Shares in Intercept Pharmaceuticals (NASDAQ: ICPT) got a shot in the arm in pre-open trading on Wall Street after the drug group secured regulatory approval for a liver drug.
The stock bounced US$13.11, or 9.25%, to US$154.88 on news that the FDA had granted accelerated approval to its Ocaliva treatment for primary biliary cholangitis (PBC).
Intercept plans to use Ocaliva, otherwise known as obeticholic acid, in tandem with ursodeoxycholic acid (UDCA) to treat patients who fail to respond to UDCA on its own.
It is expected to be available to PBC patients in the US within seven to 10 days and will be distributed through a specialty pharmacy network.
Chief executive Mark Pruzanski said: “Ocaliva’s approval marks the culmination of more than a decade of work.”
Intercept is hoping for big things from Ocaliva, given that UCDA is the only drug currently approved in the US to treat PBC.
It is also hoping to get it approved in Europe following the European Medicine Authority’s (EMA) acceptance last year of a marketing authorization application.
The EMA is reviewing the application and is due to publish its decision later this year.
There was speculation earlier this year that Intercept’s success with the drug could make it a takeover target.