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):March 6, 2009 (March 5, 2009)
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.) |
175 Toyota Plaza
7th Floor
Memphis, Tennessee 38103
(901) 523-9700
(Address, including zip code, of Registrant’s principal executive offices
Registrant’s 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))
| | | |
| ITEM 8.01 | | Other Events. |
| | | |
| | | On March 5, 2009, GTx, Inc. issued a press release announcing that the United States Food and Drug Administration (FDA) will target a Prescription Drug User Fee Act agency action date of October 30, 2009 for the toremifene 80 mg New Drug Application (NDA), which is within 10 months of the submission of the NDA, a copy of which is furnished as Exhibit 99.1 to this Current Report. |
| | | |
| ITEM 9.01 | | Financial Statements and Exhibits. |
| | | |
| | | (c) Exhibits |
| | | |
| Exhibit | | |
| Number | | Description |
| 99.1 | | Press Release issued by GTx, Inc. dated March 5, 2009 |
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: March 6, 2009 | | By: | | /s/ Mark E. Mosteller |
| | | | | |
| | | | | Name: Mark E. Mosteller |
| | | | | Title: Vice President, Chief Financial Officer
and Treasurer |
