Kiadis Pharma on track with European reg­u­la­to­ry review for ATIR101

Responses sub­mit­ted to EMA Day 120 list of ques­tions

Amsterdam, The Netherlands, March 28, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing a T-cell immunother­a­py prod­uct can­di­date designed to reduce Graft ver­sus Host Disease (GVHD) in hematopoi­et­ic stem cell trans­plan­ta­tions (HSCT), today con­firms it has sub­mit­ted its respons­es to the European Medicines Agency’s (EMA) Day 120 List of Questions for its lead prod­uct can­di­date ATIR101 with­in the time­line that had been agreed with EMA and announced in September 2017.

Arthur Lahr, CEO of Kiadis Pharma, com­ment­ed: “We are pleased to have sub­mit­ted our respons­es to EMA’s Day 120 List of Questions in a time­ly man­ner. We believe we have ade­quate­ly addressed the ques­tions and remain on track to poten­tial­ly obtain a pos­i­tive CHMP opin­ion for ATIR101 in Q4 2018 and (con­di­tion­al) approval from the European Commission in Q1 2019, which would allow for a European launch in H2 2019.

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