Overview
- Corcept disclosed the FDA’s Complete Response Letter for relacorilant for hypertension secondary to hypercortisolism.
- Regulators acknowledged the GRACE phase 3 trial met its primary endpoint but said the data do not yet justify approval.
- The GRADIENT study was cited as confirmatory evidence, though it showed no significant blood-pressure difference versus placebo.
- A long-term extension reported larger 24‑hour ambulatory blood-pressure reductions over 24 months in treated patients.
- Corcept said it will seek a meeting with the FDA to discuss next steps, as shares fell about 41% in premarket trading.