Intercept +5.6% AH on FDA fast-track designation

The FDA has granted fast-track designation for the use of obethicholic acid (OCA) for treating primary biliary cirrhosis (PBC).

Intercept (ICPT) plans to complete a new drug application for OCA in 1H15. The NDA will include data from Intercept's Phase 3 trial and two randomized Phase 2 trials.

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