GENTY Finra deleted symbol:

http://www.otcbb.com/asp/dailylist_detail.asp?d=04/11/2014&mkt_ctg=NON-OTCBB

GENT delisted from Nasdaq to OTC. New ticker GENTY:

http://www.otcbb.com/asp/dailylist_detail.asp?d=03/07/2014&mkt_ctg=NON-OTCBB

7:04AM Gentium: Interim results from Gentium's treatment IND for Defibrotide -- 35% of patients achieved a complete response (CR) and 55% survived to day 100 (D+100) (GENT) 56.79 : Co announced that additional data on Defibrotide were presented this week at the 55th Annual Meeting and Exposition of the American Society of Hematology at the Ernst N. Morial Convention Center in New Orleans, LA, Dec 7-10, 2013.

Professor Paul G. Richardson, RJ Corman Professor of Medicine, Clinical Director Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute Harvard Medical School, Boston, MA (USA) reported, in an oral presentation, the updated results from the ongoing Treatment IND Expanded Access Protocol, a large prospective study on the use of Defibrotide in the treatment of Hepatic Veno-Occlusive Disease in hematopoietic stem cell transplant patients, (abstract # 700). This updated interim analysis was based on 470 patients with VOD, enrolled between Dec 2007 and Dec 2012 at 75 centers across the United States. 425 patients had undergone hematopoietic stem cell transplant and of those patients, 35% of patients achieved a complete response (CR) and 55% survived to day 100 (D+100).

Additional findings were as follows: In the subgroup of 284 HSCT patients with severe VOD, 29% achieved a CR and 48% survived to day 100. In the sub-group of 141 HSCT patients with non-severe VOD, 47% achieved a CR and 69 % survived to D+100. In the subgroup of 45 patients who had VOD following chemotherapy but no HSCT, 40% achieved a CR and 62% survived to D+100. Delayed initiation of Defibrotide treatment (more than 2 days after VOD diagnosis) resulted in reduced CR (25% versus 39%, p=0.0052) and survival (38% versus 61%, p=0.0001) compared to early administration (within 2 days from VOD diagnosis).

7:02AM Gentium announces successful completion of Defibrotide Phase 1 study in Japan; no serious adverse events were noted (GENT) 47.92 : Co announced that the medical team from the Phase 1 Trial Unit of the Translational Research Center at the National University Corporation, Hamamatsu University School of Medicine, Fukushima Medical University has successfully completed the phase 1 clinical study to evaluate the Safety and Pharmacokinetics of Defibrotide (DF) in Healthy Adults. This Investigator led clinical trial was adopted as a Health and Labour Sciences Research Grant in 2012 for Practical Use of Medical Technology. The primary objective of the study was to evaluate the safety and pharmacokinetics of defibrotide in healthy Japanese adult subjects. The secondary objective was to evaluate the effect of defibrotide on the coagulation and fibrinolytic systems in vivo. Two dose levels (3 mg/kg and 6.25 mg/kg, termed Cohort 1 and Cohort 2, respectively) were evaluated, each cohort consisted of 10 subjects (8 subjects were given DF, 2 were given placebo).

All 20 subjects completed the protocol defined treatment and there were no premature discontinuations. No serious adverse events were noted and only one mild, transient and reversible adverse event observed. Moreover, no clinically significant changes were observed in laboratory test results in any of the dosing groups.

true GENTleman running this stock up! sick chart

This one continues to move strong with a very solid chart. I will keep trading this one until it goes up at least another 30%.

http://seekingalpha.com/article/1796902-gentium-posts-strong-q3-beat-and-remains-attractive?source=google_news

6:12AM Gentium receives Marketing Authorization from the European Commission for Defitelio (GENT) 29.59 : Co announced that the European Commission has granted a Marketing Authorization for Defitelio (defibrotide) for the treatment of severe hepatic veno-occlusive disease ("VOD") in adults and children undergoing hematopoietic stem cell transplantation therapy. Defitelio is the first approved treatment in the European Union for this lcondition. This authorization is the formal endorsement of the positive opinion received from the European Medicine Agency's Committee for Human Medicinal Producton July 26, 2013. The Company intends to begin commercialization of Defitelio in the European Union in December 2013.

