Intercept Pharmaceuticals Shares Fall 13% After FDA Delays an Advisory Committee Meeting
Shares of Intercept Pharmaceuticals (NASDAQ: ICPT) were down 13% at 3 p.m. EDT on Friday after the company disclosed that the Food and Drug Administration plans to postpone an advisory committee meeting to review obeticholic acid as a treatment for liver fibrosis due to nonalcoholic steatohepatitis (NASH).
The meeting had been tentatively scheduled for June 9, but Intercept plans to submit additional data requested by the FDA within the next week, so the agency wants to push back the meeting to give itself time to review the additional data. The delay will likely cause the FDA to miss the agency's June 26 goal for completing its review of the marketing application.
By itself, the delayed approval, which shouldn't last more than a couple of months, doesn't justify a 13.6% decline in Intercept's valuation. But biotech investors are rightfully discounting the company's shares because the FDA requested additional data, which suggests that an approval isn't a slam dunk.
Source Fool.com
