Overview
- The FDA acknowledged the GRACE trial met its primary endpoint and said GRADIENT provided confirmatory evidence but concluded more efficacy data are needed.
- Corcept said it will meet with the FDA to discuss next steps after calling the decision surprising and disappointing.
- In GRACE, adults with hypertension saw clinic blood pressure reductions of 7.9 mm Hg systolic and 5.1 mm Hg diastolic at 22 weeks.
- In GRADIENT, mean systolic blood pressure fell 6.6 mm Hg from baseline with relacorilant, though the change was not significantly different from placebo.
- Corcept Therapeutics shares fell about 41% in premarket trading following the Complete Response Letter.