TARG Targanta Therapeutics Corp (MM)

 

 

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 8, 2008

 

 

Targanta Therapeutics Corporation

(Exact Name of Registrant as Specified in Its Charter)

 

 

Delaware

(State or Other Jurisdiction

of Incorporation)

 

1-33730		20-3971077
(Commission File Number)		(IRS Employer Identification No.)

 

222 Third Street, Suite 2300 Cambridge, MA		02142-1122
(Address of Principal Executive Offices)		(Zip Code)

(617) 577-9020

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(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))

 

 

 

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INFORMATION TO BE INCLUDED IN THE REPORT

 

Item 8.01.

Other Events.

On December 8, 2008, Targanta Therapeutics Corporation issued a press release announcing that it has received from the U.S. Food and Drug Administration (FDA) a Complete Response Letter stating that the registrant’s New Drug Application (NDA) did not contain sufficient evidence to demonstrate the safety and efficacy of oritavancin for the treatment of complicated skin and skin structure infections (cSSSI). The FDA letter states that before the NDA can be approved, it will be necessary for the registrant to perform an additional well-controlled clinical study to demonstrate the efficacy and safety of oritavancin in patients with cSSSI. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

99.1        Press Release of the registrant dated December 8, 2008.

 

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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.

 

		TARGANTA THERAPEUTICS CORPORATION
		By:		/s/    Daniel S. Char
Date: December 9, 2008				Daniel S. Char
				Vice President, General Counsel and Secretary

 

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EXHIBIT INDEX

 

Exhibit No.		Description of Exhibit
99.1		Press Release of the registrant dated December 8, 2008.

 

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