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FDA修改激素失调治疗拒绝信，取消审查
2026-01-30 22:19
- Corcept Therapeutics (CORT) lost ~16% in the premarket on Friday after the FDA revised a Complete Response Letter issued last month in connection with the company’s marketing application for its hormonal disorder therapy relacorilant.
- The agency declined to approve the New Drug Application filed by the Redwood City, California-based pharma, noting it could not determine a favorable benefit-risk assessment for the drug without additional data, according to a company press release in December.
- The NDA was aimed at seeking U.S. approval of relacorilant for patients with high blood pressure related to a hormonal disorder called hypercortisolism (Cushing's syndrome).
- In the partially redacted letter dated Jan. 28, the FDA noted that while the prior CRL contained no errors, it “is being updated to respond to Corcept’s communication.”
More on Corcept Therapeutics
- Why Corcept Therapeutics' Relacorilant Fell Short And What It Means For The Company
- Corcept: Korlym Defies Generics As Relacorilant Hits An FDA CRL (Rating Upgrade)
- Corcept Therapeutics: Despite FDA Blind Side, Relacorilant Remains A Viable Drug
- Corcept climbs as ovarian cancer therapy succeeds in late-stage trial
- Corcept sinks as FDA rejects hormonal disorder therapy
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