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ICPT

Intercept

$79.64

-1.74 (-2.14%)

16:56
06/24/19
06/24
16:56
06/24/19
16:56

Intercept initiated with a Hold at Stifel

Stifel analyst Derek Archila initiated Intercept with a Hold rating and $89 price target. The analyst, who is not optimistic about Ocaliva's commercial viability in NASH, believes there are "too many unknown variables surrounding an Ocaliva adcom and its potential launch in NASH to own the stock here."

ICPT Intercept
$79.64

-1.74 (-2.14%)

06/13/19
RBCM
06/13/19
NO CHANGE
RBCM
RBC says recent worries about Intercept's accelerated approval 'unfounded'
RBC Capital analyst Brian Abrahams said that at an investor conference yesterday night Intercept's CEO said the company has communicated with the FDA since the agency released draft guidance on development of drugs to treat NASH with compensated cirrhosis. The CEO said, according to Abrahams, that the FDA offered definitive confirmation that histological endpoints can still form the basis of accelerated approval from the REVERSE study. The analyst, who said Wall Street may be "overlooking" this new update, points to the comments as added evidence that concerns about accelerated approval have been "unfounded."
06/06/19
RAJA
06/06/19
NO CHANGE
RAJA
Strong Buy
Door not completely closed for Intercept on F4 NASH accelerated approval, says Raymond James
Raymond James analyst Steven Seedhouse notes that he has discussed the FDA draft guidance for the development of drugs for treatment of NASH with compensated cirrhosis with Intercept management. The analyst believes that some details seem to leave open the possibility for accelerated approval in F4 NASH based on REVERSE, which is essentially predicated on written agreement that Intercept received from FDA prior to starting the REVERSE study that informed/informs the intention that REVERSE will serve as the basis for seeking initial U.S. and international marketing authorizations of OCA for the treatment of NASH patients with compensated cirrhosis. Seedhouse reiterates a Strong Buy rating on the shares.
06/06/19
BARD
06/06/19
NO CHANGE
Target $227
BARD
Outperform
Intercept weakness unwarranted after FDA guidance, says Baird
With Intercept shares down 6.5% to $78.92 in afternoon trading following the release of draft guidance from the FDA on development of drugs to treat NASH with compensated cirrhosis, Baird analyst Brian Skorney said the pullback was "unwarranted" and "silly." The guidance doesn't impact Intercept's primary market opportunity, which will specifically be in F2 and F3 NASH patients, said Skorney, who thinks the market is misinterpreting the risk here as applying to the primary NASH approval. The analyst, who believes the new guidance "has zero impact" on OCA approvability in F2/3 NASH, suggests buying the stock on weakness and keeps an Outperform rating and $227 price target on Intercept shares.
06/06/19
RAJA
06/06/19
NO CHANGE
Target $183
RAJA
Strong Buy
Raymond James questions accelerated 'F4 NASH' approval for Intecerpt
Raymond James analyst Steven Seedhouse noted that the FDA published new guidance on development of drugs to treat NASH with compensated cirrhosis, otherwise known as "F4 NASH," which is being studied in Intercept's ongoing REVERSE study. The guidance suggests to him that an interim analysis assessing improvement in fibrosis and other secondary histologic endpoints at 52 weeks may not be sufficient for accelerated approval, Seedhouse tells investors. However, he adds that he doesn't think this has any impact on accelerated approval in non-cirrhotic NASH, which is the group being studied in the REGENERATE trial. Seedhouse keeps a Strong Buy rating and $183 price target on Intercept shares.

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MEOH

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SHIP

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SONM

Sonim

$13.42

0.24 (1.82%)

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