MENLO PARK, Calif. - Corcept Therapeutics (NASDAQ:CORT) Incorporated (NASDAQ: CORT), a company specializing in the development of treatments for severe metabolic, oncologic, and endocrinologic disorders, today disclosed positive outcomes from the open-label phase of its Phase 3 GRACE trial. The trial evaluates relacorilant, a selective cortisol modulator, for patients with endogenous Cushing's syndrome.
During the open-label phase, 152 patients with either hypertension, hyperglycemia, or both were treated with relacorilant for 22 weeks. Results showed significant improvements in blood pressure and glucose metabolism, with 63 percent of hypertensive and 50 percent of hyperglycemic patients meeting the study's response criteria.
In detail, the trial noted a reduction in mean systolic blood pressure by 7.9 mm Hg and diastolic blood pressure by 5.4 mm Hg. For glucose metabolism, there was a decrease in mean hemoglobin A1C by 0.3 percent and fasting glucose by 12.4 mg/dL. These results were considered clinically meaningful and statistically significant, with p-values all less than 0.05.
Patients who demonstrated specific improvements were eligible to enter the double-blind withdrawal phase, where they either continued relacorilant treatment or received a placebo. The primary endpoint of this next phase is the maintenance of blood pressure control, with glycemic control as a key secondary endpoint.
Relacorilant's safety profile was consistent with previous findings, showing good tolerability and no significant adverse events related to the drug, including no cases of endometrial hypertrophy, adrenal insufficiency, or QT prolongation.
Richard Auchus, MD, PhD, expressed that the drug's unique mechanism of action could make relacorilant a new standard of care for Cushing's syndrome, given the marked improvements observed across various symptoms without a significant safety burden.
Corcept plans to present comprehensive data from both the open-label and randomized withdrawal phases at a medical conference in June and aims to submit a New Drug Application (NDA) within this quarter.
The information in this article is based on a press release statement from Corcept Therapeutics.
InvestingPro Insights
As Corcept Therapeutics (NASDAQ: CORT) continues to advance in its clinical trials, the financial health of the company remains a key consideration for investors. Corcept's management has been proactive in enhancing shareholder value, as evidenced by their aggressive share buyback strategy, which is an InvestingPro Tip that highlights the confidence of the company's leadership in its future prospects.
Moreover, Corcept holds a stronger liquidity position, with more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations. This financial stability is crucial as the company navigates the costly process of drug development and regulatory approvals.
From a valuation standpoint, Corcept's Market Cap stands at approximately $2.38 billion, with a Price-to-Earnings (P/E) Ratio of 24.41 and an adjusted P/E Ratio for the last twelve months as of Q4 2023 at 22.59.
While the company is trading at a high P/E ratio relative to near-term earnings growth, it's important to note that analysts predict the company will be profitable this year, a positive sign for potential investors. This profitability is further supported by a high Gross Profit Margin of 98.66% for the last twelve months as of Q4 2023.
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