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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): January 15, 2020

 

 

 

Intercept Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware

(State or Other Jurisdiction

of Incorporation)

001-35668

(Commission

File Number)

22-3868459

(IRS Employer

Identification No.)

 

10 Hudson Yards, 37th Floor

New York, NY 10001

(Address of Principal Executive Offices and Zip Code)

 

Registrant’s telephone number, including area code: (646) 747-1000

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

  ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

  ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, par value $0.001 per share   ICPT   Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

  

Item 8.01.Other Events.

  

On December 13, 2019, Intercept Pharmaceuticals, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) had notified the Company that it was tentatively scheduling an advisory committee meeting relating to the Company’s New Drug Application (“NDA”) for obeticholic acid in liver fibrosis due to NASH for April 22, 2020. Given that this tentative date for the advisory committee meeting would take place after the previously announced March 26, 2020 Prescription Drug User Fee Act (“PDUFA”) target action date, the Company anticipated that the FDA would notify it of an extension to the PDUFA target action date.

 

On January 15, 2020, the FDA notified the Company that, pursuant to a major amendment, the FDA has extended the PDUFA target action date to June 26, 2020. This typical three-month extension provides the time needed to accommodate the advisory committee meeting and for the FDA to complete its review of the Company’s NDA, including additional information provided in response to FDA requests.

 

 

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  INTERCEPT PHARMACEUTICALS, INC.
     
     
  By: /s/ Sandip Kapadia
    Name:  Sandip Kapadia
    Title:    Chief Financial Officer and Treasurer

 

Date: January 17, 2020