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Last €9.67 EUR
Change Today -0.33 / -3.30%
Volume 221.2K
TXCL On Other Exchanges
EN Paris
As of 10:14 AM 08/4/15 All times are local (Market data is delayed by at least 15 minutes).

txcell (TXCL) Snapshot

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08/3/15 - €10.65
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10/16/14 - €4.70
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txcell (TXCL) Details

TxCell S.A., a biotechnology company, develops T cell immunotherapies using antigen specific regulatory T-cells for severe chronic inflammatory and autoimmune diseases. The company’s product candidates include Ovasave, a T cell immunotherapy product, which is in Phase IIb placebo controlled study for refractory Crohn's disease; and Col-Treg for the treatment of rare disease Autoimmune Uveitis. Its products in preclinical development stage comprise Myelin-Treg for central nervous system inflammatory diseases; and HSP60-Treg for autoimmune and inflammatory diseases. The company has a strategic partnership with Trizell Holding SA for the development of Ovasave. TxCell S.A. is headquartered in Valbonne, France.

42 Employees
Last Reported Date: 04/10/15

txcell (TXCL) Top Compensated Officers

Executive Chairman
Total Annual Compensation: €60.0K
Vice President of Supply Chain
Total Annual Compensation: €104.0K
Compensation as of Fiscal Year 2014.

txcell (TXCL) Key Developments

TxCell Receives Fast Track Designation from FDA for Ovasave®

TxCell SA announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to TxCell’s lead product Ovasave® for the treatment of moderate to severe Crohn’s disease. Ovasave already has an active IND (Investigational New Drug) with the FDA. The FDA Fast Track program aims to facilitate the development and review of new drugs intended to treat serious or life-threatening conditions that have already demonstrated the potential to address unmet medical needs. The granting of Fast Track Designation will enable TxCell to work more closely with the FDA with the intent to accelerate the drug development program through to approval in order to make relevant medications available to patients sooner. Ovasave is an antigen specific autologous T regulatory somatic cell therapy in development for the treatment of Inflammatory Bowel Disease. Ovasave is currently in a randomised controlled phase IIb study entitled CATS29. The study aims to confirm the benefit of Ovasave for the treatment of patients with refractory Crohn’s disease. The CATS29 study follows an initial phase IIa study entitled CATS1.

TxCell SA Announces FDA Acceptance of IND for Ovasave

TxCell SA announced that the United States Food and Drug Administration (FDA) has accepted TxCell's Investigational New Drug (IND) application for the company's product, Ovasave(R), currently in a phase 2b clinical trial for the treatment of patients with refractory Crohn's disease. The activation of the IND authorizes TxCell to extend the CATS29 study to the United States. The CATS29 study is currently on-going in Europe following its start in December 2014. There are currently 30 study sites operating the study in 6 countries in the EU. It has been designed to include 160 severe refractory Crohn's disease patients. The extension of this study to U.S. sites could be initiated in the first part of 2016. Ovasave materials manufactured in a US or EU GMP facility will be required to start enrolment in a clinical trial under the IND.

TxCell SA Reports Temporary Partial Hold of Activities at Pilot Manufacturing Unit

TxCell SA announced that it has temporarily put its pilot manufacturing facility activities at Besançon, France on partial hold. The decision was made in agreement with the French regulator, Agence Nationale de Sécurité du Médicament or ANSM. The company expects only potential limited impact on clinical product timeline.


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