Corcept Therapeutics (NASDAQ:CORT) shares plunged Wednesday after the U.S. Food and Drug Administration (FDA) rejected its New Drug Application (NDA) for relacorilant, a treatment for hypertension caused by excessive cortisol levels.
The FDA’s Complete Response Letter (CRL) acknowledged that Corcept's pivotal GRACE trial met its primary endpoint—showing that relacorilant significantly improved blood pressure control compared to a placebo.
The Agency also noted that the GRADIENT trial provided confirmatory evidence.
However, regulators concluded they could not approve the drug without "additional evidence of effectiveness," effectively stalling the company's effort to move beyond its sole commercial product, Korlym.
Relacorilant is a selective glucocorticoid receptor (GR) antagonist designed to modulate the activity of cortisol, the "stress hormone," without the off-target effects of earlier therapies.
Unlike Korlym (mifepristone), which binds to progesterone receptors and can cause endometrial thickening or irregular bleeding, relacorilant was designed to be highly specific.
The rejection is a major blow to the Redwood City-based biotech, which had been banking on relacorilant to diversify its revenue stream as Korlym faces potential generic competition in the coming years.