FDA sets December 30, 2025 PDUFA date for Corcept drug

REDWOOD CITY, Calif. - Corcept Therapeutics (NASDAQ:CORT) Incorporated (NASDAQ: CORT), a $6.18 billion market cap company specializing in the development of treatments for severe endocrinologic and metabolic disorders, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for relacorilant. The company, which has delivered an impressive 151.79% return over the past year according to InvestingPro data, continues to show strong momentum in its drug development pipeline. This drug is intended for patients with endogenous hypercortisolism, also known as Cushing’s syndrome.

The NDA submission is supported by findings from the pivotal GRACE trial, along with corroborating results from the Phase 3 GRADIENT trial, a long-term extension study, and a Phase 2 trial in hypercortisolism. According to the company, patients treated with relacorilant showed improvements in various symptoms of hypercortisolism and the drug was well-tolerated. Notably, the trials reported no instances of serious adverse events commonly associated with current treatments, such as adrenal insufficiency, hypokalemia, or QT prolongation, nor any adverse events tied to progesterone receptor activity.

Joseph Belanoff, M.D., CEO of Corcept, expressed optimism about the FDA’s acceptance of the NDA, suggesting that relacorilant has the potential to become the new standard of care for those affected by Cushing’s syndrome. The company’s strong financial position, with a current ratio of 3.35 and minimal debt, positions it well for this potential market expansion. InvestingPro analysis reveals that Corcept maintains excellent financial health, with 13 additional ProTips available to subscribers.

Relacorilant is a selective cortisol modulator that targets the glucocorticoid receptor without affecting other hormone receptors. Corcept, which holds a portfolio of over 1,000 proprietary selective cortisol modulators, is investigating the potential of relacorilant in treating other serious conditions, including ovarian and prostate cancer. The drug has been granted orphan drug designation in both the United States and the European Union for the treatment of Cushing’s syndrome.

Cushing’s syndrome, caused by excessive cortisol activity, can lead to various health issues such as hypertension, obesity, elevated blood sugar, and severe fatigue. If not managed properly, the condition can be fatal.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025, for its decision on relacorilant. This information is based on a press release statement from Corcept Therapeutics. With revenue growth of 39.94% in the last twelve months and strong profitability metrics, investors seeking detailed analysis can access the comprehensive Pro Research Report available on InvestingPro, which provides in-depth insights into Corcept’s valuation and growth prospects among 1,400+ top US stocks.

In other recent news, Corcept Therapeutics reported its Q4 2024 earnings, which fell short of analyst expectations. The company reported an EPS of $0.26, missing the forecasted $0.38, and revenue of $181.89 million, below the expected $198.05 million. Despite the quarterly shortfall, Corcept achieved a robust 40% year-over-year revenue increase, totaling $675 million for 2024, with net income rising by 33% to $141 million. The company maintains a strong cash reserve of $603 million as of the end of 2024. Looking forward, Corcept has set a revenue guidance of $900 to $950 million for 2025. Analysts from Piper Sandler and H.C. Wainwright have been active in discussions about the company’s future, particularly focusing on the potential of its drug relacorilant. Corcept is also expanding its market for hypercortisolism treatments and advancing its NDA submission for relacorilant, while facing ongoing operational challenges with pharmacy partners. Additionally, the company is involved in legal proceedings with Teva over patent disputes, which could impact its market position.

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