ItalyItaly

Gentium shares tank after liver drug is withdrawn

19.08.2011

Como – Shares in Gentium SpA lost about a third of their value on Thursday after The Italian biopharmaceutical company withdrew a marketing application for its drug Defibrotide being used against complications related to stem cell transplantation. "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 CEO Khalid Islam. In their initial review, the FDA had raised concerns regarding the completeness of the datasets for both the treatment and prevention studies. The FDA requested that the Company conduct additional quality reviews of the original datasets and databases. The FDA also requested additional details regarding the conduct and monitoring of the trials by the independent review committee. The market didn't welcome the step. "We have lost confidence in management's abilities to successfully navigate the regulatory and commercial paths for Defibrotide, the company's sole proprietary drug candidate," ThinkEquity analyst Mani Mohindru wrote in a note and downgraded the company's stock to "sell" from "buy." Defibrotide, the Company's lead product candidate, is an investigational drug that has been granted Orphan Drug status and Fast Track Designation by both the FDA as well as the European Commission. In the first quarter 2011, defibrotide net sales as a drug of last resort was 3.86 million euros -- 76 percent of total product sales. Defibrotide is used against veno-occlusive disease (VOD), 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 transplant (SCT) can damage the lining cells of hepatic blood vessels and so result in VOD, a blockage of the small veins of 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).

ItalyItaly

04.11.2010

Rome/Milan – Together with two Italian research institutes, British drug giant Glaxo­SmithKline has begun to develop a therapy for the heriditary immune defect ADA-SCID, which affects only 350 children worldwide. Fondazione...

ItalyItaly

03.11.2010

Rome – When it comes to GMOs, the gap between Italy’s federal government and its regions that has marked the country for years is rapidly widening into a gulf. The latest rupture was on display at the October session of the...

ItalyItaly

18.09.2010

Valletta – A new Life Sciences Park is to be created on the outskirts of Malta’s capital Valletta. The EUR20m project will provide space for companies operating in biotechnology and medical sciences. The park will be located in...

ItalyItaly

17.09.2010

Verona – Scientists at Glaxo­SmithKline in Verona have discovered that specific neurons in the amygdala control how mice react to fear stimuli. When they switched off the so-called Type I cells in the animals’ amyg­dala, the mice...

ItalyItaly

29.08.2010

San Michele all’Adige – The genetic code of the Golden Delicious apple has been deciphered. Led by Riccardo Velasco at the Edmund Mach Foundation in San Michele all’Adige in Italy’s Trentino province, a team of scientists from 20...

ItalyItaly

12.07.2010

: It’s hard to be a pro-GMO campaigner in Italy. Since 2001, the regions there have not implemented the plans for coexistence that were suggested by a ministerial decree. Instead, there was a de facto Italian moratorium on GM...

ItalyItaly

10.07.2010

Milan – One of Italy’s biggest biotech players wants to raise EUR58m to boost its pipeline of cancer therapies. The round will be closed on July 16th. With operating costs of EUR22.5m and a total loss of about EUR17m in 2009,...

ItalyItaly

10.07.2010

Milan – Italian researchers have restored sight to blind patients using stem cells from the patients’ own bodies. In a study published by the New England Journal of Medicine (10.1056/NEJMoa0905955), scientists from Modena and...

ItalyItaly

13.05.2010

Rome/Maryland – The Vatican has taken a bold step into unchartered territory with its decision to finance new research into the potential use of adult stem cells for the treatment of intestinal disease and possibly other...

Displaying results 21 to 30 out of 181

< Previous 21-30 Next >

© 2007-2014 BIOCOM

http://www.european-biotechnology-news.com/nc/news/messages-archive/archive-italy/browse/2/article/gentium-shares-tank-after-liver-drug-is-withdrawn.html

Events

All Events

Stock list

All quotes

TOP

  • 4SC1.17 EUR0.00%
  • ACTELION109.60 CHF0.00%
  • ADDEX3.10 CHF0.00%

FLOP

  • CYTOTOOLS31.45 EUR-0.47%
  • 4SC1.17 EUR0.00%
  • ACTELION109.60 CHF0.00%

TOP

  • CO.DON3.32 EUR32.8%
  • PAION3.05 EUR26.6%
  • EPIGENOMICS3.83 EUR23.2%

FLOP

  • ADDEX3.10 CHF-23.8%
  • EVOTEC3.08 EUR-15.8%
  • MEDIGENE3.93 EUR-14.6%

TOP

  • SANTHERA88.05 CHF2058.1%
  • CO.DON3.32 EUR286.0%
  • PAION3.05 EUR202.0%

FLOP

  • CYTOS0.24 CHF-94.0%
  • BIOFRONTERA2.20 EUR-39.7%
  • MERCK KGAA68.48 EUR-39.7%

No liability assumed, Date: 19.09.2014


Current issue

All issues

Product of the week

Products