EpiCept Files for European Marketing Approval
EpiCept Corporation (EPCT) announced late on Monday it had sent a Market Authorization Application (MAA) with the European Medicines Agency for the approval of Ceplene.
Ceplene is EpiCept's lead oncology product that is administered with Interleukin-2 for first remission in Acute Myeloid Leukemia patients.
The odds look good for approval as the European Agency had already designated Ceplene Orphan Drug Status, and phase 3 results had met critical endpoints.
CEO Talley believes the market potential for Ceplene in the European Union alone can exceed $300 million.
Shares of EpiCept were already up 18% in pre-market trading.
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EpiCept Corporation (EPCT) announced late on Monday it had sent a Market Authorization Application (MAA) with the European Medicines Agency for the approval of Ceplene.
Ceplene is EpiCept's lead oncology product that is administered with Interleukin-2 for first remission in Acute Myeloid Leukemia patients.
The odds look good for approval as the European Agency had already designated Ceplene Orphan Drug Status, and phase 3 results had met critical endpoints.
CEO Talley believes the market potential for Ceplene in the European Union alone can exceed $300 million.
Shares of EpiCept were already up 18% in pre-market trading.
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posted by Nico at
7:31 AM
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