Biotech Values

[DewDiligence]

ICPT -6%/AH on 3-month PDUFA extension in PBC; new PDUFA date is 5/29/16 with an FDA advisory panel on 4/7/16:

http://finance.yahoo.com/news/fda-extends-pdufa-date-obeticholic-220000630.html

In response to an information request from the FDA, additional clinical data analyses have been submitted. To provide time for a full review of the submission, the original PDUFA date of February 29, 2016 has been extended by three months, resulting in a new PDUFA date of May 29, 2016. The FDA has also notified Intercept of a planned advisory committee meeting date of April 7, 2016.

PBC (not NASH) is the lead indication for OCA. Please see #msg-113816778 for info on ICPT's phase-3 program in NASH.