8-K
 
 
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):   January 5, 2009
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 January 5, 2009, Genta Incorporated, (the Company), announced that that the Company has received notice from the U.S Food and Drug Administration (FDA) that tesetaxel, the latest addition to Genta’s oncology product portfolio, has been granted designation as an “Orphan Drug” for treatment of patients with advanced gastric cancer. Orphan drug status provides for a period of marketing exclusivity, certain tax benefits, and an exemption from certain fees upon submission of a New Drug Application. As a late Phase 2 agent, the Company believes tesetaxel is the leading oral taxane currently in clinical development.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
       
Exhibit
Number		   Description
99.1
  Press Release of the Company dated January 5, 2009

 

 

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 5, 2009      By:   /s/ GARY SIEGEL    
    Name:   Gary Siegel   
    Title:   Vice President, Finance   

 

 

         
EXHIBIT INDEX
         
Exhibit       Sequentially
Number   Description   Numbered Page
99.1
  Press Release of the Company dated January 5, 2009