Edition:
United States

Tigenix NV (G9U.BR)

G9U.BR on Brussels Stock Exchange

0.71EUR
24 Mar 2017
Change (% chg)

€-0.00 (-0.28%)
Prev Close
€0.71
Open
€0.71
Day's High
€0.72
Day's Low
€0.71
Volume
200,447
Avg. Vol
558,192
52-wk High
€1.20
52-wk Low
€0.64

Latest Key Developments (Source: Significant Developments)

Tigenix announces Phase I/II results of AlloCSC-01 in Acute Myocardial Infarction
Monday, 13 Mar 2017 02:00am EDT 

Tigenix NV : Announces Phase I/II results of AlloCSC-01 in Acute Myocardial Infarction . All safety objectives of study have been met . No mortality or major cardiac adverse events (MACE) have been found at 30 days meeting primary end-point of study .No mortality or major cardiac adverse events have been found at 6 months or 12 months follow-up.  Full Article

Tigenix receives positive feedback from FDA on Cx601 global phase III trial protocol
Tuesday, 7 Mar 2017 01:02am EST 

Tigenix Nv : Tigenix receives positive feedback from the FDA on Cx601 global phase III trial protocol . Tigenix NV - received positive feedback from U.S. FDA on an improved protocol for its global phase III trial for treatment of complex perianal fistulas . Tigenix NV - FDA has agreed that BLA could be filed based on efficacy and safety follow-up of patients assessed at week 24, instead of week 52 . Tigenix NV - FDA has agreed to accept fewer patients than originally planned in study . Tigenix NV - global pivotal phase iii trial for U.S. Registration of Cx601 is expected to begin in first half of 2017 .Tigenix NV - is exploring further expedited pathways to accelerate submission and review process for its future BLA.  Full Article

Tigenix receives positive feedback from the FDA on Cx601 global phase III trial protocol
Tuesday, 7 Mar 2017 01:00am EST 

Tigenix NV : Tigenix receives positive feedback from the FDA on cx601 global phase III trial protocol . Agency has agreed to an improved protocol for global phase III trial of Cx601 . FDA has agreed that BLA could be filed based on efficacy and safety follow-up of patients assessed at week 24, instead of week 52 . FDA has agreed to accept fewer patients than originally planned in study, and has endorsed a broader target population that will ultimately facilitate recruitment process . The global pivotal phase III trial for US registration of Cx601 is expected to begin in H1 of 2017. .TiGenix is exploring further expedited pathways to accelerate submission and review process for its future BLA.  Full Article

TiGenix and Takeda report new data on Cx601
Friday, 17 Feb 2017 03:01am EST 

TiGenix NV :TiGenix and Takeda <4502.T> report on Friday morning new data highlighting maintenance of long-term remission of complex perianal fistulas in Crohn's disease patients with Cx601.  Full Article

Tigenix announces positive results of ADMIRE-CD pivotal phase III trial of Cx601
Monday, 6 Feb 2017 01:30am EST 

Tigenix NV : Announces acceptance of Cx601 abstract for oral presentation at 12th Congress of ECCO . Positive results of ADMIRE-CD pivotal phase III trial of Cx601 for complex perianal fistulas in Crohn's disease patients . Data demonstrated that remission produced in these hard-to-treat fistulas by Cx601, a suspension of allogeneic adipose-derived stem cells (eASC), was maintained long-term . Results also support favorable tolerability of Cx601 over long-term - Dr. Marie Paule Richard, Chief Medical Officer at Tigenix .Has an exclusive licensing and commercialization agreement for Cx601, ex-US, with Takeda <4502.T> and expects a decision from the EMA regarding its marketing authorization by year-end 2017.  Full Article

Tigenix submits responses to EMA day 120 list of questions for CX601
Friday, 23 Dec 2016 06:19am EST 

Tigenix NV : Announced on Thursday that it submitted its responses to EMA day 120 list of questions for CX601, product candidate being developed for treatment of complex perianal fistulas in patients with Crohn's disease . Expects to receive EMA day 180 list of outstanding issues in February 2017 .Anticipates a decision from ema on CX601 marketing approval during 2017 which, if approved, would trigger payment by Takeda to Tigenix of 15 million euros ($15.66 million).  Full Article

Tigenix submits day 120 responses to EMA for CX601 marketing authorization
Thursday, 22 Dec 2016 04:03pm EST 

Tigenix NV : Tigenix NV - Tigenix submits day 120 responses to European Medicines Agency for CX601 marketing authorization . Tigenix- expects to receive EMA day 180 list of outstanding issues in Feb 2017, anticipates decision from EMA on CX601 marketing approval during 2017 .Tigenix- if approved, would trigger the payment by Takeda to Tigenix of euro 15 million.  Full Article

Deutsche Bank appointed as depositary bank for sponsored Level III American Depositary Receipt Program of TiGenix NV
Wednesday, 21 Dec 2016 01:47am EST 

Tigenix NV :Announced on Tuesday that Deutsche Bank appointed as sponsored depositary bank for the Level III NASDAQ-listed American Depositary Receipt program of TiGenix NV.  Full Article

Tigenix closes NASDAQ IPO
Tuesday, 20 Dec 2016 10:00am EST 

Tigenix NV : Announces closing of NASDAQ IPO . Closed its initial public offering in USA totaling 35.65 million dollars proceeds from sale of 2,300,000 shares, at a price of $15.50 per American Depository Shares (ADS) . IPO represents 46,000,000 ordinary shares, at a price to public of $15.50 per ADS . Underwriters have now a 30-day option to purchase up to an additional 345,000 ADS's, representing 6,900,000 ordinary shares, to cover over-allotments, if any .Each of ADS's offered represents right to receive twenty (20) ordinary shares.  Full Article

Tigenix announces launch of proposed IPO in U.S.
Monday, 5 Dec 2016 04:05pm EST 

Tigenix Nv : Tigenix announces launch of proposed initial public offering in the United States . Says intends to offer , 2.75 million ads representing 55 million ordinary shares in an initial public offering in united states . Tigenix NV - intends to offer and sell, subject to market and other conditions, 2.75 million american depositary shares .Says each of ADSS offered represents right to receive twenty ordinary shares.  Full Article

More From Around the Web

Belgium's Tigenix says heart attack stem cell trial successful

BRUSSELS Belgian biotech group Tigenix said on Monday its medical trial with a novel treatment for patients at risk of heart failure after a coronary attack was successful.