Market Overview

Intercept Pharma Investors Cheering FDA Briefing Doc Release


Shares of Intercept Pharmaceuticals Inc (NASDAQ: ICPT) were trading higher by more than 6 percent ahead of Tuesday's market open as investors found the U.S. Food and Drug Administration's latest briefing documents to be encouraging.

The FDA has a scheduled advisory committee meeting on Thursday and will discuss the new drug application 20799, obeticholic acid oral tablets, submitted by Intercept Pharmaceuticals for the treatment of primary biliary cirrhosis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

Related Link: Ironwood Pharmaceuticals Falls 6% Following Disappointing Phase 2a Study

The Street's biotech columnist Adam Feuerstein tweeted that he doesn't "see any nasty surprises in the FDA's summary of the OCA data." He added in a follow-up tweet that the stock's "current valuation already exceeds potential sales of OCA in PBC, so label restriction to mild patients doesn't really matter."

Posted-In: Adam FeuersteinBiotech News Health Care FDA Movers Trading Ideas General


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