CORT Stock Hits Highest Levels In 2026 – Cushing’s Syndrome Drug NDA Resubmission Extends 5-Session Rally

• The FDA expects to issue a Prescription Drug User Fee Act date six months after the date of our submission.
• The agency did not accept Corcept’s NDA in December 2025, stating that it needed additional proof of the drug’s effectiveness.
• Patients with the disorder often experience symptoms such as high blood pressure, obesity, elevated blood sugar, severe fatigue, muscle weakness, and type 2 diabetes.

Shares of Corcept Therapeutics (CORT) are trading at their highest levels in 2026 after the biotech firm revealed plans to resubmit its New Drug Application to the U.S. Food and Drug Administration for its Cushing’s syndrome treatment, reviving investor optimism nearly five months after the agency rejected its initial filing.

CORT shares rose more than 7% in Wednesday’s morning session, extending a five-day winning streak.

PDUFA Date Expected In Six Months

Corcept said it will resubmit the NDA in the coming weeks after positive talks with the FDA. Its investigational drug, Relacorilant, is being developed to treat patients with Cushing’s syndrome. Also known as hypercortisolism, the disorder is caused by excessive cortisol activity and can affect nearly every organ system in the body.

“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,” said CEO Joseph K. Belanoff.

In December, the FDA did not approve the NDA, stating that it needed additional proof of the drug’s effectiveness.

How Does Cushing’s Syndrome Affect Patients?

Patients with the disorder often experience symptoms such as high blood pressure, obesity, elevated blood sugar, severe fatigue, muscle weakness, and type 2 diabetes. Mental health-related symptoms, including anxiety, depression, irritability, and cognitive problems, are also common.

Corcept added that untreated hypercortisolism can be life-threatening, with cardiovascular complications remaining the leading cause of death among patients suffering from the condition.

What Do Retail Traders Think Of CORT?

Retail sentiment for CORT on Stocktwits remained in the ‘bearish’ territory over the past 24 hours.

One user pointed out that the PDUFA timeline suggests the company expects a Class 2 review, which is typically assigned to resubmissions with substantial new data. By comparison, a Class 1 review is usually reserved for minor changes and generally receives an FDA response within about two months.

CORT shares have shed around 27% so far this year.

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