Leerink Partners analyst, Joseph Schwartz noted that Intercept Pharmaceuticals (NASDAQ: ICPT) announced that the FDA has extended the PDUFA date for its priority review application of Obeticholic acid (OCA) in primary biliary cirrhosis/ cholangitis (PBC) by 3 mos. to May 29, 2016. ICPT stated that FDA had requested additional information, to which ICPT has recently submitted additional clinical data analyses.

The FDA has not published official drug development guidance for PBC as there hasn't been a novel therapeutic studied in clinical research for decades now, and AASLD and EASL medical guidelines haven't been updated since 2009.

AdCom panel on Apr 7th is likely to include another heated debate following FDA's stringent review (as has been the case lately w/ rare disease drug reviews), mainly around ICPT's choice of surrogate efficacy endpoint and how that may balance its adverse safety profile causing elevation in pruritus and possibly LDL-C in NASH.

Consensus sales ests. of $38MM for 2016 may need to come down further in light of this event, which had already begun to factor in a slow launch trajectory following mgmt.'s recent cautious stance at Commercial Day

The firm made no change to its Market Perform or price target of $214.

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Shares of Intercept Pharmaceuticals closed at $165.95 yesterday.