Cx601 regulatory update

FDA agreed to a shortened Phase III trial design for Cx601 to treat perianal fistulas in patients with Crohn's disease (CD) that would allow the company to submit a BLA for the product a year earlier than originally planned. The amended protocol will evaluate safety and efficacy data at week 24, rather than week 52 as stipulated in the original 2015 SPA. TiGenix said the updated design reduces patient enrollment to 320 from 360 and broadens eligibility requirements around prior patient therapies to speed enrollment. The company expects to begin the Phase III trial this half and submit a BLA by 1H20...