MENLO PARK, Calif. - Corcept Therapeutics (NASDAQ:CORT) Incorporated (NASDAQ: CORT), a company focused on the development of drugs to treat severe metabolic, oncologic, and endocrinologic disorders, announced today that its phase 3 trial of relacorilant has met its primary endpoint. The trial, named GRACE, assessed the efficacy of relacorilant in patients with Cushing's syndrome, a condition characterized by excessive cortisol production.
Relacorilant, a selective cortisol modulator, showed statistically significant improvements in controlling hypertension and hyperglycemia during the initial open-label phase of the GRACE study.
Following this, a randomized, double-blind withdrawal phase was conducted, where patients who showed specific improvements were randomly assigned to continue with relacorilant or switch to a placebo for 12 weeks. The primary endpoint was the loss of blood pressure control, with relacorilant demonstrating effectiveness compared to placebo (odds ratio: 0.17; p-value: 0.02).
The safety profile of relacorilant was consistent with previous findings, showing good tolerability with no significant differences in side effects between the relacorilant and placebo groups during the randomized phase. Further details on the GRACE study will be presented at upcoming medical conferences in June, including the Endocrine Society annual meeting and the Heart in Diabetes conference.
Rosario Pivonello, MD, PhD, the Principal Investigator of the GRACE study, expressed optimism about the drug's potential, highlighting the clinically significant improvements in patients without a significant safety burden. Corcept's Chief Development Officer, Bill Guyer, PharmD, also noted the positive results as a significant step towards submitting a New Drug Application, which the company anticipates filing in the third quarter of this year.
Relacorilant has received orphan drug designation in both the United States and European Union for the treatment of Cushing's syndrome. Beyond this condition, Corcept is investigating the drug's potential in treating various cancers, including ovarian, adrenal, and prostate cancer.
This news is based on a press release statement from Corcept Therapeutics.
InvestingPro Insights
In light of Corcept Therapeutics Incorporated's (NASDAQ: CORT) recent success with the GRACE study for relacorilant, investors may find the company's financial health and stock performance metrics of particular interest. With a robust market capitalization of approximately $2.87 billion USD, the company stands as a significant player in the biopharmaceutical industry. Corcept's strategic financial management is underscored by its aggressive share buyback policy, as noted in one of the InvestingPro Tips. Additionally, the company's solid balance sheet is reflected in its possession of more cash than debt, providing a strong foundation for future growth and research endeavors.
The company's earnings outlook appears promising, with two analysts recently revising their earnings estimates upwards for the upcoming period, another valuable insight from InvestingPro Tips. This optimism is further supported by Corcept's impressive revenue growth over the last twelve months, reported at 26.51%, and an even more remarkable quarterly revenue growth of 38.95% for Q1 2023.
Investors may also take note of Corcept's attractive valuation metrics. The company is currently trading at a P/E ratio of 23.9 and a forward-looking PEG ratio of 0.81, indicating potential for growth relative to its earnings. These figures suggest that Corcept's stock could be undervalued considering its near-term earnings growth prospects.
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