Corcept’s relacorilant was rejected for hypercortisolism late last year—a decision which CEO Joseph Belanoff expressed surprise with at the time.
On New Year’s Eve last year, the FDA turned down Corcept Therapeutics’ oral glucocorticoid receptor agonist relacorilant for the treatment of hypercortisolism, a verdict the biotech said at the time was surprising. But in its complete response letter, made public Friday, the agency said it had flagged issues with the application package early on.
At $39.87, Corcept shares closed Friday’s trading session down more than 10% from its previous closing price of $44.61.
“During the pre-submission meetings, we informed you on several occasions of our concerns about the adequacy of the clinical development program to assess the effect of relacorilant on hypertension in the intended population,” the FDA wrote.
The agency also warned Corcept that the company could “expect significant review issues” if it were to submit its application.
Corcept backed relacorilant with data from the Phase III GRACE and GRADIENT trials. Data released in May 2024 from the GRACE study showed the drug aced its key endpoint, inducing a significant improvement in blood pressure control versus placebo.
While the FDA recognized this late-stage success, it also noted in its rejection letter that “the analysis was conducted in a highly enriched population” and could have overestimated the effect of relacorilant in its intended patient population.
Corcept also submitted confirmatory evidence from GRADIENT, which the FDA said did not meet its primary endpoint.
Compounding Corcept’s problems were cases of drug-induced liver injury detected by the regulator. And while none of these instances were classified as severe, four were deemed probably linked to relacorilant. “Based on the currently available information, we cannot conclude that relacorilant has a favorable benefit risk assessment for the proposed indication,” the FDA wrote.
Moving forward, Corcept will need to generate “new clinical data” to support the efficacy of relacorilant in patients with hypercortisolism and establish that its safety risks do not outweigh its therapeutic benefits. The FDA also recommends coming up with a liver injury risk mitigation strategy.
It is unclear if Corcept is willing to run additional studies to support relacorilant’s application, though CEO Joseph Belanoff said in a statement alongside the rejection that the company is “confident we will find a way to get relacorilant to the patients it could help.”
