Corcept setback as relacorilant filing for hypercortisolism is rejected
US biotech Corcept Therapeutics (Nasdaq: CORT) said the American medicines regulator has issued a complete response letter rejecting its application for relacorilant in hypertension secondary to hypercortisolism, knocking the company’s shares down more than 50% earlier in the week.
The Food and Drug Administration (FDA) accepted that Corcept’s pivotal GRACE study met its primary endpoint and that confirmatory data from the Phase III GRADIENT trial supported the filing, but said it could not reach a favorable benefit-risk assessment without additional evidence of effectiveness.
“We are surprised and disappointed by this outcome,” said Joseph Belanoff, chief executive. “Our commitment to patients suffering from the effects of hypercortisolism is unwavering. I am confident we will find a way to get relacorilant to the patients it could help.”
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