8-K 1 file1.htm FORM 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): June 6, 2008

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 June 6, 2008, Genta Incorporated, (the Company), announced that it has submitted an amendment to the Food and Drug Administration (FDA) for its New Drug Application (NDA) for Genasense® (oblimersen sodium) Injection plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The submission is based on new information from the Company’s completed Phase 3 trial that showed, among other findings, a significant increase in overall survival for patients who achieved a complete or partial response when treated with Genasense plus chemotherapy compared with patients treated with chemotherapy alone. The data were presented at an oral session at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago on Monday June 2, 2008.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit
Number

 

Description

99.1

 

Press Release of the Company dated June 6, 2008

 

 



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: June 6, 2008

 

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 June 6, 2008