UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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 29, 2005
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.) | ||
| Two
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 December 29, 2005, Genta Incorporated (NASDAQ: GNTA) issued a press release announcing that the Company has completed the filing
of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead anticancer drug, Genasense® (oblimersen
sodium) Injection. The application proposes the use of Genasense® plus fludarabine and cyclophosphamide as treatment for patients
with relapsed or refractory chronic lymphocytic leukemia (CLL). A copy of the press release is furnished as Exhibit 99.1 to this
report and incorporated herein by reference.
On January 3, 2006, Genta Incorporated issued a press release announcing that the Company has completed a Marketing Authorization
Application (MAA) to the European Medicines Agency (EMEA) that seeks approval of Genasense® in combination with chemotherapy for the
treatment of patients with advanced malignant melanoma. A copy of the press release is furnished as Exhibit 99.2 to this report and
incorporated herein by reference.
The information in this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the
“Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any
filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Exhibit Number |
Description | |
|
|
|
|
| 99.1 | Press Release dated December 29, 2005 | |
| 99.2 | Press Release dated January 3, 2006 |
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: | January 3, 2006 | 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 dated December 29, 2005 | ||
| 99.2 | Press Release dated January 3, 2006 |