Big news!

so with news like this today how far could this go? Seems like its getting up there. Great news like this I would think would bring with it profit takers. Could it be a possible short for a few days that is the question I'll be pondering. Any input appreciated.

6:01AM Gentium files documentation requesting a Re-examination of the negative opinion given by the EMA's CHMP regarding the MAA for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy (GENT) 8.30 : co announced that it has filed the documentation requesting a Re-examination of the negative opinion given by the European Medicines Agency's Committee for Medicinal Products for Human Use regarding the Marketing Authorisation for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. In accordance with European regulations, the CHMP has 60 days to consider a revision of the initial opinion and consequently a final recommendation may be made by the end of July.

6:30AM Gentium to request re-examination of CHMP opinion on Defibrotide (GENT) 7.70 : Co announced that it has requested a re-examination of the negative opinion adopted, by the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP"), on March 22nd, regarding the Marketing Authorisation submitted for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. In accordance with European regulations, the Company has 60 days to submit grounds for appeal and the CHMP has further 60 days to consider a revision of the initial opinion. The appeal involves a re-examination of the original MAA and must be based on the data already submitted. Notwithstanding the CHMP's negative opinion, Gentium remains convinced of the favourable benefit/risk profile of Defibrotide, which is the only option recommended by the European Group for Blood and Marrow Transplantation for the treatment VOD.

8:34AM Gentium receives negative opinion from the CHMP on Defibrotide for the treatment and prevention of VOD (GENT) 8.13 : Co announced that it has been informed by the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") that it has adopted a negative opinion, recommending the refusal of the marketing authorization for Defibrotide to treat and prevent hepatic veno-occlusive disease ("VOD") in adults and children undergoing hematopoietic stem cell transplantation therapy. Gentium remains convinced of the favourable benefit/risk profile of Defibrotide, which is the only option recommended by the European Group for Blood and Marrow Transplantation for the treatment VOD, an unmet medical need where no agents are currently approved. In accordance with European regulations, the Company plans to appeal the EMA's decision and request a re-examination of the CHMP opinion. EU patients will continue to have access to Defibrotide, under a named patient program where available.

7:01AM Gentium provides update on the review of Defibrotide Marketing Authorization; co expects an opinion recommending against approval of the Marketing Authorization Application for Defibrotide (GENT) 11.93 : Co had presented an oral explanation at the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") as part of its Marketing Authorization Application ("MAA") for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. Following the oral explanation, based on preliminary feedback from the EMA's CHMP, the co expects an opinion recommending against approval of the MAA for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. While not a final decision, the Company considers it unlikely that this position will change before the formal vote is undertaken next month. If a formal negative recommendation is issued, and depending upon the nature of the objections, the Company may appeal such negative decision.

Answered my own question. Per the EMA website, expect meeting results to be published 22 Feb.

GLTA,

Murocman

Would it be reasonable to expect an immediate decision or is it typical for there to be a delay?

TIA,

Murocman

7:03AM Gentium Provides an Update on Defibrotide MAA to EMA; MAA will be on the agenda for discussion at the EMA CHMP meetings scheduled to be held on February 18-21, 2013 (GENT) 11.59 : Co announced that it has been informed that the Company's Marketing Authorization Application for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing haematopoietic stem cell transplantation therapy will be on the agenda for discussion at the European Medicines Agency's Committee for Medicinal Products for Human Use meetings scheduled to be held on February 18-21, 2013.

7:01AM Gentium reports results from its treatment IND for Defibrotide Presented at the American Society of Hematology Annual Meeting; In the subgroup of HSCT patients with sVOD, 26% achieved a CR and 45% survived to day 100 (GENT) 11.80 : Co announced that additional data from ongoing trials of Defibrotide were presented this week at the 54th Annual Meeting and Exposition of the American Society of Hematology (ASH) held at the Georgia World Congress Center in Atlanta, Georgia. Dr. Paul Richardson, Clinical Director of the Dana-Farber Cancer Institute, Boston, MA (USA), reported in an oral presentation the updated results of a large prospective study on the use of Defibrotide in the treatment of Hepatic Veno-Occlusive Disease (VOD) in hematopoietic stem cell transplant patients, from the ongoing Treatment IND Expanded Access Protocol.

