GTx Drug Receives Fast-Track Status From FDA

Tuesday, January 8, 2013, Vol. 128, No. 5

MEMPHIS (AP) – An experimental GTx Inc. treatment for muscle wasting in patients with a form of lung cancer will be reviewed under the Food and Drug Administration's fast-track program. Its shares climbed more than 12 percent in premarket trading.

The Memphis, Tenn., company said Tuesday that the drug, enobosarm, is being studied in a couple of late-stage trials involving patients with advanced forms of non-small cell lung cancer.

The FDA's fast-track program is designed to speed up the approval of drugs that treat serious or life-threatening diseases for which there are few other therapies. Those that receive fast-track status receive extra meetings and correspondence with regulators throughout the review process.

The status also raises the possibility of a faster, priority review from the FDA once the drug developer seeks approval.

GTx focuses on developing treatments for cancer and other serious medical conditions. Enobosarm is the most advanced product in the company's drug development pipeline.

GTx shares rose 60 cents, or 12.6 percent, to $5.35 in premarket trading. Its shares have traded in a 52-week range of $2.62 to $6.55 per share.

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