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): December 11, 2008
GENTA INCORPORATED
(Exact Name of Registrant
as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
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| 0-19635
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33-0326866 |
| (Commission File Number)
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(IRS Employer Identification No.) |
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200 Connell Drive
Berkeley Heights, NJ
(Address of Principal Executive Offices)
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07922
(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a -12) |
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Pre -commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240.14d -2(b)) |
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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 11, 2008, Genta Incorporated, (the Company), announced that the Company has filed an
appeal of the recent negative decision by the Food and Drug Administration’s (FDA) Office of
Oncology Drug Products (OODP) regarding the Company’s New Drug Application (NDA) for Genta’s lead
oncology product, Genasense® (oblimersen sodium) Injection. The NDA proposed the use of Genasense
in combination with chemotherapy as treatment for patients with relapsed or refractory chronic
lymphocytic leukemia (CLL).
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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| Exhibit |
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Description |
99.1
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Press Release of the Company dated December 11, 2008 |