Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announced that it notified the European Medicines Agency (EMA) of its intent to submit a MAA for C-Cure® in November 2016.
The MAA filing will trigger the appointment of Rapporteurs and Co-Rapporteurs who will review Celyad’s submission and therefore allows the Company to prepare the pre-submission meetings. Appointment of the (co-)Rapporteurs is expected by the end of April 2016.
Dr. Christian Homsy, CEO: “This notification to the EMA represents another step on the path to the commercialization of C-Cure®. We are optimistically awaiting the CHART-1 Phase III results which are expected end of June 2016. These data will trigger the actual marketing authorization application”.
Dr. Jean-Pierre Latere, Head of the Cardiovascular Franchise: “Celyad continues on its journey to bring innovative best-in-class treatments to patients. Engaging with the EMA represents an important milestone and we are committed to work diligently to execute on our clinical development plan and to make C-Cure® available.”
