Intercept Pharmaceuticals, Inc.
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Latest From Intercept Pharmaceuticals, Inc.
Still working to refile its NASH fibrosis NDA 22 months after an FDA complete response letter, Intercept gets $405m up front for its ex-US business, including commercial rights to Ocaliva in PBC.
US FDA currently reports about two dozen Accelerated Approval having ‘delays’ in the confirmatory trials. COVID is one factor in some – and the agency also appears to be clearing out some of the others.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
David Loew has assembled a strong business development team which secured seven licensing pacts in 2021 and the Ipsen CEO tells Scrip that this year should see more of the same.