UNITED STATES
SECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934Date 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
(Registrants 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 Gentas 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 FDAs 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 Gentas 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 Page99.1
Press Release of the Company dated December 21, 2007