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UNITED STATES |
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SECURITIES AND EXCHANGE COMMISSION |
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WASHINGTON, D.C. 20549 |
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CURRENT REPORT |
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PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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Date of report (Date of earliest event reported): September 6, 2006 |
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GENTA INCORPORATED |
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________________________________________ |
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Delaware |
000-19635 |
33-0326866 |
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(State or Other Jurisdiction |
(Commission File Number) |
(I.R.S. Employer |
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200 Connell Drive, Berkeley Heights, NJ |
07922 |
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(Address of Principal Executive Offices) |
(Zip Code) |
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(908) 286-9800 |
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(Registrant’s telephone number, including area code) |
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(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 (see General Instruction A.2. below):
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 September 6, 2006, Genta Incorporated, a Delaware corporation (the “Company”), issued a press release announcing that a majority of members on the Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted not to recommend approval of Genasense® (oblimersen sodium) Injection for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). While the committee’s recommendation is not binding, the FDA will consider this opinion during completion of its ongoing review of the Genasense New Drug Application (NDA), which is targeted for October 29, 2006.
A copy of the press release is filed as Exhibit 99.1 to this report and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit No. |
Description |
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99.1 |
Press Release of the Company dated September 6, 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 |
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| By: | /s/ Richard J. Moran | |
| Richard J. Moran Senior Vice President, Chief Financial Officer and Corporate Secretary |
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Dated: September 7, 2006