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To: The Ox who wrote (3525)6/27/2014 10:36:41 AM
From: The Ox  Read Replies (1) | Respond to of 8250
 
Two "neutral" reports yesterday and a bullish response this morning on ICPT, fwiw:

Summer Street reiterated a Buy rating on Intercept Pharmaceuticals (NASDAQ: ICPT) with a price target of $650. Analyst Jim Molloy said potential breakthrough designation could overshadow dyslipidemia issues.

"ICPT shares traded off sharply again yesterday (down 7%) following confirmation that the OCA topline FLINT phase II data from the NIH is likely to be released in August, from July previously, due to data entry/data scrubbing at the NIH. We see no reason to change our thesis that OCA could be a game changer for treating NASH. We believe that there is good reason to believe that ICPT will seek the “breakthrough therapy” designation for NASH, which could allow an sNDA path in NASH on the basis of the Ph II NIH trial alone, without the need for confirmatory Ph III trials," said Molloy.

"We don’t believe that this is the most likely case, and we aren’t changing our expectations for a Ph III trial starting in 1H:15 and NDA filing 1H17. It is noteworthy that Ligand (LGND-$62.91-NR) recently followed a similar path for its Promacta (for severe aplastic anemia) sNDA in Feb;14 and just received a priority review designation in April:14. While the two drugs aren’t entirely comparable, the Promacta timeline is illustrative, in our opinion, of what the upside for the OCA filing could be if the FLINT data is as strong as we believe it could be," he added.