UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): December 29, 2005

GENTA INCORPORATED
(Exact Name of Registrant as Specified in Its Charter)

Delaware
(State or Other Jurisdiction of Incorporation)

0-19635     33-0326866
(Commission File Number)     (IRS Employer Identification No.)
   
Two Connell Drive
Berkeley Heights, NJ
    07922
(Address of Principal Executive Offices)     (Zip Code)


(908) 286-9800
(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:

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 December 29, 2005, Genta Incorporated (NASDAQ: GNTA) issued a press release announcing that the Company has completed the filing of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead anticancer drug, Genasense® (oblimersen sodium) Injection. The application proposes the use of Genasense® plus fludarabine and cyclophosphamide as treatment for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). A copy of the press release is furnished as Exhibit 99.1 to this report and incorporated herein by reference.

On January 3, 2006, Genta Incorporated issued a press release announcing that the Company has completed a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) that seeks approval of Genasense® in combination with chemotherapy for the treatment of patients with advanced malignant melanoma. A copy of the press release is furnished as Exhibit 99.2 to this report and incorporated herein by reference.

The information in this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Exhibit
Number
          Description

 
 99.1   Press Release dated December 29, 2005
     
 99.2   Press Release dated January 3, 2006

 


 

SIGNATURES

      Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

    GENTA INCORPORATED
     

Date:  January 3, 2006 By:    /s/ Richard J. Moran
  
  
        Name:   
Richard J. Moran
      Title:  Senior Vice President, Chief Financial Officer and Corporate Secretary

 


 

EXHIBIT INDEX

Exhibit
Number
  Description Sequentially
Numbered Page
        
99.1   Press Release dated December 29, 2005  
        
99.2   Press Release dated January 3, 2006