• By ICR Secretariat
  • Posted Monday, September 25, 2017

Intercept shares plummet on FDA warning

http://www.biopharmadive.com/news/intercept-shares-plummet-on-fda-warning/505594/

'The Food and Drug Administration has followed up Intercept Pharmaceuticals' "Dear Health Care Provider" letter with a drug safety communication concerning Intercept's Ocaliva, used to treat primary biliary cholangitis (PBC). This alert warns of increased risk of serious liver injury and death in patients with moderate to severe decreases in liver function who are given higher frequency doses than in the drug label. It also mentions cases of liver injury in patients with mild liver disease.
There have been 19 deaths; seven of these were in moderate or severe PBC patients with decreased liver function receiving 5 mg daily rather than the recommended 10 mg twice weekly. There were also 11 cases of serious liver injuries.
Much like previous sentiments, analysts continue to believe that the reaction from the market to these developments are overdone. An investor note from Jefferies sees this as simply reiterating what is already known, stating that the current stock reaction is "overblown."'

 

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