TiGenix NV (Euronext Brussels and Nasdaq: TIG) is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells.
Two products from the adipose-derived stem cell technology platform are currently in clinical development.
- Cx601 has successfully completed a Phase III for the treatment of complex perianal fistulas in Crohn’s disease patients. On July 4, 2016, we entered into a licensing agreement with Takeda, a large pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to commercialize Cx601 for complex perianal fistulas outside the United States.
- Cx611 has completed a European Phase I safety trial and is currently preparing to initiate a Phase I/II clinical trial in severe sepsis in Europe in the fourth quarter of 2016.
Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product, AlloCSC-01, is currently in a Phase II clinical trial in acute myocardial infarction (AMI).
In addition, the second product candidate from the cardiac stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being developed in a chronic indication.
TiGenix is based in Leuven, Belgium, and has operations in Madrid, Spain.
Licensing Agreement with Takeda for Ex-U.S. rights to Cx601 for the Treatment of Complex Perianal Fistulas in Patients with Crohn’s Disease
Six-month Phase I/II results of AlloCSC-01 in Acute Myocardial Infarction
Announces positive 52-week Phase III results of Cx601 in complex perianal fistulas in Crohn’s disease patients
Submits MAA to EMA for Cx601 for the treatment of complex perianal fistulas in Crohn’s disease patients
Completes enrolment of its AlloCSC-01 Phase I/II study in acute myocardial infarction
AlloCSC-01 Phase I Data Presented at the Congress of the European Society of Cardiology
TiGenix announces Cx601 meets primary endpoint in pivotal Phase III trial
Safety and tolerability of Cx611 confirmed in Phase I sepsis challenge trial
TiGenix NV successfully places EUR 25 million convertible bonds
European Medicines Agency renews Marketing Authorization for ChondroCelect
TiGenix announces development plan for Cx611 in early rheumatoid arthritis and severe sepsis
TiGenix sells manufacturing facility to PharmaCell
TiGenix secures Euro 10 million debt financing through Kreos Capital
TiGenix raises Euro 12 million through private placement with strategic investor, Grifols
TiGenix raises Euro 6.5 million in private placement
TiGenix reports positive Phase IIa trial results for Cx611 in refractory rheumatoid arthritis
Cx601 Phase III in perianal fistulas enrolls first patients
Cx611 Phase IIa in rheumatoid arthritis completes enrollment
Cx621 Phase I successfully concluded
TiGenix obtains EUR 5 million financing facility for phase III fistula program in Crohn's disease
Positive 5 year data on ChondroCelect published in AJSM
TiGenix closes EUR 15.2 million rights offering
Spin-out of drug discovery platform into Arcarios
Commercial launch of ChondroCelect in Europe
ChondroCelect approved by EMA
TiGenix receives positive CHMP opinion for ChondroCelect
Initial Public Offering, raising a total of €46m
Incorporation of TiGenix
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