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EX-99.1 - PRESS RELEASE - GTX INC /DE/d329173dex991.htm

 

 

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) April 4, 2012

 

 

GTx, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-50549   62-1715807

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

175 Toyota Plaza 7th Floor

Memphis, Tennessee

  38103
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (901) 523-9700

(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):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ 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 April 4, 2012, GTx, Inc. issued a press release announcing that the Company has submitted to the U.S. Food and Drug Administration (FDA) a complete response to the FDA’s letter regarding the previously announced Full Clinical Hold of the Company’s clinical trials evaluating Capesaris® (GTx-758) for primary (first line hormonal) androgen deprivation therapy for advanced prostate cancer and secondary (second line) hormonal therapy. A copy of the press release is furnished as Exhibit 99.1 to this Current Report.

 

ITEM 9.01 Financial Statements and Exhibits.

 

  (d) Exhibits

 

Exhibit

Number

  

Description

99.1    Press Release issued by GTx, Inc. dated April 4, 2012


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: April 4, 2012     By:  

/s/ Henry P. Doggrell

      Name: Henry P. Doggrell
      Title:   Vice President, General Counsel and Secretary