8-K
CORCEPT THERAPEUTICS INC false 0001088856 0001088856 2024-01-02 2024-01-02

 

 

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

January 2, 2024

Date of Report (date of earliest event reported)

 

 

Corcept Therapeutics Incorporated

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-50679   77-0487658

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

  (I.R.S. Employer
Identification No.)

149 Commonwealth Drive, Menlo Park, CA 94025

(Address of Principal Executive Offices) (Zip Code)

(650) 327-3270

Registrant’s telephone number, including area code

Not Applicable

(Former name or former address, if changed since last report.)

 

 

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 (see General Instruction A.2. below):

 

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, $0.001 par value   CORT   The Nasdaq Stock Market

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

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 January 2, 2024, Corcept Therapeutics Incorporated (“Corcept”) issued a press release announcing that the Court for the District of New Jersey issued a decision that Teva Pharmaceuticals does not infringe any asserted claims of Corcept’s U.S. Patents 10,195,214 and 10,842,800, both of which concern methods of safely administering Korlym® with drugs that are strong CYP3A4 inhibitors.

The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01.

Financial Statements and Exhibits

(d) Exhibits

 

Exhibits
No.
   Description
99.1    Press Release dated January 2, 2024
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


SIGNATURE

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.

 

    CORCEPT THERAPEUTICS INCORPORATED
Date: January 2, 2024     By:  

/s/ Atabak Mokari

    Name:   Atabak Mokari
    Title:   Chief Financial Officer
EX-99.1

Exhibit 99.1

 

LOGO   

CONTACT

Investor inquiries:

ir@corcept.com

Media inquiries:

CorceptCommunications@corcept.com

www.corcept.com

COURT FINDS CORCEPT THERAPEUTICS’ PATENTS NOT INFRINGED

MENLO PARK, Calif., (January 2, 2024) — Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncology, metabolism, and neurology disorders by modulating the effects of the hormone cortisol, today announced the Court for the District of New Jersey issued a decision that Teva Pharmaceuticals does not infringe any asserted claims of Corcept’s U.S. Patents 10,195,214 and 10,842,800, both of which concern methods of safely administering Korlym® with drugs that are strong CYP3A4 inhibitors.

“This disappointing decision is based on legal and factual errors we are confident will be reversed on appeal,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. “Our patents describe medical discoveries that have greatly expanded the therapeutic options available to patients suffering from Cushing’s syndrome, which is why the FDA added them to Korlym’s prescribing instructions. Doctors have followed these instructions and will continue to do so to safely treat patients. Failure to recognize the novelty and import of discoveries like these would fundamentally change the law, to the detriment of the many patients whom innovative companies seek to serve.”

“We will pursue our appeal vigorously,” added Dr. Belanoff, “and will continue to assert our intellectual property rights whenever they are infringed.”

About Corcept Therapeutics

For more than 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients across a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept’s advanced clinical trials are being conducted in patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis (ALS) and liver disease (NASH). In February 2012, the company introduced Korlym, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with Cushing’s syndrome. Corcept is headquartered in Menlo Park, California. For more information, visit Corcept.com.

Forward-Looking Statements

Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or


imply. These risks and uncertainties include, but are not limited to, those related to Korlym, including its clinical attributes, regulatory approvals, mandates, oversight and other requirements; the practices of physicians in prescribing Korlym, either as monotherapy or in combination with other drugs, the scope and protective power of our intellectual property and the outcome of any current or future legal proceedings, including our appeal of the Court’s decision in our litigation with Teva Pharmaceuticals. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website. We disclaim any intention or duty to update forward-looking statements made in this press release.