TiGenix says it's on track for 2017 EMA decision on Cx601

TiGenix (Euronext: TIG) says it has received a Day 180 List of Outstanding Issues (LoOI) notice from the European Medicine Agency for its experimental gastro-intestinal candidate Cx601.

The drug is being developed for the treatment of perianal fistulas in patients with Crohn’s disease. The Leuven, Belgium-based specialty biopharmaceutical company did not say what was on the letter, but stated: “After reviewing the LoOI, we are confident in our ability to provide detailed and clarifying responses to the EMA and remain on track to receive a Marketing Authorization decision for Cx601 in 2017.”

The company’s application has been paused - known as a "clock stop" period - while the company prepares its response. The Day 180 LoOI letter is a standard part of the EMA’s regulatory approval process.