Intercept intends to file for accelerated approval in PBC Intercept said in conference presentation slides that it intends to file for accelerated approval for OCA in primary biliary cirrhosis, or PBC, conditional on conducting an additional Phase 3 confirmatory clinical outcomes trial for full approval.
News For ICPT From The Last 14 Days
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Intercept feedback positive, says BofA/Merrill BofA/Merrill's recent discussions with NASH liver expert believes Intercept's OCA path to market may be straight forward and not require CV outcomes data prior to approval and that FLINT study will have a positive impact on the NASH resolution. The firm reiterates its Buy rating and $872 price target.