© Reuters.

By Christiana Sciaudone

Investing.com — Intercept Pharmaceuticals Inc .  (NASDAQ:)shares tumbled 39%, to their lowest in seven years on Monday after the U.S. Food and Drug Administration said the benefits of its new liver disease drug are uncertain and don’t outweigh potential risks.

The FDA’s Complete Response Letter regarding Intercept’s new drug application for obeticholic acid (OCA) for the treatment of fibrosis due to nonalcoholic steatohepatitis requested additional post-interim analysis efficacy and safety data in support of potential accelerated approval.

“At no point during the review did the FDA communicate that OCA was not approvable on an accelerated basis, and we strongly believe that the totality of data submitted to date both meet the requirements of the Agency’s own guidance and clearly support the positive benefit-risk profile of OCA,” said Mark Pruzanski, the head of Intercept. “We are disappointed to see the determination the Agency has reached based on an apparently incomplete review, and without having provided medical experts and patients the opportunity to be heard at the anticipated Adcom on the merits of OCA.”

Intercept said it plans to meet with the FDA to discuss the letter and “discuss options for an efficient path forward to approval.”

Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures) and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn`t bear any responsibility for any trading losses you might incur as a result of using this data.

Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.

Source link