Exhibit 99.1
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CONTACT:
Investor inquiries:
ir@corcept.com Media
inquiries: communications@corcept.com
www.corcept.com |
FDA FILES CORCEPTS NEW DRUG APPLICATION FOR RELACORILANT AS
TREATMENT FOR PATIENTS WITH HYPERCORTISOLISM
FDA assigns a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025
REDWOOD CITY, Calif., (March 3, 2025) Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the
discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the U.S. Food and Drug Administration (FDA) filed its New
Drug Application (NDA) submission for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous hypercortisolism (Cushings syndrome).
Corcepts NDA is based on positive results from the pivotal GRACE trial and confirmatory evidence from the Phase 3 GRADIENT trial, long-term extension
trial, and a Phase 2 trial in hypercortisolism. Patients in these trials who received relacorilant experienced improvements in a wide array of hypercortisolisms signs and symptoms. Relacorilant was well tolerated. Notably, there were no
instances of drug-induced adrenal insufficiency, hypokalemia or QT prolongation serious adverse events that can arise in patients taking currently approved medications and no adverse events associated with activity at the progesterone
receptor, such as endometrial thickening or vaginal bleeding.
The FDAs acceptance of our New Drug Application takes us another step closer to
bringing relacorilant to patients with hypercortisolism, said Joseph Belanoff, M.D., Corcepts Chief Executive Officer. Relacorilants combination of efficacy and safety gives it the potential to become the new standard of care
for patients struggling with the devastating impact of this disease.
About Relacorilant
Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but not to the bodys other hormone receptors. Corcept is
studying relacorilant in a variety of serious disorders in addition to endogenous hypercortisolism (Cushings syndrome), including ovarian and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter,
method of use and other patents. Relacorilant has orphan drug designation in the United States and the European Union for the treatment of Cushings syndrome.