Candid reporter
Intercept Pharma (Nasdaq: ICPT) continued to decline on Wednesday after the Food and Drug Administration (FDA) issued briefing documents prior to the AdCom committee meeting regarding its marketing application for parent asset Obeticholic Acid (OCA) in NASH liver disease while Raymond James downgraded the stock, citing potential rejection.
Later this week, the Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee is scheduled to discuss the company’s New Drug Application (NDA) for OCA in nonalcoholic steatohepatitis (NASH). The farnesoid X receptor (FXR) agonist, brand name Ocaliva, is already approved in primary cholangitis (PBC).
Downgrading ICPT to Market Performance from Outperform Raymond James analyst Stephen Seidhouse expects the FDA to issue a full response letter indicating its disapproval of NASH by the time the agency finishes its review of the NDA by June 22.
However, the analyst stopped short of taking its rating to Underperform, citing the company’s PBC business, which, he says, provides “some bottom line for a rating.”
Seedhouse also notes that The Intercept’s (ICPT) plans to test a fixed-dose combination of OCA and bezafibrate for PBC will maintain its business model over a longer period of time than the company’s current models.
More about Intercept
- Objection to face FDA AdCom meeting about NASH candidate in May
- Objection: Potential huge positives with binary catalyst unlocking