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ICPT

Intercept

$98.12

1.92 (2.00%)

11:29
09/21/17
09/21
11:29
09/21/17
11:29

Intercept sinks after FDA safety communication cites 19 patient deaths

The FDA, in its safety communication sent out today on Intercept Pharmaceuticals' Ocaliva, said it identified 19 cases of death, of which eight provided information about the cause. Intercept on September 12 told Bloomberg that 10 patients died while taking Ocaliva. In the 13 months after Ocaliva was approved in May 2016, the FDA says it received reports of serious liver injury or death associated with the drug. The cause of death was reported to be worsening of primary biliary cholangitis disease in seven cases, with cardiovascular disease cited in the other case. Seven of these eight cases described patients with moderate to severe decreased liver function who received Ocaliva 5 mg daily, instead of a dose no greater than 10 mg twice weekly as recommended in the label prescribing information for patients with this extent of decreased liver function, the agency said in its communication. Shares of Intercept are down 7%, or $6.72, to $91.40 in late morning trading.

ICPT Intercept
$98.12

1.92 (2.00%)

09/14/17
OPCO
09/14/17
NO CHANGE
Target $15
OPCO
Outperform
Intercept Ocaliva dynamics highlight PBC opportunity, says Oppenheimer
Oppenheimer analyst Jay Olson says the Dear Doctor letter for Intercept's (ICPT) Ocaliva raises awareness of unmet medical need for patients with primary biliary cholangitis, or PBC. Since patients with Child-Pugh B/C cirrhosis were not studied in Ocaliva trials, the analyst believes the FDA's collaboration with Intercept to leverage PK modeling for dosing guidance which is included in the label and emphasized in the Dear Doctor letter highlights the importance of providing novel treatments to PBC patients. Olson expects these events to have a positive impact on the treatment of all PBC patients, and says CymaBay (CBAY) may benefit from these dynamics. He reiterates an Outperform rating and $15 price target on CymaBay's shares.
09/14/17
RBCM
09/14/17
INITIATION
Target $244
RBCM
Outperform
Intercept initiated with an Outperform at RBC Capital
RBC Capital analyst Brian Abrahams started Intercept Pharmaceuticals with an Outperform rating and $244 price target. After speaking to physicians, the analyst believes Ocaliva's prospects in cholestatic disease are underappreciated and the drug's long-term potential in nonalcoholic Steatohepatitis "could be substantial." He views the stock as "meaningfully undervalued."
09/19/17
SBSH
09/19/17
NO CHANGE
Target $150
SBSH
Buy
Concern over Intercept 'Dear Doctor' letter overblown, says Citi
After finding 10 other drugs that have been the subject of a "Dear Doctor" letter related to liver toxicity issues, Citi analyst Joel Beatty believes concern over Intercept Pharmaceuticals' patient safety letter on Ocaliva is overblown. The risk that Ocaliva will be withdrawn from the market is "very low," and the risk that the drug will get a black box warning isn't as much of a given as it first appear, Beatty tells investors in a research note. Further, he believes the drug can still be commercially successful even with a black box warning. The analyst keeps a Buy rating on Intercept with a $150 price target.
09/20/17
JEFF
09/20/17
NO CHANGE
Target $275
JEFF
Buy
Intercept recent pullback a buying opportunity, says Jefferies
After hosting investor meetings with management, Jefferies analyst Michael Yee says the recent pullback in shares of Intercept Pharmaceuticals creates a buying opportunity. The analyst left the meetings more confident that the Street's reaction to the patient safety letter "was overblown and likely to subside." The stock is near a "floor valuation" of $80-$100 and gives no credit to nonalcoholic steatohepatitis in 2019, Yee tells investors in a research note. He keeps a Buy rating on Intercept with a $275 price target.

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