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."
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in