Company Announcements

REDWOOD CITY, Calif.--(BUSINESS WIRE)--May 27, 2026-- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced it will resubmit its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for relacorilant as a treatment for patients with Cushing’s syndrome.

“Following issuance of its complete response letter, the FDA asked us to conduct additional analyses of our NDA data,” said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. “Based on the positive outcome of those analyses and the productive tenor of our discussions, we plan to resubmit our NDA in the coming weeks. The agency has told us to expect a Prescription Drug User Fee Act (PDUFA) date six months after the date of our submission. We appreciate the FDA’s continued engagement with our efforts to bring relacorilant’s benefits to patients with hypercortisolism.”

About Hypercortisolism (Cushing’s Syndrome)

Hypercortisolism, also known as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be fatal if not treated effectively. Cardiovascular events are the most common cause of death among patients with hypercortisolism. Recent research in patients with difficult-to-control diabetes and in patients with resistant hypertension shows that endogenous hypercortisolism is more prevalent than previously believed.

About Corcept Therapeutics

For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In 2012, the company introduced Korlym^®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous Cushing’s syndrome. In 2026, the company introduced Lifyorli™, approved in combination with nab-paclitaxel, the first FDA-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Corcept is headquartered in Redwood City, 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 and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements.

In this press release, forward-looking statements include statements concerning: our plan to resubmit our NDA to the FDA for relacorilant as a treatment for patients with Cushing’s syndrome; our expectation of a PDUFA date six months after the date of our NDA resubmission; and the FDA’s continued engagement with our efforts to bring relacorilant’s benefits to patients with hypercortisolism.

A further description of risks and uncertainties affecting our forward-looking statements can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to: our ability to operate our business; our efforts to study and develop Korlym, Lifyorli, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes; regulatory approvals, mandates, oversight and other requirements imposed on our products or our business by laws, regulations or discretion of government authorities; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.

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Source: Corcept Therapeutics Incorporated