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):  February 6, 2007

 

GENTA INCORPORATED

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware
(State or Other Jurisdiction of Incorporation)

 

0-19635
(Commission File Number)

 

33-0326866
(IRS Employer Identification No.)

 

200 Connell Drive
Berkeley Heights, NJ
(Address of Principal Executive Offices)

 

07922
(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:

 

   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 February 6, 2007, Genta Incorporated, (the Company), issued a press release announcing the Company will appeal the non-approvable notice from the Food and Drug Administration’s (FDA) Office of Oncology Drug Products of its New Drug Application (NDA) for the use of Genasense® (oblimersen sodium) Injection plus chemotherapy in patients with chronic lymphocytic leukemia (CLL).  The appeal will be filed pursuant to the Formal Dispute Resolution process that exists within FDA’s Center for Drug Evaluation and Research (CDER).  The Company filed notice reserving its rights to appeal in December 2006 and expects to complete the filing of this appeal during the current calendar quarter.


Item 9.01 Financial Statements and Exhibits.


(d) Exhibits.


   
 

Exhibit
Number

 

                                      Description

 

99.1

 

Press Release of the Company dated February 6, 2007










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:

February 6, 2007

 

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 of the Company dated February 6, 2007