The interim analysis was based on 333 patients with severe veno-occlusive disease (sVOD) and multi-organ failure (MOF), enrolled between December 2007 and September 2011 at 68 centers across the United States. 305 patients had undergone hematopoietic stem cell transplant (HSCT) and of those patients, 30% of patients achieved a complete response (CR) and 50% survived to day 100 (D+100). Additional findings were as follows:

In the subgroup of HSCT patients with sVOD, 26% achieved a CR and 45% survived to day 100. In patients with non-severe VOD, 39% achieved a CR and 65 % survived to D+100.
In the Treatment IND, 155 patients matched the entry criteria for the original Phase 3 trial and comparison to the Phase 3 historical controls showed a statistically improved outcome in CR (29% vs 9%, p=0.0019) and D+100 survival (49% vs 25%, p=0.0016)
Delayed initiation of Defibrotide treatment (>2 days, versus a delay of <2 days) following VOD diagnosis resulted in reduced CR (20% versus 34%, p=0.0195) and survival (37% versus 56%, p=0.0118). CR rate and D+100 survival for the 69 patients with non-severe VOD were 42% and 62%, respectively.
Children younger than 16 years old had higher CR rates than adults (33% vs 26%, p=0.187) and survival (56% vs 44%, p=0.277).

7:18AM On The Wires (WIRES) :Gentium S.p.A. (GENT) announced the co's entry into an agreement with the National University Corporation Hamamatsu University School of Medicine, Fukushima Medical University and LINK Healthcare to support a clinical trial to evaluate the safety and pharmacokinetics of Defibrotide in healthy adults.

7:31AM Gentium receives second list of outstanding issues from the EMA's CHMP for Defibrotide MAA (GENT) 10.55 : Co announced that it has received a second List of Outstanding Issues from the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use in connection with the Company's Marketing Authorization Application for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing haematopoietic stem cell transplantation therapy. The second LoOIs has reset the EMA's approval timetable back to Day 180. The Company plans to submit its response to the LoOIs within 60 days, in line with the new regulatory timetable. A recommendation on the approval of Defibrotide is now expected in early Q1 2013, based on the EMA review process timeline.

Gentium Provides Update on the Review of Defibrotide Marketing Authorization Application
GlobeNewswirePress Release: Gentium S.p.A. – 1 hour 1 minute

VILLA GUARDIA, Italy, Sept. 26, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (GENT) (the "Company") today announced that, following the Company's presentation of Oral Explanations to the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") on September 19, 2012, the CHMP has decided to adopt a second List of Outstanding Issues ("LoOI") relating 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. Defibrotide was designated as an orphan drug product in the European Union on July 29, 2004 for the treatment and prevention of VOD.

Dr. Khalid Islam, Chairman and CEO of the Company, commented that "Gentium is committed to obtaining approval of this potentially life-saving treatment for VOD, a condition with a mortality rate of greater than 80% and for which there is currently no approved treatment."

The Company continues to engage in an ongoing dialogue with the rapporteurs in the final stages of the application review process. The Company expects the CHMP to render a final decision on the Defibrotide MAA in the coming months.

About the EMA Review Process:

More information can be obtained from the EMA website www.ema.europa.eu.

About VOD

Veno-occlusive disease (VOD) 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.

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.

(click to enlarge)

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

7:31AM Gentium submits day 180 response to list of outstanding issues received from the EMA's CHMP for Defibrotide MAA (GENT) 9.40 : Co announced that it has submitted its responses to the Day 180 List of Outstanding Issues received from the European Medicines Agency's Committee for Medicinal Products for Human Use with respect to the Company's Marketing Authorization Application for Defibrotide to treat and prevent hepatic veno-occlusive disease 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. If the written responses satisfy the questions raised in the LoOIs and the CHMP does not require any further explanation or clarification, a recommendation regarding the approval of Defibrotide could be issued by the CHMP as early as the third quarter of 2012.

