# EDGAR Filing Document

**Accession Number:** 0001270073
**File Stem:** 0001104659-23-004841
**Filing Date:** 2023-1
**Character Count:** 10486
**Document Hash:** 5a0cb87be4dfe2ba87f74c45686eac4b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-23-004841.hdr.sgml**: 20230119

**ACCESSION NUMBER**: 0001104659-23-004841

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230119

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230119

**DATE AS OF CHANGE**: 20230119

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** INTERCEPT PHARMACEUTICALS, INC.
- **CENTRAL INDEX KEY:** 0001270073
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 223868459
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-35668
- **FILM NUMBER:** 23535955

**BUSINESS ADDRESS:**
- **STREET 1:** 305 MADISON AVENUE
- **CITY:** MORRISTOWN
- **STATE:** NJ
- **ZIP:** 07960
- **BUSINESS PHONE:** 646-747-1000

**MAIL ADDRESS:**
- **STREET 1:** 305 MADISON AVENUE
- **CITY:** MORRISTOWN
- **STATE:** NJ
- **ZIP:** 07960

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** INTERCEPT PHARMACEUTICALS INC
- **DATE OF NAME CHANGE:** 20031113

?xml version="1.0" encoding="utf-8"?

**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 19, 2023

**Intercept Pharmaceuticals, Inc.**

(Exact name of registrant as specified in its charter)

<u>Delaware</u>   <u>001-35668</u>   <u>22-3868459</u> <br> (State or other jurisdiction (Commission (IRS Employer <br> of incorporation) File Number) Identification No.)

<u>305 Madison Avenue, Morristown, NJ 07960</u>

(Address of principal executive offices) (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:

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| | | |
|:---|:---|:---|
| &nbsp;&nbsp;Title of each class | &nbsp;&nbsp;Trading <br> Symbol(s) | &nbsp;&nbsp;Name of each exchange on which<br> registered |
| &nbsp;&nbsp;Common Stock, par value $0.001 per share | &nbsp;&nbsp;ICPT | &nbsp;&nbsp;Nasdaq Global Select Market |

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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 7.01 Regulation FD Disclosure.**

On January 19, 2023, Intercept Pharmaceuticals, Inc. issued a press release, which is attached as Exhibit 99.1 and incorporated by reference, announcing that the U.S. Food and Drug Administration (FDA) has accepted for filing its resubmission of its New Drug Application (NDA) for obeticholic acid (OCA) seeking accelerated approval for the treatment of patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH).

**Item 9.01 Financial Statements and Exhibits.**

(d) *<u>Exhibits</u>*.

Exhibit Number Description <br> [99.1](tm233889d1_ex99-1.htm) [Press Release](tm233889d1_ex99-1.htm) <br> 104 Cover Page Interactive Data File (embedded as Inline XBRL document)

The information in Item 7.01 and Exhibit 99.1 is being furnished, not filed.

**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.

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| | |
|:---|:---|
| INTERCEPT PHARMACEUTICALS, INC. | INTERCEPT PHARMACEUTICALS, INC. |
| By: | /s/ Jerome Durso |
| Name: | Jerome Durso |
| Title: | President and CEO |

---

Date: January 19, 2023

## Exhibit 99.1

**Exhibit 99.1**

![](tm233889d1_exx99-1img001.jpg)

 

**FDA Accepts Intercept's New Drug Application for OCA for the Treatment of Pre-Cirrhotic Liver Fibrosis Due to NASH**

*NDA is supported by robust NASH clinical development program, including two positive interim analyses from the Phase 3 REGENERATE study demonstrating OCA's improvement in liver fibrosis without worsening of NASH*

*PDUFA target action date set for June 22, 2023*

 

**MORRISTOWN, NJ, January 19, 2023** – Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted Intercept's New Drug Application (NDA) for obeticholic acid (OCA) seeking accelerated approval for the treatment of patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH).

FDA indicated that it considers this a complete, Class 2 resubmission and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 22, 2023 for the NDA. The timeline for the review of the NDA by FDA remains subject to change.

"This regulatory milestone brings us one step closer to reaching our goal of delivering the first available therapy for patients living with pre-cirrhotic fibrosis due to NASH – the most rapidly growing cause of liver transplantation in the U.S." said Jerry Durso, President and Chief Executive Officer of Intercept. "We believe OCA has the potential to become an important therapy given its strong and direct antifibrotic effect, and we look forward to continuing our work with FDA over the coming months as they review our NDA."

The NDA is supported by a robust body of evidence from the OCA NASH clinical development program, including two positive, interim 18-month analyses from the pivotal Phase 3 REGENERATE study in patients with pre-cirrhotic liver fibrosis due to NASH. In these analyses, OCA 25 mg consistently demonstrated double the response rate of placebo in reduction in liver fibrosis stage without worsening of any of the three histologic components of NASH, an endpoint consistent with FDA's draft guidance. Further, a detailed assessment of 2,477 patients in REGENERATE, including nearly 1,000 patients on study drug for at least four years, provides a well-characterized safety profile that is monitorable and manageable, and supports chronic administration of OCA.

**About the REGENERATE Study**

REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment) is an ongoing Phase 3, randomized, double-blind, placebo-controlled, multicenter, international study assessing the safety and efficacy of obeticholic acid (OCA) on clinical outcomes in patients with liver fibrosis due to NASH. A pre-specified interim analysis was conducted in 931 subjects who had a liver biopsy at Month 18 to assess the effect of OCA on liver histology as compared to baseline biopsies. REGENERATE is fully enrolled with 2,480 randomized participants and is expected to continue while collecting data on the incidence of clinical outcomes for verification and description of clinical benefit. The end-of-study primary endpoint will compare the impact of treatment group (placebo, OCA 10 mg or OCA 25 mg daily) on all-cause mortality and liver-related clinical outcomes, as well as on long-term safety.

**About Liver Fibrosis due to NASH**

Nonalcoholic steatohepatitis (NASH) is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death. Advanced fibrosis is associated with a substantially higher risk of liver-related morbidity and mortality in patients with NASH. There are currently no medications approved for the treatment of NASH.

**About Intercept**

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH) and severe alcohol-associated hepatitis (sAH). For more information, please visit <u>www.interceptpharma.com</u> or connect with the Company on Twitter and LinkedIn.

**Forward-Looking Statements**

This press release contains forward-looking statements ("FLS"), including regarding the timing of FDA review of our NDA; the prospects for FDA approval of our NDA; the results of our clinical studies; drug efficacy, safety, and tolerability; the commercial opportunity for our product candidate; and the prospects of our product candidate compared to potential competitors. Important factors could cause actual results to differ materially from the FLS. For example, the FDA could take longer than expected to review our NDA; our product candidate could not receive FDA approval in a timely manner or at all; the FDA could require us to provide additional information that is not timely or economical to provide; we could be unable to address to the satisfaction of the FDA the issues raised in its complete response letter of June 2020 responding to our earlier submission; there could be efficacy, safety, or tolerability concerns about our product candidate; our clinical studies could have problems; and our product candidate could have less commercial potential than anticipated or could be superseded by a competing product.

**Contact**

For more information about Intercept, please contact:

For investors:<br> Nareg Sagherian, Executive Director, Global Investor Relations

<u>investors@interceptpharma.com</u>

For media:<br> Karen Preble, Executive Director, Global Corporate Communications

<u>media@interceptpharma.com</u>