Corcept Resubmits Relacorilant NDA for Cushing’s Syndrome After FDA Request — Corcept Therapeutics Incorporated

Event summary

Corcept Therapeutics resubmitted its New Drug Application (NDA) for relacorilant to treat Cushing’s syndrome on June 17, 2026, after FDA requested additional data analysis.
The resubmission includes data from the GRACE trial, GRADIENT trial, and long-term extension studies.
Corcept expects a six-month FDA review period for the resubmission.
Relacorilant is designed to avoid serious adverse events linked to existing Cushing’s syndrome treatments.

The big picture

Corcept’s resubmission of the relacorilant NDA reflects its strategic focus on expanding treatment options for Cushing’s syndrome, a condition with significant unmet medical needs. The FDA’s engagement and the six-month review timeline suggest a structured but potentially expedited path to approval. Success here could reinforce Corcept’s position in cortisol modulation therapies and support its broader pipeline of selective glucocorticoid receptor antagonists.

What we're watching

Regulatory Timing: Whether the FDA’s six-month review period will lead to approval and how quickly Corcept can commercialize relacorilant if approved.
Competitive Positioning: How relacorilant’s safety profile will differentiate it from existing Cushing’s syndrome treatments in the market.
Pipeline Progress: The pace at which Corcept advances other clinical trials, including those for solid tumors, ALS, and liver disease.