UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 14, 2005
GTx, Inc.
(Exact name of registrant as specified in its charter)
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| Delaware
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005-79588
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62-1715807 |
| (State or other jurisdiction of
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(Commission
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(I.R.S. Employer |
| incorporation or organization)
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File Number)
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Identification No.) |
3 N. Dunlap Street
3rd Floor, Van Vleet Building
Memphis, Tennessee 38163
(901) 523-9700
(Address, including zip code, and telephone number,
including area code, of registrant’s principal executive offices)
(Former name or former address, if changed since last report)
TABLE OF CONTENTS
ITEM 8.01 Other Events.
On September 14, 2005, GTx, Inc. announced that the Company has received a response letter
from the Division of Oncology Drug Products of the United States Food and Drug Administration
related to GTx’s Special Protocol Assessment (SPA) on the design of its pivotal Phase III clinical
trial of ACAPODENE® for the prevention of prostate cancer in high risk men. The full text of the
press release issued in connection with the announcement is furnished as Exhibit 99.1 to this
Current Report on Form 8-K.
ITEM 9.01 Financial Statements and Exhibits.
(c) Exhibits
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Description |
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99.1 |
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Press Release issued by GTx, Inc. dated September 14, 2005 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the
Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
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GTx, Inc.
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| Date: September 14, 2005 |
By: |
/s/ Henry P. Doggrell
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Name: |
Henry P. Doggrell |
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Title: |
Vice President, General Counsel/Secretary |
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