Kiadis Pharma N.V.
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Publicatie datum
02 jun 2016 - 07:00
Statutaire naam
Kiadis Pharma N.V.
Titel
Kiadis Pharma announces its decision to file for marketing authorization with the European Medicines Agency (EMA) for ATIR101™ in blood cancers
Bericht
Amsterdam, The Netherlands, June 2, 2016, – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces a regulatory strategy update that, based on positive Phase II data, it has taken the decision to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead product ATIR101™ for use in blood cancers to reduce relapse rates, Transplant Related Mortality (TRM) and Graft-versus-Host-Disease (GVHD) in the context of a hematopoietic stem cell transplantation using a haploidentical donor. The Company will now start compiling an MAA document and anticipates submitting the application to EMA in Q1, 2017.
Datum laatste update: 07 februari 2025