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): December 21, 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 December 21, 2007, Genta Incorporated, (the Company), announced that the Company has received notice from the Food and Drug Administration (FDA) that FDA has extended its review period of Genta’s request for correction of certain information that was filed pursuant to the Information Quality Act for an additional 60 days. The requested correction relates to FDA’s assessment of progression-free survival (PFS) in the Phase 3 trial of Genasense® (oblimersen sodium injection) that was presented to the Oncology Drug Advisory Committee (ODAC) that considered Genta’s New Drug Application for Genasense in patients with advanced melanoma.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit
Number

 

Description

99.1

 

Press Release of the Company dated December 21, 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: December 21, 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 December 21, 2007