Intercept Company Statement on Analyst Note
The FDA provides quarterly information on newly identified safety signals. The Company does not believe that the absence of a listed medicine that was in one quarterly update in a subsequent quarter necessarily indicates that the FDA has completed its evaluation of the NISS.
As Intercept has previously communicated, the Company has submitted a comprehensive safety assessment to the FDA and the dialogue with the FDA regarding the Agency’s evaluation of the NISS for Ocaliva remains ongoing.
As the Company has also previously stated, the FDA notified Intercept in
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Founded in 2002 in
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements regarding the progress, timing and results of our clinical trials, including the timeline or outcome of the
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Source: Intercept Pharmaceuticals, Inc.