Last €0.57 EUR
Change Today +0.007 / 1.25%
Volume 133.8K
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As of 5:45 AM 09/18/14 All times are local (Market data is delayed by at least 15 minutes).

tigenix nv (TIG) Snapshot

Open
€0.57
Previous Close
€0.56
Day High
€0.58
Day Low
€0.56
52 Week High
01/21/14 - €1.03
52 Week Low
09/18/13 - €0.23
Market Cap
91.0M
Average Volume 10 Days
276.5K
EPS TTM
€-0.14
Shares Outstanding
160.5M
EX-Date
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tigenix nv (TIG) Details

TiGenix NV, a biomedical company, develops and commercializes cell therapy products. The company’s stem cell programs are based on a validated platform of allogeneic expanded adipose-derived stem cells (eASC) targeting autoimmune and inflammatory diseases. Its lead product, ChondroCelect, is a cell-based product that is used for cartilage repair in the knee. The company is also involved in developing Cx601, which is in Phase III clinical trial for the treatment of complex perianal fistulas in patients suffering from Crohn’s disease; Cx611, an allogeneic eASC product candidate, which has completed a Phase IIa clinical trial for the treatment of rheumatoid arthritis; and Cx621, an allogeneic eASC product candidate that has completed a Phase I trial for the treatment of autoimmune diseases through intra-lymphatic administration. The company has operations in Belgium, the Netherlands, the United Kingdom, and internationally. TiGenix NV was founded in 2000 and is headquartered in Leuven, Belgium.

56 Employees
Last Reported Date: 03/18/14
Founded in 2000

tigenix nv (TIG) Top Compensated Officers

Chief Executive Officer, Managing Director an...
Total Annual Compensation: €433.6K
Compensation as of Fiscal Year 2013.

tigenix nv (TIG) Key Developments

TiGenix NV Announces Board Appointments

TiGenix NV announced that it has appointed Marie Paule Richard as the company's Chief Medical Officer, and Mary Carmen Diez as its Vice President Medical Affairs and New Product Commercialisation. Richard is an immunologist with more than 25 years experience in the global biopharmaceutical industry, including Chief Medical Officer at Aicuris in Germany; Vice President, Clinical Development, Pharmacovigilance and Medical Affairs at Crucell in Switzerland; and Vice President Vaccines Clinical Development at Sanofi Pasteur in France. Diez, a medical doctor specialised in Internal Medicine and Infectious Diseases, has more than 20 years experience in the biopharmaceutical industry. She joins from Meda Pharma, where she was International Medical Marketing Director for the last nine years. She has been responsible for the preparation and execution of the successful on-time launch of several products at European level. Prior to that, she worked for a number of pharmaceutical companies including Asta Médica, Pfizer and Dupont Pharma.

TiGenix Announces Production Update for the First Half of the Year 2014; Announces Earnings Results for the First Half of the Year 2014

TiGenix NV issued an update on business and financial progress in the first half of the year 2014. eASC technology platform: Patient recruitment for the European Phase III study of Cx601 in complex perianal fistulas in Crohn's disease is 95% complete and is expected to finish ahead of schedule. Final results from the study should now be available earlier than previously expected in third quarter of 2015, and European filing for marketing authorization is planned for the first half 2016. The company confirmed its strategy for developing Cx601 for the US market. The clinical development plans for Cx611 in early rheumatoid arthritis and severe sepsis were completed and implementation has begun. ChondroCelect: The licensing of marketing and distribution rights and the sale of the Dutch manufacturing facility was completed. Marketing authorisation for ChondroCelect was renewed by the European Medicines Agency (EMA). Cx601 phase III trial on track to deliver results in third quarter of 2015; development plans for the US market advancing. The enrolment of patients into the ADMIRE-CD phase III study of Cx601 for complex perianal fistulas in Crohn's disease is 95% complete and is expected to finish ahead of schedule before the end of this year. Study results are expected to be available earlier than previously expected in third quarter of 2015, which should allow TiGenix to file for marketing authorization in Europe during first half 2016. ADMIRE-CD is a multi-centre, randomized, double-blind, placebo-controlled pivotal Phase III trial, which will enrol 278 patients at 52 centres across seven European countries and Israel. TiGenix has made significant progress in clarifying the way forward for Cx601 in the US market, as follows: the Food and Drug Administration (FDA) has confirmed that the ADMIRE-CD Phase III trial, if successful, can serve as supportive evidence for a Biologics Licence Application (BLA); TiGenix is in the process of appointing a contract manufacturing organisation (CMO), and expects to start the technology transfer process to enable production of Cx601 in the US by the end of 2014; TiGenix is appointing a Scientific Advisory Board of clinical experts in the US to provide guidance on the clinical development of Cx601 in the US; by the end of 2014, the company will apply for a Special Protocol Assessment (SPA) from the FDA to ensure that the ADMIRE-CD Phase III study design is aligned with the Agency's requirements for future approval of Cx601. Development plan for Cx611 in early rheumatoid arthritis and in severe sepsis announced having considered the demonstrated therapeutic effects of allogeneic stem cells, the animal and clinical data for Cx611 collected so far, the potential applications in areas of high unmet medical need, and advice from clinical experts in Europe and in the United States, TiGenix will focus the development of its intravenously administered stem cell product, Cx611, in early rheumatoid arthritis and in severe sepsis. The company announced earnings results for the first half of 2014. During the first half of 2014, the operations of TiGenix have been substantially transformed to enable the company to fully focus on realizing the value of its eASC platform and pipeline. The discontinuation of ChondroCelect operations through the licensing of marketing and distribution rights, and the selling of the Dutch manufacturing facility, has changed the presentation of the income statement of the company. Loss for the period for continuing operations was decrease by 2%. The loss for the first six months of 2014, including both continuing and discontinued operations, amounted to EUR 9.2 million, compared to EUR 8.8 million in the same period of 2013. This increase of 4% is the direct result of the loss from discontinued operations and the increase of financial expenses related to the Kreos loan facility. The loss for the period from continuing operations decreased by 2% compared with the same period last year.

TiGenix N.V., H1 2014 Earnings Call, Aug 26, 2014

TiGenix N.V., H1 2014 Earnings Call, Aug 26, 2014

 

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