Shots:
- The US FDA has issued a Complete Response Letter (CRL) to Corcept for the NDA of relacorilant for the treatment of hypertension secondary to hypercortisolism
- While the US FDA acknowledged that the pivotal P-III (GRACE) study met its 1EP and that data from the GRADIENT study provided supportive evidence, the Agency concluded that additional evidence of effectiveness is required to support a favorable benefit-risk assessment
- Corcept plans to engage with the US FDA to discuss next steps; relacorilant remains under development across multiple indications, including platinum-resistant ovarian cancer for which FDA assigned a PDUFA date of Jul’11, 2026 and the company recently submitted an MAA to the EMA for same indication
Ref: Corcept Therapeutics | Image: Corcept | Press Release
Related News: Corcept Therapeutics Reports the EMA’s MAA Submission of Relacorilant to Treat Platinum-Resistant Ovarian Cancer
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