ICPT Intercept Pharmaceuticals Inc

By Colin Kellaher

Intercept Pharmaceuticals shares moved lower in premarket trading Monday after the biopharmaceutical company's latest setback in its bid to win U.S. Food and Drug Administration approval of obeticholic acid as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis, a chronic liver condition commonly known as NASH.

Shares of the Morristown, N.J., company, which closed Thursday at $13.56, were recently down 14% at $11.66 in premarket trading. Trading in the stock was halted all day Friday.

An FDA advisory committee meeting on Friday voted overwhelmingly that the drug's benefits don't outweigh its risks, and that the agency should defer approval under an accelerated pathway based on currently available data until data from an ongoing study are submitted and reviewed.

The FDA in 2020 rejected Intercept's initial application for obeticholic acid, saying the company's efficacy data didn't sufficiently outweigh potential risks.

Intercept conducted additional studies and resubmitted the application in December, seeking an accelerated approval. The agency has set a target action date of June 22 for a decision.

The FDA often relies on advisory committees to provide independent advice when a scientific, technical or policy question arises, such as whether an unapproved product is safe and effective, and the panels make non-binding recommendations that the agency generally follows, although it isn't legally bound to do so.

There are currently no FDA-approved products for NASH, a progressive disease that is a leading cause for the need for liver transplants.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

May 22, 2023 07:42 ET (11:42 GMT)

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