GENT CHMP news today

Gentium Receives Day 180 List of Outstanding Issues From the CHMP for Defibrotide MAA
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Gentium S.p.A. (Nasdaq:GENT) (the "Company") announced today that it has received the Day 180 List of Outstanding Issues (the "LoOIs") from the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") in connection with 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.

The Company plans to submit its responses to the LoOls within 60 days, in line with the regulatory timetable. If the written responses satisfy the issues raised in the LoOIs and the CHMP does not require further explanation or clarification, a recommendation on the approval of Defibrotide could be made as early as the third quarter of 2012. If oral explanations are required, a clock stop may be imposed. The CHMP is expected to reach its final opinion no later than Day 210, based on the EMA review process timeline.

"We believe we have made good progress in working with the E.U. Rapporteurs to address the issues raised in their Day 120 List of Questions," said Dr. Khalid Islam, Chairman & Chief Executive Officer of the Company. "We plan to continue working closely with the EMA towards the approval of Defibrotide and to resolve any remaining open issues."

About the EMA Review Process:

EMA guidelines permit companies in receipt of LoOIs to respond within one month. More information can be obtained from the EMA website www.ema.europa.eu.

About VOD

Veno-occlusive disease (VOD) 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.

About Gentium

Gentium S.p.A., 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.

The Gentium S.p.A. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=12669

7:51AM On The Wires (WIRES) :Gentium (GENT) announced the appointment of PharmaSwiss, a division of Valeant Pharmaceuticals International (VRX) as the exclusive distributor of Defibrotide for 10 years in Albania, Bosnia, Bulgaria, Croatia, Cyprus, Czech Republic, Greece, Hungary, Macedonia, Montenegro, Poland, Romania, Serbia, Slovenia and Slovakia.

Thanks a bunch, This is from rough, fairly accurate unconfirmed data.

Actually the earnings release and conference call are Tuesday the 27th 8am conference call.

http://investor.shareholder.com/gentium/eventdetail.cfm?eventid=111014

~ Monday! $GENT ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $GENT ~ Earnings expected on Monday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.








http://stockcharts.com/h-sc/ui?s=GENT&p=D&b=3&g=0&id=p88783918276&a=237480049




http://stockcharts.com/h-sc/ui?s=GENT&p=W&b=3&g=0&id=p54550695994



~ Google Finance: http://www.google.com/finance?q=GENT
~ Google Fin Options: hhttp://www.google.com/finance/option_chain?q=GENT#
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~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=GENT
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<<<<<< http://www.earningswhispers.com/stocks.asp?symbol=GENT >>>>>>



http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916

*If the earnings date is in error please ignore error. I do my best.

Here is a link to a Medscape story on the Lancet data presentation

I think you need to be a member to see this (it was free when I signed up years ago)
http://www.medscape.com/viewarticle/759098

Defibrotide for prophylaxis of hepatic veno-occlusive disease in paediatric haemopoietic stem-cell transplantation: an open-label, phase 3, randomised controlled trial

I am not a subscriber so can only see the abstract.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)61938-7/fulltext#article_upsell

7:35AM Gentium responds to the EMA's Day 120 List of Questions for Defibrotide MAA; says ' we have finalized and submitted written responses to the LoQs' (GENT) 8.58 : Co announced that it has submitted its response to the Day 120 List of Questions issued by the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") with respect to the Company's Marketing Authorization Application for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy. "Following the submission of the Day 120 LoQs responses, the CHMP will continue its review of the MAA and will either issue an opinion on the MAA or submit a List of Outstanding Issues (LoOIs) requiring further clarification, the latter of which will stop the review clock to permit the Company time to respond. The CHMP is expected to reach its final opinion no later than day 210 calculated based on the EMA review process timeline."

Up $1.50 t0 $7.10..

