Corcept Therapeutics (CORT.US) saw its stock price plunge more than 46% on Wednesday, closing at $37.33. The sharp decline came after the company announced it had received a Complete Response Letter from the U.S. Food and Drug Administration (FDA), indicating its New Drug Application (NDA) was not approved. The application sought approval for the oral drug Relacorilant to treat secondary hypertension caused by Cushing's syndrome. The company stated that the FDA's letter confirmed that Corcept's pivotal GRACE clinical trial met its primary endpoint and that data from the GRADIENT trial was considered confirmatory; however, the regulator concluded that the existing data was insufficient to support a favorable benefit-risk assessment for the therapy, requiring additional evidence of effectiveness. In response, Corcept's CEO, Joseph K. Belanoff, expressed that the company was "surprised and disappointed by this outcome" and stated it would "meet with the FDA as soon as possible to discuss and determine the best path forward." Relacorilant is an oral selective glucocorticoid receptor antagonist; beyond its intended use for endogenous Cushing's syndrome, it is also under development for conditions such as ovarian cancer. This regulatory setback introduces further uncertainty into the drug's path to commercialization, with market attention now focused on subsequent communications with the FDA and the progression of any additional required studies.