US Stock Market Move | New drug application not approved by FDA, Corcep Medical (CORT.US) plummets over 46%.

On Wednesday, the stock price of Corcep Medical (CORT.US) dropped by over 46%, to $37.33. The company announced that they have received a complete response letter from the US Food and Drug Administration (FDA), stating that their new drug application has not been approved. The application was seeking approval for the oral medication Relacorilant for the treatment of secondary hypertension caused by hypercortisolism. The company stated that the FDA confirmed in the response letter that the key GRACE clinical trial met its primary endpoint, and that the GRADIENT trial data was confirmatory. However, the regulatory agency believed that existing data was still insufficient to support a favorable benefit-risk assessment of the treatment, and requested additional evidence of effectiveness. In response, Corcept CEO Joseph K. Belanoff expressed surprise and disappointment at the outcome, stating that the company will "meet with the FDA as soon as possible to discuss and determine the best path forward." Information shows that Relacorilant is an oral selective glucocorticoid receptor antagonist, being developed for indications related to endogenous hypercortisolism as well as diseases like ovarian cancer. The setback in approval means that the commercialization process of this drug will face further uncertainty, with the market focusing on subsequent regulatory communication and the progress of supplementary research plans.