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由于FDA拒绝激素失调治疗，Corcept陷入困境
2025-12-31 21:38
- Corcept Therapeutics (CORT) fell ~35% in the premarket on Wednesday after the U.S. Food and Drug Administration (FDA) declined to approve its hormonal disorder therapy relacorilant, citing inadequate data.
- Issuing a Complete Response Letter in connection with the New Drug Application filed by the Redwood City, California-based pharma, the regulator has noted it could not finalize a favorable benefit-risk assessment for relacorilant without additional data on the drug’s effectiveness.
- The NDA was aimed at seeking U.S. approval for relacorilant as a treatment for patients with high blood pressure related to a hormonal disorder called hypercortisolism (Cushing's syndrome).
- “We are surprised and disappointed by this outcome,” Corcept’s (CORT) CEO Joseph Belanoff said, adding, “We will meet with the FDA as soon as possible to discuss the best path forward.”
More on Corcept Therapeutics
- Corcept Therapeutics Incorporated (CORT) Q3 2025 Earnings Call Transcript
- Corcept: Transition To New Specialty Pharmacy Well Underway
- Corcept anticipates $3B–$5B annual hypercortisolism revenue with relacorilant as FDA decisions near
- Corcept Therapeutics Q3 2025 Earnings Preview
- Seeking Alpha’s Quant Rating on Corcept Therapeutics
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