Endocyte to Submit EU Conditional Marketing Authorization Applications for EC145 and EC20

Endocyte, Inc. ECYT today announced that, per discussions with EU health authorities, the Company will submit EU conditional marketing authorization applications (MAA) for EC145 and EC20 for treatment of patients with folate-receptor positive platinum resistant ovarian cancer. The therapeutic, EC145, and the diagnostic imaging agent, EC20, have also both been granted orphan drug status by the European Commission. "After discussions with EU health authorities about Phase 3 trial plans and updated clinical data, including an updated overall survival analysis, we are pleased to move forward with these applications," said Ron Ellis, Endocyte's president and chief executive officer. "Targeting patients with a high unmet medical need is a prerequisite to pursuing this regulatory path and, by any measure, these patients fit that definition."
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