GTx Receives Complete Response Letter from FDA for Toremifene 80 mg New Drug Application

MEMPHIS, Tenn.--(Business Wire)--
GTx, Inc. (NASDAQ: GTXI) today announced that it has received a Complete
Response Letter issued by the United States Food and Drug Administration (FDA)
regarding its New Drug Application (NDA) for toremifene 80 mg to reduce
fractures in men with prostate cancer receiving androgen deprivation therapy
(ADT).

The FDA identified two deficiencies in the Complete Response Letter and
recommended that the following information be provided to the FDA to address
these clinical deficiencies: (i) results of a second adequate and well
controlled Phase III trial demonstrating the safety and efficacy of toremifene
citrate 80mg to reduce fractures in men with prostate cancer on ADT and (ii)
results from an adequate and well-controlled clinical trial demonstrating that
toremifene treatment to reduce fractures in men with prostate cancer on ADT does
not have a detrimental effect on either time-to-disease progression or overall
survival. GTx is requesting a meeting with the FDA to determine the appropriate
next steps regarding the NDA.

Conference Call and Webcast

GTx will hold a conference call and webcast today at 9:00 a.m. Eastern Time to
discuss the Complete Response Letter. To listen to the conference call, please
dial:

* 888-396-2369 from the United States and Canada or
* 617-847-8710 (International)
The access code for the call is 59484869.

A playback of the call will be available beginning today at 12:00 p.m. Eastern
Time through November 16, 2009, and may be accessed by dialing:

* 888-286-8010 from the United States and Canada or
* 617-801-6888 (International)
The reservation number for the replay is 47774982.

Additionally, you may access the live and subsequently archived webcast of the
conference call from the Investor Relations section of the Company`s website at
http://www.gtxinc.com.

About GTx

GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company
dedicated to the discovery, development, and commercialization of small
molecules that selectively target hormone pathways to prevent and treat cancer,
fractures and bone loss, muscle loss and other serious medical conditions. GTx
is pursuing marketing approval in the United States for toremifene 80 mg to
reduce fractures in men with prostate cancer on ADT. GTx is also developing
toremifene 20 mg in an ongoing pivotal Phase III clinical trial for the
prevention of prostate cancer in high risk men with high grade prostatic
intraepithelial neoplasia. GTx has licensed to Ipsen Developments Limited
exclusive rights in the European Union, Switzerland, Norway, Iceland,
Lichtenstein, and the Commonwealth of Independent States to develop and
commercialize toremifene for all indications which GTx has licensed from Orion
Corporation. In December 2007, GTx and Merck & Co., Inc. entered into a
collaboration to discover and develop selective androgen receptor modulators, or
SARMs, a new class of drugs with the potential to treat chronic sarcopenia,
which is the loss of skeletal muscle mass resulting in reduced physical strength
and ability to perform activities of daily living and other musculoskeletal
wasting or muscle loss conditions, including muscle loss in patients with
chronic obstructive pulmonary disease. GTx and Merck are evaluating multiple
SARM product candidates, including Ostarine (designated by Merck as MK-2866) and
MK-0773, for a variety of musculoskeletal wasting indications. GTx is also
developing GTx-758, an oral luteinizing hormone inhibitor for the treatment of
advanced prostate cancer.

Forward-Looking Information is Subject to Risk and Uncertainty

This press release contains forward-looking statements based upon GTx`s current
expectation, including but not limited to statements relating to GTx`s plans to
continue to pursue marketing approval for toremifene 80 mg and the continued
development of GTx`s other product candidates. Forward-looking statements
involve risks and uncertainties. GTx`s actual results and the timing of events
could differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which include, without
limitation, the risks that (i) GTx and its collaboration partners will not be
able to commercialize their product candidates if clinical trials do not
demonstrate safety and efficacy in humans, including in any additional clinical
trials required by the FDA in connection with the NDA for toremifene 80 mg to
reduce fractures in men with prostate cancer on ADT; (ii) GTx may not be able to
obtain required regulatory approvals to commercialize its product candidates,
including toremifene 80 mg to reduce fractures in men with prostate cancer on
ADT, in a timely manner or at all; (iii) clinical trials being conducted by GTx
and its collaboration partners may not be completed on schedule, or at all, or
may otherwise be suspended or terminated; and (iv) GTx could utilize its
available cash resources sooner than it currently expects and may be unable to
raise capital when needed, which would force GTx to delay, reduce or eliminate
its product development programs or commercialization efforts. You should not
place undue reliance on these forward-looking statements, which apply only as of
the date of this press release. GTx`s quarterly report on Form 10-Q filed August
10, 2009 contains under the heading, "Risk Factors," a more comprehensive
description of these and other risks to which GTx is subject. GTx expressly
disclaims any obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to reflect any
change in its expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based.

GTx, Inc.
McDavid Stilwell, 901-507-2667
Director, Corporate Communications & Financial Analysis

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