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News Breaks
January 8, 2013
06:32 EDTGTXIFDA designates GTx's enobosarm as Fast Track development program
GTx announced that the FDA has designated enobosarm, or GTx-024, for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer as a Fast Track development program. Fast Track status is a process designed by FDA to facilitate the development and expedite the review of new drug candidates that are intended to treat serious diseases and have the potential to fill an unmet medical need. With a Fast Track designation, there is an increased possibility for a priority review of a new drug application, or, NDA, filed for the drug candidate and more opportunity for more frequent interactions with the FDA both prior to and following the filing of a NDA.
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April 15, 2014
08:56 EDTGTXIGTx Chief Scientific Officer James Dalton resigns
GTx disclosed in a regulatory filing that James Dalton, Vice President, Chief Scientific Officer, notified the company of his decision to resign from his employment with GTx. Dalton is leaving GTx to become Dean of the University of Michigan College of Pharmacy. GTx currently expects to engage Dalton as a consultant to the company following his employment termination.

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