The company said on Wednesday that the U.S. Food and Drug Administration has refused to approve Corcept Therapeutics’ drug for the treatment of a rare hormonal disorder. The drugmaker’s shares were 48 percent down at $36.41.
The company indicated that the FDA could not make a reasonable benefit-risk determination regarding the hormone-blocking oral therapy, known as relacorilant, unless Corcept could provide other evidence of its effectiveness.
Therefore, the company was seeking approval for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism.
Truist analyst Joon Lee stated that “FDA’s request for additional data may require additional trials, significantly dimming Corcept’s outlook in Cushings.”
Therefore, the Hypercortisolism or Cushing’s syndrome is a condition that arises when the body is exposed to high cortisol activity. Corcept had provided trial data that indicated that relacorilant had improved a broad range of the signs and symptoms of hypercortisolism.
Corcept’s CEO Joseph Belanoff added that “We will meet with the FDA as soon as possible to discuss the best path forward.”
However, the main symptoms of hypercortisolism include a fatty hump between the shoulders, a rounded face, and pink or purple stretch marks on the skin. Cushing’s patients also suffer from diabetes, high blood pressure, muscle weakness, and immune suppression.
Relacorilant is a selective cortisol modulator developed to block cortisol activity, but without some off-target hormonal effects.
Lee reported, “Given the company had opportunities to address FDA’s concerns during mid and late-stage reviews, it’s unclear if any further dialogue can resolve the review issues without additional trials.”
In addition, Corcept is conducting research on the drug in the treatment of various severe diseases such as ovarian and prostate cancer. Its other medication, named Korlym, is given to patients with high blood sugar levels due to hypercortisolism in adults with endogenous Cushing’s syndrome.
Thus, alternative treatments that have been approved to treat Cushing’s syndrome are Isturisa by Recordati and Xeris Biopharma Recorlev.
