The FDA issued a rejection for Corcept Therapeutics' selective cortisol modulator relacorilant, denying approval for the treatment of Cushing’s syndrome. Corcept disclosed the decision and will assess next steps, including responding to the agency’s deficiencies or pursuing additional data. Regulatory detail: the company had sought approval based on clinical data demonstrating cortisol pathway modulation; the FDA’s rejection suggests concerns about efficacy, safety, or data sufficiency in meeting the agency’s benefit‑risk standard for the indication. Why it matters: the decision removes a near‑term commercial opportunity for Corcept and underscores persistent regulatory hurdles for cortisol‑targeting therapies in complex endocrine disorders.
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