Intercept Pharma (NASDAQ:ICPT) shares are down almost 30% Monday after it announced the outcome of the US Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) meeting.
The meeting reviewed the company's New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH) and voted to defer an accelerated approval.
The FDA's GIDAC voted 12-2 (with 2 abstentions) against OCA 25 mg on the question of overall benefit-risk in NASH.
Advisory committee notes are not binding but are considered by the FDA when making a decision regarding the approval of an application.
Reacting to the news, H.C. Wainwright analysts said the firm has removed NASH entirely from its model. They downgraded ICPT to Sell and lowered the firm's price target on the stock to $8 per share.
"As expected, the focus of both the FDA briefing docs and the AdCom panelists was the potential for various serious safety risks (hepatoxicity/DILI events; renal tox/AKI events, CV risk; accelerated diabetes risk and increased pruritus), in light of the modest effect size in a surrogate endpoint," said the analysts. "The proposal of a REMS to contain the multitude of these safety risks was also largely panned by the panel as impractical and ineffective."