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): July 19, 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.) |
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| 200 Connell Drive Berkeley Heights, NJ (Address of Principal Executive Offices) |
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:
| 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 July 19, 2007, Genta Incorporated, (the Company), issued a press release announcing that the Company has received notice from the European Medicines Agency (EMEA) that the requested re-examination by the Committee for Medicinal Products for Human Use (CHMP) has reaffirmed a negative opinion for approval of the Company’s marketing authorization application (MAA) for Genasense® (oblimersen). The MAA proposed the use of Genasense plus dacarbazine for treatment of patients with advanced melanoma.
Item 9.01 Financial Statements and Exhibits.
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(d) Exhibits. |
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Exhibit |
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Description |
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99.1 |
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Press Release of the Company dated July 19, 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.
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GENTA INCORPORATED | ||
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By: |
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Name: |
Richard J. Moran | |
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Title: |
Senior Vice President, Chief Financial Officer and Corporate Secretary | |
EXHIBIT INDEX
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Exhibit |
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Description |
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Sequentially |
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99.1 |
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Press Release of the Company dated July 19, 2007 |
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