Targanta Therapeutics Corp (MM) (NASDAQ:TARG)
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Targanta Therapeutics Corporation (Nasdaq: TARG) announced today that
the U.S. Food and Drug Administration (FDA) has posted on its website
briefing documents for the November 19, 2008 Anti-Infective Drugs
Advisory Committee (AIDAC) meeting. AIDAC will review Targanta’s New
Drug Application (NDA) for oritavancin for the treatment of complicated
skin and skin structure infection (cSSSI) caused by gram-positive
organisms, including methicillin-resistant Staphylococcus aureus,
or MRSA.
Briefing documents from FDA and Targanta can be found on FDA’s website
at http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4394b2-00-Index-FDA.htm.
About Oritavancin
Oritavancin is a novel semi-synthetic lipoglycopeptide antibiotic
candidate with potent bactericidal (killing) activity against a broad
spectrum of gram-positive bacteria, including methicillin-resistant Staphylococcus
aureus, or MRSA. These types of resistant infections have created a
market that IMS Health estimated to be over one billion dollars in the
U.S. in 2007 and growing rapidly. In its intravenous (IV) formulation,
the product candidate has been tested in over 1,900 individuals and has
completed two Phase 3 studies for the treatment of complicated skin and
skin structure infections (cSSSI) in which the primary endpoints were
met. The NDA dossier includes data from more than 2,100 individuals and in
vitro activity data on oritavancin against more than 9,000 clinical
bacterial isolates, including a broad range of gram-positive strains
resistant to commonly used antibiotics such as oxacillin, methicillin,
vancomycin, daptomycin, and linezolid. FDA’s action date for the
oritavancin NDA is December 8, 2008.
About Targanta Therapeutics
Targanta Therapeutics Corporation (Nasdaq: TARG) is a biopharmaceutical
company focused on developing and commercializing innovative antibiotics
to treat serious infections in the hospital and other institutional
settings. The Company’s pipeline includes an intravenous version of
oritavancin, a semi-synthetic lipoglycopeptide antibiotic currently
awaiting U.S. and EU regulatory approval and a program to develop an
oral version of oritavancin for the possible treatment of Clostridium
difficile infection. The Company has operations in Cambridge, MA,
Indianapolis, IN, and Montreal, Québec, Canada. For more information on
Targanta, visit www.targanta.com.
Safe Harbor Statement
This press release contains “forward-looking statements” that are made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These are statements that are predictive
in nature, that depend upon or refer to future events or conditions or
that include words such as “potential,” “may,” "will," "expects,"
"projects," "anticipates," "estimates," "believes," "intends," "plans,"
"should," "seeks," “hope” and similar expressions. Forward-looking
statements involve known and unknown risks and uncertainties that may
cause actual future results to differ materially from those projected or
contemplated in the forward-looking statements. Forward-looking
statements may be significantly impacted by certain risks and
uncertainties described in Targanta’s filings with the Securities and
Exchange Commission. The risks and uncertainties referred to above
include, but are not limited to, delays in obtaining or a failure to
obtain regulatory approval for Targanta’s product candidates;
unfavorable clinical trial results; Targanta’s potential inability to
initiate and complete pre-clinical studies and clinical trials for its
product candidates; the possibility that results of pre-clinical studies
are not necessarily predictive of clinical trial results; and those
other risk factors that are described more fully in the Company’s
filings with the Securities and Exchange Commission. Targanta does not
undertake any obligation to update any of these forward-looking
statements to reflect a change in its views or events or circumstances
that occur after the date of this release.