Changes in US stocks | New drug applications not approved by FDA Corcep Healthcare (CORT.US) plummeted by more than 46%

The Zhitong Finance App learned that on Wednesday, Corcep Healthcare (CORT.US) stock price plummeted by more than 46% to $37.33. According to the news, the company said it had received a full response letter from the US Food and Drug Administration (FDA), and its application for the new drug was not approved. The application seeks approval for the oral drug Relacorilant to treat secondary hypertension due to hypercortisolemia (hypercortisolemia).

According to the company, the FDA confirmed in its response letter that Corcept's key GRACE clinical trial reached a major endpoint and that GRADIENT trial data are verifiable; however, regulators believe that the existing data is still insufficient to support a favorable benefit-risk assessment of this treatment, and therefore requires additional evidence of efficacy.

In response, Corcept CEO Joseph K. Belanoff said the company was “surprised and disappointed with this result,” adding that it would “meet with the FDA as soon as possible to discuss and determine the best follow-up path.”

According to data, relacorilant is an oral selective glucocorticoid receptor antagonist. In addition to being used for endogenous hypercortisol-related indications, it is also being developed in ovarian cancer and other diseases. The delay in approval means that the commercialization process of the drug will face further uncertainty, and the market is concerned about the progress of follow-up regulatory communication and supplementary research plans.