No biotech company wants to exit without being rebuffed by regulators. unfortunately Consip Therapeutics (NASDAQ:CORT) and its shareholders, that’s exactly what happened to the California-based company. As a result, the company’s stock price fell more than 50% in Tuesday’s trading.
That morning, Corcept announced that it had received a complete response letter from the U.S. Food and Drug Administration (FDA) in which the regulator declined to approve its relacorilant. This is a hormone-blocking oral medication that targets high blood pressure (i.e. hypertension) secondary to hypercortisolism.
This disorder, also known as Cushing’s syndrome, is a rare hormonal disorder in which the body is chronically exposed to cortisol, a stress hormone.
Corcept said that although the FDA acknowledged that the drug met its primary endpoint in a late-stage clinical trial, the regulator “cannot make a favorable benefit-risk assessment of relacorilant without additional evidence of effectiveness from Corcept.”
Corcept isn’t giving up on its once-promising drug. The company pledged to continue working to find ways to commercialize it and said it planned to meet with FDA officials in the near future to discuss potential directions for the drug.
However, any chance of success now will likely require additional clinical trials, so even in the best-case scenario, the drug won’t be easily approved. Therefore, the FDA’s response must be viewed as a major failure for Corcept.
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