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Corcept Therapeutics Faces FDA Setback for Relacorilant Approval

Story Highlights
  • Corcept received an FDA Complete Response Letter for relacorilant’s application in hypertension due to hypercortisolism.
  • The setback delays U.S. approval for relacorilant in hypercortisolism but development continues, notably in ovarian cancer.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Corcept Therapeutics Faces FDA Setback for Relacorilant Approval

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Corcept Therapeutics ( (CORT) ) has shared an announcement.

On December 31, 2025, Corcept Therapeutics announced that the U.S. Food and Drug Administration issued a Complete Response Letter for its New Drug Application seeking approval of relacorilant to treat patients with hypertension secondary to hypercortisolism, despite the agency acknowledging that the pivotal GRACE trial met its primary endpoint and that the GRADIENT trial provided confirmatory evidence. The FDA concluded it could not yet make a favorable benefit-risk assessment without additional evidence of effectiveness, a setback that delays U.S. commercialization of relacorilant in hypercortisolism even as the company continues to advance the drug for other indications, including platinum-resistant ovarian cancer, where it has an FDA PDUFA decision date set for July 11, 2026 and a marketing application under review in Europe.

The most recent analyst rating on (CORT) stock is a Hold with a $95.00 price target. To see the full list of analyst forecasts on Corcept Therapeutics stock, see the CORT Stock Forecast page.

Spark’s Take on CORT Stock

According to Spark, TipRanks’ AI Analyst, CORT is a Outperform.

Corcept Therapeutics shows strong financial health and positive technical indicators, supporting a favorable outlook. However, high valuation and challenges highlighted in the earnings call, such as declining net income and patent litigation, temper the overall score.

To see Spark’s full report on CORT stock, click here.

More about Corcept Therapeutics

Corcept Therapeutics Incorporated (NASDAQ: CORT) is a commercial-stage biopharmaceutical company focused on discovering and developing medications that modulate the effects of the hormone cortisol to treat severe endocrinologic, oncologic, metabolic and neurologic disorders. Headquartered in Redwood City, California, Corcept has built a portfolio of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists, markets Korlym for endogenous hypercortisolism, and is conducting advanced clinical trials in hypercortisolism, solid tumors, ALS and liver disease.

Average Trading Volume: 895,583

Technical Sentiment Signal: Buy

Current Market Cap: $8.4B

For detailed information about CORT stock, go to TipRanks’ Stock Analysis page.

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