Intercept Trading Halted Pre-FDA Adcomm NASH Decision

 Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that NASDAQ has halted trading of the company’s common stock.

The U.S. Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) is meeting today to review obeticholic acid (OCA) as a treatment for pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH). The Advisory Committee meeting is scheduled for 9:00 a.m. - 5:00 p.m. ET. The briefing materials can be found on the FDA website (click here).

As previously reported, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 22, 2023. The timeline for review of the NDA by the FDA remains subject to change.

Trading of the company’s common stock will resume at the discretion of NASDAQ.

https://www.biospace.com/article/releases/intercept-pharmaceuticals-stock-trading-halted-today-fda-advisory-committee-to-review-obeticholic-acid-as-a-treatment-for-pre-cirrhotic-fibrosis-due-to-nash/