Showing Relative Weakness at the New Highs

A quick “Quad Index” Grid shows us that the small-cap Russell 2000 is showing relative strength to the read on...

article imageThe Poster Boy For Liberal Economics Discovers The Tax Factor

Paul Krugman seems to be having a supply-side-economics moment… sort of. Raising taxes, the NY Times read on...

article imageMacroprudential Policy And Distribution Of Risk

There is very little doubt that housing prices and leverage played a strong role in the global financial read on...

article imageIs the World Turning Japanese?

Many really think so, but reality suggests read on...

Advertisement
Popular Articles

Advertisement
Daily Sector Scan
Partner Center



Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.