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Intercept Pharmaceuticals Inc.

www.interceptpharma.com

Latest From Intercept Pharmaceuticals Inc.

Keeping Track: Approvals For Phexxi, Kynombi; New Claims For Lynparza, Alunbrig, Tecentriq; Intercept May Miss NASH User Fee Date

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Intercept’s NASH Approval Timeline Shuffled Again With FDA Delay

The company said a planned 9 June advisory committee to review the NDA for obeticholic acid in NASH has been postponed a second time, which means OCA likely will not be approved by 26 June.

Drug Approval Standards Advisory Committees

RESOLVE-IT Failure Dashes Genfit's NASH Hopes

Genfit SA is now pinning its hopes for elafibranor on primary biliary cholangitis after the dual PPAR alpha/delta agonist failed in its Phase III RESOLVE-IT trial for NASH.

Clinical Trials Companies

Virtual Advisory Committees: Who Will Be First In Line To Test On-Line Meetings?

US FDA says it is preparing to hold ‘virtual’ advisory committee meetings amid the COVID-19 outbreak. Does anyone want to go first?

Advisory Committees Coronavirus COVID-19
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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
    Jason Campagna, MD, PhD, CMO
  • Contact Info
  • Intercept Pharmaceuticals Inc.
    Phone: (646) 747-1000
    10 Hudson Yards
    37th Fl.
    New York, NY 10001
    USA
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