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ICPT

Intercept

$98.12

1.92 (2.00%)

14:49
09/21/17
09/21
14:49
09/21/17
14:49

Citi calls FDA communication 'new negative' for Intercept shares

Citi analyst Joel Beatty views the FDA's safety communication today on Ocaliva as a "new negative" for shares of Intercept Pharmaceuticals. The communication included additional details beyond what Intercept included last week in its letter to doctors, Beatty tells investors in an intraday research note. A "notable positive," however, is that the FDA did not accompany the communication with a label change or black box warning, the analyst adds. He sees today's development as increasing investor concern over whether Ocaliva will get a black box warning. The analyst continues to think such a warning is a not a given, but does believe the safety communications will hurt the drug's competitiveness in nonalcoholic steatohepatitis. Beatty has a Buy rating on Intercept with a $150 price target. The stock in afternoon trading is down 18%, or $17.98, to $80.14.

ICPT Intercept
$98.12

1.92 (2.00%)

09/21/17
LEER
09/21/17
NO CHANGE
LEER
Market Perform
FDA could tilt toward black box warning for Intercept's Ocaliva, says Leerink
Leerink analyst Joseph Schwartz noted the FDA issued a new warning letter about liver injury risk with Intercept's Ocaliva that echoes much of the same content as the last week's "Dear Doctor" letter, but includes a warning that pertains to a larger portion of PBC patients. The FDA's mention of 19 deaths and worsening of PBC cases is "particularly concerning" and could tilt it toward a black box warning for the drug, added Schwartz. The analyst, who thinks Ocaliva adoption in PBC patients could face headwinds from safety issues, keeps a Market Perform rating on Intercept shares, which are down about 9% near noon.
09/21/17
JEFF
09/21/17
NO CHANGE
Target $275
JEFF
Buy
Intercept selloff on FDA communication overblown, says Jefferies
09/21/17
09/21/17
NO CHANGE

FDA communication on Intercept drug 'largely old news,' says Jefferies
09/21/17
JEFF
09/21/17
NO CHANGE
Target $275
JEFF
Buy
Jefferies says Intercept selloff overblown, news is 'largely old'
Jefferies analyst Michael Yee believes the details in today's FDA communication on Ocaliva are largely in line with what was highlighted last week in Intercept Pharmaceuticals' safety patient letter to doctors. "Big picture, this is largely old news and already known," Yee tells investors in an intraday research note. The stock in afternoon trading is down is down $14.18, or nearly 15%, to $83.94. The risk/benefit of Ocaliva still "clearly favors" its use in primary biliary cholangitis patients that have a lack of alternative treatment options, the analyst contends. He views today's stock pullback as overdone and recommends buying Intercept at current share levels. Yee argues the stock currently ascribes no value to the "much larger and valuable" Phase III nonalcoholic steatohepatitis program. The analyst has a Buy rating on the shares with a $275 price target.

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AIDIF

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