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): October 25, 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:





    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 October 25, 2007, Genta Incorporated, (the Company), announced that it has completed the filing of the Company’s formal appeal to Dr. Janet Woodcock, Acting Director of the Center for Drug Evaluation Research (CDER), at the U.S. Food and Drug Administration (FDA). The appeal asks that CDER approve the use of Genasense® (oblimersen sodium) Injection plus chemotherapy for patients with relapsed/refractory chronic lymphocytic leukemia (CLL). In December 2006, FDA issued a non-approvable letter for the Company’s New Drug Application (NDA) for Genasense in CLL. This appeal has been submitted in accordance with the Formal Dispute Resolution process that exists within CDER. Responses to CDER appeals are typically made within 30 to 60 days.
Item 9.01 Financial Statements and Exhibits.


 
        
                        
(d) Exhibits.
  

 


 
        
                        
Exhibit 
 Number
 
        
                        
 
 
        
                        
Description
  
 
        
                        
99.1
 
        
                        
 
 
        
                        
Press Release of the Company dated October 25, 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: October 25, 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 October 25, 2007