Gentium Appoints Swedish Orphan Biovitrum AB as Exclusive Distributor of Defibrotide in Nordic and Baltic Territories
Press Release: Gentium S.p.A. – Mon, Jan 9, 2012 7:30 AM EST

Companies:

* Gentium S.p.A
* Swedish Orphan Biovitrum AB

RELATED QUOTES
Symbol Price Change
GENT 7.10 +1.38

VILLA GUARDIA (COMO), Italy, Jan. 9, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT - News) announced the appointment of the Swedish Orphan Biovitrum A.B., (Sobi) (Stockholm:SOBI.ST - News) as the exclusive distributor of Defibrotide in the following territories: Sweden, Denmark, Norway, Iceland, Finland, Latvia, Lithuania and Estonia. Under the terms of the agreement, which is valid for 10 years, Sobi will be responsible for managing named-patient requests and achieving price and reimbursement approvals in these territories. Following regulatory approval to market Defibrotide, if any, Sobi will be responsible for sales, marketing and local medical affairs activities in the territories.

Commenting on the appointment of Sobi, Adrian Haigh, Senior Vice President of Commercial Operations at Gentium S.p.A. said, "We are pleased to have established a long-term relationship with Sobi for the Nordic and Baltic territories, which is consistent with our overall commercial strategy to partner with strong local distributors. Sobi has unparalleled experience in managing orphan drugs and an established expertise in the area of stem cell transplantation."

"We are looking forward to the partnership with Gentium and the growth potential that Defibrotide will add to our specialty distribution portfolio. In addition, Defibrotide has a strong strategic fit with our current hematology portfolio, in particular with Kepivance(R), targeting patients undergoing stem-cell transplantation," said Anders Edvell, VP, Marketing & Sales at Sobi.

About VOD

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 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). SCT is a frequently used treatment modality following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children. There is currently no approved agent for the treatment or prevention of VOD in the US or the EU.

About Defibrotide

Defibrotide has the potential to become the first drug approved for the prevention and treatment of hepatic veno-occlusive disease (VOD) a serious and potentially fatal complication of hematopoietic stem-cell transplantation (HSCT). The efficacy of Defibrotide to treat hepatic VOD in HSCT patients is supported by data from a multi-center Phase 3 historically controlled trial, evaluating Defibrotide for the treatment of severe VOD (patients with VOD and multi-organ failure), a Phase 2 dose finding study, and interim data reported from the ongoing Phase 3 expanded access U.S. Treatment IND program in patients with severe hepatic VOD. Additional data include a Phase 3 randomized controlled study of Defibrotide in the prevention of hepatic VOD in pediatric HSCT patients. Defibrotide has generally been well-tolerated in the clinical setting, and results in more than 1,300 patients to date have shown that generally Defibrotide does not appear to increase the risk of complications in HSCT patients.

About Gentium

Gentium S.p.A., 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. FDA and Orphan Medicinal Product Designation by the European Commission both to treat and to prevent VOD and Fast Track Designation by the U.S. FDA to treat VOD. Gentium submitted the MAA for Defibrotide to the EMA in May 2011 and the CHMP issued the 120 day List of Questions in September 2011. Gentium anticipates responding to these questions during the first quarter of 2012. The CHMP review of the MAA will resume with Day 121 on receipt of Gentium's responses.

About Swedish Orphan Biovitrum (Sobi)

Swedish Orphan Biovitrum (Sobi) is a leading integrated biopharmaceutical company dedicated to bringing innovative therapies and services to improve the health of rare disease patients and their families. The company has three business lines: a core product portfolio including 5 proprietary medicines in the core therapeutic areas of Inflammation and Genetics & Metabolism, a Specialty Distribution Portfolio of 50 marketed products, and a GMP biologics facility. Sobi has three protein therapy projects in late stage clinical development -- Kiobrina, an enzyme replacement therapy to prevent growth restriction of prematurity in infants, and long acting coagulation factors 8 and 9 for Hemophilia A and B in collaboration with Biogen Idec. In 2010 Sobi had revenues of SEK 1.9 billion and 500 employees. The share (Stockholm:SOBI.ST - News) is listed on OMX NASDAQ Stockholm. More information is available at www.sobi.com.

