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|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.
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