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 6, 2010

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.)
 
200 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 April 6, 2010, Genta Incorporated, (the Company), announced that that the U.S. Food and Drug Administration (FDA) has granted the Company’s request for “Fast Track” designation of tesetaxel for treatment of patients with advanced gastric cancer.  Tesetaxel — a late Phase 2 oncology product — is the leading oral taxane currently in clinical development.

Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.  The designation typically enables a Company to submit a New Drug Application (NDA) on a “rolling” basis with ongoing FDA review during the submission process.  NDAs with Fast Track designation are also usually granted priority review by FDA at the time of submission.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit
Number
  
Description
99.1
  
Press Release of the Company dated April 6, 2010

 
 
 
 
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:
April 6, 2010
  
By:
/s/ GARY SIEGEL
       
Name:
Gary Siegel
       
Title:
Vice President, Finance

 
 
 
 
EXHIBIT INDEX
 
Exhibit
Number
  
Description
  
Sequentially
Numbered Page
         
99.1
  
Press Release of the Company dated April 6, 2010