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Intercept Pharmaceuticals Inc.

www.interceptpharma.com

Latest From Intercept Pharmaceuticals Inc.

New CEO At MorphoSys Seeking Partner For ‘CAR-T Killer’ Lymphoma Drug

Analysts tip Munich-based company for greatness, but it will need a big pharma partner to take on Roche's Polivy in competitive hemato-oncology market.

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Will A US FDA Advisory Committee Be In Intercept's Future?

There are strong reasons to justify an advisory committee meeting for the NASH application, but also an outlet for the US FDA to skip it.

Advisory Committees Drug Review

Intercept’s NASH NDA Positions OCA For May 2020 Approval, Then Launch

Intercept hopes to be first to market in NASH with an indication to treat fibrosis. It also is enrolling a study to show a benefit in NASH patients with cirrhosis.

Drug Approval Standards Clinical Trials

Intercept Could Face Tougher Road To NASH Approval In EU Than US

Recently filed NDA for obeticholic acid relies on US FDA's specified endpoints for treatment of fibrosis, but European standards are less clear cut, the company acknowledges.

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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Therapeutic Areas
  • Hepatic (Liver)
  • Metabolic Disorders
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Intercept Pharmaceuticals Inc.
  • Senior Management
  • Mark Pruzanski , MD, Pres. & CEO
    Sandip Kapadia, CFO
    David Shapiro, MD, CMO
    Jerome Durso, COO
  • Contact Info
  • Intercept Pharmaceuticals Inc.
    Phone: (646) 747-1000
    10 Hudson Yards
    37th Fl.
    New York, NY 10001
    USA
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