Hypertension secondary to endogenous hypercortisolism (Cushing syndrome)
Key Notes
FDA issued a Complete Response Letter for relacorilant in hypercortisolism in late December 2025. The agency acknowledged the pivotal GRACE trial met its primary endpoint and that GRADIENT provided confirmatory evidence, but concluded it could not reach a favorable benefit-risk assessment without additional evidence of effectiveness. Corcept lead compound, separately approved as Lifyorli in ovarian cancer in March 2026. Source: Corcept press release (CRL, December 2025).
⚠️ Not Investment Advice: This information is provided for educational purposes only.
PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period,
issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on
historical base rates and do not account for drug-specific factors. Always consult a financial advisor
before making investment decisions.
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