FDA OKs Intercept’s NDA for obeticholic acid; shares up 5% premarket

Under Priority Review status, the FDA has accepted Intercept Pharmaceuticals’ (NASDAQ:ICPT) NDA for obeticholic acid (OCA) seeking approval for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH).

PDUFA target action date of March 26, 2020.

In the NDA filing acceptance letter, the FDA also indicated that it currently plans to hold an advisory committee meeting to discuss the application.

Shares are up 5% premarket.

https://seekingalpha.com/news/3521756-fda-oks-intercept-s-nda-obeticholic-acid-shares-5-percent-premarket