http://quotes.barrons.com/gent/ownership

7:34AM Gentium provides update on MAA for Defibrotide (GENT) 6.32 : Co provided an update on the European Marketing Authorization Application for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem-cell transplantation therapy. The co has received and reviewed the Day 120 List of Questions from the European Medicines Agency's Committee for Medical Products for Human Use and anticipates that it will submit its responses by the end of December. Gentium submitted the MAA for Defibrotide to the EMA in May 2011 and the CHMP issued the LoQs at the end of September 2011, following the initial accelerated review of the Defibrotide registration dossier. Gentium has informed the CHMP that it intends to submit responses before year-end, within the EMA's standard three month response time frame for LoQs. The CHMP review of the MAA will resume with Day 121 upon submission of Gentium's response. Following this review period, Gentium expects to respond to any further questions during the first quarter of 2012, at which point the timeline to finalize the process will be made clearer.

October 20, 2011 07:36 EDT Gentium provides update on MAA process for defibrotide in Europe

Gentium provided an update on the European Marketing Authorization Application for Defibrotide, the MAA, to treat and prevent hepatic veno-occlusive disease, VOD, in adults and children undergoing haematopoietic stem-cell transplantation therapy. The Company has received and reviewed the Day 120 List of Questions (LoQs) from the European Medicines Agency's (the "EMA") Committee for Medical Products for Human Use (the "CHMP") and anticipates that it will submit its responses by the end of December. (GENT)

Total Cash (mrq): 13.38M
Total Cash Per Share (mrq): 0.89
Total Debt (mrq): 3.86M
Total Debt/Equity (mrq): 18.43
Current Ratio (mrq): 1.94
Book Value Per Share (mrq): 1.40

secondary likely coming before end of year

Gentium Reports First Half 2011 Financial Results


Related Quotes
Symbol Price Change
GENT 6.45 0.00

Press Release Source: Gentium S.p.A. On Tuesday September 20, 2011, 7:00 am EDT

* Cash flow positive and stronger cash position
* Defibrotide product sales increased by 25%
* Net income of EUR 2.67 million (US$ 3.85 million) for the first half of 2011
* Decrease in API revenues related to a health authority imposed price adjustment; revised product sales guidance for 2011 to EUR 21-23 million

VILLA GUARDIA (COMO), Italy, Sept. 20, 2011 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT - News) (the "Company") today reported financial results for the first half of 2011 and the quarter ended June 30, 2011. The Company reports its financial and operating results using U.S. Generally Accepted Accounting Principles (GAAP). The Company's financial statements are prepared using the Euro as its functional currency. On June 30, 2011, EUR 1.00 = $1.44.

"We are pleased to report that Defibrotide product sales increased 25% compared with the prior-year period," stated Salvatore Calabrese, Senior Vice President and Chief Financial Officer of Gentium S.p.A. "Additionally, we have continued to be cash flow positive and profitable during the first half of 2011, and have decreased our long-term debt while investing in the establishment of our European sales infrastructure. We confirm our previously reported projection that Defibrotide product sales for 2011 are expected to increase 25%-30% over 2010, but due in large part to lower API revenues, we are revising our 2011 product sales forecast to be in the range of EUR 21-23 million instead of EUR 23--25 million as originally projected."

"We are delighted that the number of clinics using Defibrotide through the expanded access and named-patients programs has increased since the beginning of the year, and we have entered into new local distribution agreements with several specialized regional partners that will initially distribute Defibrotide through these programs," stated Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A. "Our Marketing Authorization Application (MAA) for Defibrotide was accepted by the European Medicines Agency (EMA) and we expect to receive any questions on the application shortly. With regard to the United States, we recently announced that we voluntarily withdrew our New Drug Application (NDA) for Defibrotide with the U.S. Food and Drug Administration (FDA) in order to conduct additional quality reviews on our original datasets and databases. An independent clinical research organization specialized in this area has been engaged to review all the datasets and identify the issues. Once that process is complete, we intend to prepare a remediation plan and discuss it with the FDA to determine if it satisfactorily addresses the Agency's concerns."

