FDA accepts Corcept Therapeutics (NASDAQ: CORT) NDA for relacorilant in ovarian cancer

Rhea-AI Filing Summary

Corcept Therapeutics filed a report stating that the U.S. Food and Drug Administration has accepted its New Drug Application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. This acceptance means the FDA has agreed to review the application for this potential new therapy.

Insights

Biopharma regulatory analyst

FDA acceptance begins formal review of relacorilant for ovarian cancer.

Corcept Therapeutics reports that the FDA has accepted its New Drug Application for relacorilant in platinum-resistant ovarian cancer. Acceptance confirms the filing is complete and starts the official regulatory review process, an important but early-stage milestone.

This step does not guarantee approval or commercial success. Future outcomes will depend on the FDA’s detailed assessment of the submitted clinical and safety data, which are not described here. Subsequent regulatory decisions will determine whether relacorilant can be marketed for this indication.

CORCEPT THERAPEUTICS INC false 0001088856 0001088856 2025-09-10 2025-09-10

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

September 10, 2025

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)		(Commission File Number)		(I.R.S. Employer Identification No.)

101 Redwood Shores Parkway, Redwood City, CA 94065

(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 LLC

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 September 10, 2025, Corcept Therapeutics Incorporated (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has accepted the Company’s New Drug Application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. 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 of Corcept Therapeutics Incorporated, September 10, 2025
104.1		Cover Page Interactive Data File - the cover page XBRL tags are 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: September 10, 2025				By:		/s/ Atabak Mokari
				Name:		Atabak Mokari
				Title:		Chief Financial Officer

FAQ

What did Corcept Therapeutics (CORT) announce in this 8-K filing?

Corcept Therapeutics announced that the U.S. Food and Drug Administration accepted its New Drug Application for relacorilant to treat platinum-resistant ovarian cancer, formally starting the FDA’s review of this potential new therapy for patients with limited treatment options.

What is relacorilant in Corcept Therapeutics’ (CORT) latest SEC filing?

Relacorilant is a Corcept Therapeutics drug candidate for treating patients with platinum-resistant ovarian cancer. The company reported that the FDA has accepted its New Drug Application, meaning regulators will now conduct a full review of the submitted clinical and safety data package.

What does FDA acceptance of Corcept’s relacorilant NDA mean for CORT?

FDA acceptance of Corcept’s relacorilant New Drug Application means the submission is complete and will undergo full review. It is an important regulatory milestone but not an approval, so commercial use and revenue potential still depend on future FDA decisions not described here.

Which indication is Corcept Therapeutics (CORT) targeting with relacorilant?

Corcept Therapeutics is targeting platinum-resistant ovarian cancer with relacorilant. The company disclosed that the FDA has accepted its New Drug Application for this indication, initiating regulatory review for patients whose disease no longer responds adequately to standard platinum-based chemotherapy treatments.

Where can investors read more about Corcept’s relacorilant announcement?

Investors can review Corcept’s detailed announcement in the press release attached as Exhibit 99.1 to the 8-K. The filing states that this press release, dated September 10, 2025, provides additional information about FDA acceptance of the relacorilant New Drug Application for ovarian cancer.