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VOL. 128 | NO. 5 | Tuesday, January 08, 2013

GTx Drug Receives Fast-Track Status From FDA

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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.

Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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RECORD TOTALS DAY WEEK YEAR
PROPERTY SALES 110 154 13,810
MORTGAGES 135 193 18,019
FORECLOSURE NOTICES 1 29 3,534
BUILDING PERMITS 430 430 32,733
BANKRUPTCIES 52 130 13,133
BUSINESS LICENSES 20 45 4,750
UTILITY CONNECTIONS 83 204 20,104
MARRIAGE LICENSES 0 33 4,230

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