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): June 30, 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 June 30,
2005 Genta Incorporated (“Genta”) issued a press release announcing that the
Company has filed a formal Letter of Intent with the European Medicines Agency (EMEA)
as the initial step for submission of a Marketing Authorization Application (MAA) for
Genasense® (oblimersen sodium) Injection, the company’s lead anticancer
product, for patients with Advanced Melanoma.
On June 30,
2005 Genta issued a press release announcing that the Company has initiated submission
of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA)
seeking marketing approval of Genasense® (oblimersen sodium) Injection, its lead
anticancer compound, for patients with Relapsed or Refractory Chronic Lymphocytic
Leukemia.
The press
releases are attached hereto as Exhibit 99.1 and 99.2 and incorporated herein by
reference.
| Exhibit Number |
Description | |
| |
|
|
| 99.1 | Press Release dated June 30, 2005 | |
| 99.2 | Press Release dated June 30, 2005 |
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 30, 2005 | By: | /s/ William P. Keane | |
| |
|
|||
| Name: |
William P. Keane | |||
| Title: | Senior Vice President, Chief Financial
Officer and Corporate Secretary
|
|||
EXHIBIT INDEX
| Exhibit Number |
Description |
Sequentially Numbered Page |
|
| 99.1 | Press Release dated June 30, 2005 | ||
| 99.2 | Press Release dated June 30, 2005 |