Market Overview

GTx Announces FDA Fast Track Designation for Enobosarm

GTx (NASDAQ: GTXI) today announced that the U.S. Food and Drug
Administration (FDA) has designated enobosarm (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 (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.

See full press release

Posted-In: Earnings News Guidance Management

 

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