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 7, 2006 (September 5, 2006)
GTx, Inc.
(Exact name of Registrant as specified in its charter)
|
|
|
|
|
Delaware
|
|
005-79588
|
|
62-1715807 |
(State or other jurisdiction of
|
|
(Commission
|
|
(I.R.S. Employer |
incorporation or organization)
|
|
File Number)
|
|
Identification No.) |
3 N. Dunlap Street
Van Vleet Building
Memphis, Tennessee 38163
(901) 523-9700
(Address, including zip code, of Registrants principal executive offices
Registrants telephone number, including area code,)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
TABLE OF CONTENTS
ITEM 8.01 Other Events.
On September 5, 2006, GTx, Inc. issued a press release announcing that a per
protocol interim safety review by an independent Drug Safety Monitoring Board (DSMB)
recommended that GTx continue clinical development as planned with its two pivotal
Phase III trials of ACAPODENE® (toremifene citrate), a copy of which is furnished
as Exhibit 99.1 to this Current Report.
This release is furnished by GTx pursuant to Item 2.02 of Form 8-K and is not to be
considered filed under the Exchange Act, and shall not be incorporated by
reference into any previous or future filing by the Registrant under the Securities
Act or the Exchange Act.
ITEM 9.01 Financial Statements and Exhibits.
(c) Exhibits
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
99.1 |
|
|
Press Release issued by GTx, Inc. dated September 5, 2006 |
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.
|
|
|
|
|
|
GTx, Inc.
|
|
Date: September 7, 2006 |
By: |
/s/ Henry P. Doggrell
|
|
|
|
Name: |
Henry P. Doggrell |
|
|
|
Title: |
Vice President, General Counsel
and Secretary |
|