On Thursday, September 21, as of 3:26 p.m. EDT, Intercept Pharmaceuticals (NASDAQ:$ICPT) plunged 21%. What happened? Well, the fall began after the FDA released a safety announcement warning the public that when Intercept’s liver disease drug Ocaliva is dosed incorrectly, there is an increased risk of “serious liver injury and death.”
The FDA Announcement
The FDA’s announcement was made in response to 19 patient deaths that have been reported by users of Intercept’s Ocaliva drug. The drug was first approved for sale in May of last year. Additionally, there have been 11 other cases of serious liver injury that have been reported.
This announcement came right after a letter was sent out by Intercept’s Chief Medical Officer last week which urged providers to continue with the drug’s approved dosing schedule.
Taking into consideration the concerns surrounding Ocaliva – the company’s only marketed drug – it isn’t a total surprise to see Intercept’s shares getting slammed on Thursday.
What Does the Future Entail?
Even though Intercept’s management team seemed to calm investors’ nerves last week at an investor conference, Thursday’s update is definitely set to raise new concerns about Ocaliva’s safety.
While it is still a possibility Thursday’s tumble will prove to be an overreaction, the smart play is still to watch this story unfold from the sidelines, especially if you are interested in biotech investing.
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