|
|
|
|
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 18, 2007 |
||
|
|
||
|
GENTA INCORPORATED |
||
|
(Exact Name of Registrant |
||
|
|
||
|
|
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:
Written communications pursuant to
Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule
14a-12 under the Exchange Act (17 CFR 240.14a -12)
Pre -commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d -2(b))
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 18, 2007, Genta Incorporated, (the Company), issued a press release announcing that the Company intends to request review of a decision by officials from the Food and Drug Administration (FDA) not to overturn FDA’s non-approvable decision for the New Drug Application (NDA) for Genasense® (oblimersen sodium) Injection in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Following FDA’s established Dispute Resolution Process, Genta expects to formally submit its request to Dr. Steven Galson, CDER Director, within the next four weeks and the Company anticipates a decision from CDER in the third quarter of 2007.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
|
Exhibit Number |
Description |
||
|
99.1 |
Press Release of the Company dated June 18, 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: |
June 19, 2007 |
|
By: |
/s/ RICHARD J. MORAN |
|
|
|
|
|
|
Name: |
Richard J. Moran |
|
|
|
|
|
Title: |
Senior Vice President, Chief Financial Officer and Corporate Secretary |
EXHIBIT INDEX
|
Exhibit |
Description |
Sequentially |
|
99.1 |
Press Release of the Company dated June 18, 2007
|
|