Exhibit 99.1

  

 

 

Intercept Pharmaceuticals Reports 2015 Financial Results and Provides Business Update

 

NEW YORK, February 23, 2016

-- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today reported financial results for the fourth quarter and full year ended December 31, 2015 and provided other general business updates. Intercept will hold a conference call and audio webcast today at 8:00 a.m. Eastern Time to review this information with conference call details provided below.

 

Summary of Program Progress

 

·Primary Biliary Cirrhosis (recently renamed Primary Biliary Cholangitis [PBC]) Program

oCompleted NDA/MAA filings for PBC June 2015

oPriority Review granted by FDA August 2015

 

·Nonalcoholic Steatohepatitis (NASH) Program

oBreakthrough therapy designation granted from FDA for OCA in NASH with liver fibrosis in January 2015
oREGENERATE Phase 3 trial in non-cirrhotic NASH patients with liver fibrosis initiated September 2015
oCONTROL Phase 2 statin trial initiated December 2015

 

·Primary Sclerosing Cholangitis (PSC) Program

oAESOP Phase 2 trial continued enrollment

 

·Biliary Atresia Program

oCARE Phase 2 trial initiated October 2015

  

·INT-767 Program

oPhase 1 trial initiated November 2015

 

Planned 2016 Milestones

 

·PBC Program

oScheduled FDA Advisory Committee meeting April 7, 2016

oPDUFA date May 29, 2016 with planned US launch in June if NDA is approved

oAnticipated EU marketing authorization application decision in late 2016

 

·NASH Program

oContinued enrollment of REGENERATE and CONTROL trials

oPlanning of NASH cirrhosis and non-invasive technology trials

 

·INT-767 Program

oCompletion of Phase 1 trial and planning of Phase 2 trial

 


The following information was filed by Intercept Pharmaceuticals, Inc. (ICPT) on Tuesday, February 23, 2016 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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