GENT $6.00 Gentium shares tumble after co withdraws liver drug




By Shravya Jain

Thu Aug 18, 2011 10:40am EDT

(Reuters) - Shares of Gentium SpA (GENT.O) fell as much as 30 percent on Thursday, a day after it withdrew a marketing application for its experimental treatment for life-threatening complications related to stem cell transplantation.

"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."

Gentium is testing defibrotide as both preventive and acute treatment options for veno-occlusive disease, a condition in which small veins of the liver are blocked, in stem cell transplant patients.

The U.S. Food and Drug Administration raised concerns about the completeness of the datasets for both the treatment and prevention studies.

Mohindru said she had been expecting the issues to be debated by an advisory panel.

"Contrary to our expectations, the clinical deficiencies were apparently so serious, that the FDA did not even want to spend time to review the entire application," she wrote.

However, Wedbush Securities analyst Gregory Wade said he was confident in the drug's ability to get approved both in the United States and Europe and would be an aggressive buyer of the company's shares based on weakness.

He cut the price target on the stock by $2 to $14.

He said the product remained the standard of care both in the United States and Europe and that hasn't changed.

In the first quarter, defibrotide net sales to patients who have unsuccessfully used all alternate treatment options was 3.86 million euros -- 76 percent of total product sales.

"While there may be a bump in the road to approval, it is not really affecting the business of the company in the near-term at least," he said.

The Italian company's shares were trading down 29 percent at $6.22 on Thursday morning on Nasdaq.

(Reporting by Shravya Jain in Bangalore; Editing by Joyjeet Das)

Gentium announces NDA submission for Defibrotide
theflyonthewall

On Wednesday July 6, 2011, 7:35 am EDT

Gentium S.p.A. announced that it has submitted a New Drug Application, NDA, to the United States Food and Drug Administration, FDA, for Defibrotide for the treatment of hepatic veno-occlusive disease, VOD, in adults and children undergoing hematopoietic stem-cell transplantation, HSCT.

7:32AM Gentium announces MAA for defibrotide accepted by EMA and will be reviewed by CHMP under accelerated assessment (GENT) 9.98 : Co announces that its Marketing Authorization Application seeking approval of Defibrotide for the prevention and treatment of hepatic veno-occlusive disease following stem-cell transplantation has been accepted for review by the European Medicines Agency. Acceptance of the MAA indicates that the application is complete and initiates the regulatory review process by the Committee for Medicinal Products for Human Use. CHMP has agreed to the co's request for an accelerated assessment of the MAA. Under accelerated assessment, the review timeline of the MAA is shortened from 210 to 150 days.

http://www.nasdaq.com/aspxcontent/newsheadlines.aspx?symbol=GENT&selected=GENT&SourceCode=PMZ

http://www.nasdaq.com/asp/holdings.asp?symbol=GENT&selected=GENT&FormType=Institutional

10 Stocks Under $10 With Upside

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Gentium GENT Wedbush Outperform $16

http://www.briefing.com/Investor/Public/Calendars/UpgradesDowngrades.htm

Gentium Announces Presentation of Preclinical and Clinical Data on Defibrotide at the 33rd World Congress of International Society of Hematology

http://finance.yahoo.com/news/Gentium-Announces-prnews-3270290902.html?x=0&.v=1

Gentium Reports First Half 2010 Financial Results

http://finance.yahoo.com/news/Gentium-Reports-First-Half-prnews-4031723771.html?x=0&.v=1

Gentium to Review First Half 2010 Financial Results
Conference Call and Webcast on Thursday August 12, 2010

http://finance.yahoo.com/news/Gentium-to-Review-First-Half-prnews-3425373818.html?x=0&.v=1

surf,

I am new to this stock. Why is it rising? Great earnings expectation? And do you think it will break the 52week high?

Thanks

http://investor.shareholder.com/gentium/releases.cfm

http://www.nasdaq.com/asp/quotes_sec.asp?symbol=GENT&selected=GENT

http://www.dailyfinance.com/company/gentium-spa-ads-represents-ordinary-shares/gent/nas/institutional-ownership