REDWOOD CITY, Calif. - Corcept Therapeutics (NASDAQ:CORT) Incorporated (NASDAQ: CORT), a pharmaceutical company with a market capitalization of $5.3 billion and impressive revenue growth of nearly 40% in the last twelve months, has announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for relacorilant, a treatment for patients with Cushing's syndrome, also known as endogenous hypercortisolism. According to InvestingPro analysis, the company maintains exceptional profitability with a 98.4% gross margin.
The submission follows positive outcomes from the GRACE trial and supporting results from Phase 3 GRADIENT, long-term extension studies, and a Phase 2 study in hypercortisolism. Patients treated with relacorilant have shown improvements in symptoms associated with hypercortisolism without experiencing serious adverse events commonly seen with current treatments, such as adrenal insufficiency, hypokalemia, or QT prolongation.
Relacorilant is a selective cortisol modulator that targets the glucocorticoid receptor, avoiding other hormone receptors. This specificity may contribute to its safety profile. The drug has received orphan drug designation in the United States and the European Union for the treatment of Cushing's syndrome.
Cushing's syndrome is a condition characterized by excessive cortisol, leading to a variety of health issues including high blood pressure, central obesity, and severe fatigue. It can be life-threatening if not treated effectively.
Corcept's CEO, Dr. Joseph Belanoff, expressed optimism about relacorilant's potential benefits for patients with hypercortisolism and the possibility of the drug becoming a standard of care in medical treatment. The market appears to share this optimism, with the stock delivering a remarkable 61.5% return over the past six months. InvestingPro subscribers have access to 14 additional expert insights about CORT's growth potential and market position.
Corcept Therapeutics has a history of developing cortisol modulators, with over 1,000 proprietary molecules discovered over 25 years. The company's portfolio includes treatments for serious disorders such as solid tumors and liver disease. Corcept introduced Korlym®, the first FDA-approved treatment for Cushing's syndrome, in February 2012.
The company's statement also contained forward-looking projections regarding relacorilant's efficacy, safety, potential regulatory approval, and commercial prospects. The company's strong financial health is reflected in its current ratio of 3.7, indicating robust liquidity to support its development initiatives. InvestingPro's comprehensive research report provides detailed analysis of CORT's financial stability and growth prospects, available alongside 1,400+ other top US stocks. However, it is important to note that these statements are not guarantees of future performance and are subject to risks and uncertainties.
This news is based on a press release statement from Corcept Therapeutics Incorporated.
In other recent news, Corcept Therapeutics Incorporated has seen several significant developments. The company reported a robust increase in third-quarter revenue to $182.5 million, marking a 48% year-over-year rise, and a net income of $47.2 million. Consequently, Corcept raised its full-year revenue guidance for 2024 to between $675 million and $700 million.
On the clinical front, Corcept's Phase 4 CATALYST study achieved its primary endpoint, showing that Korlym significantly improved blood sugar levels in patients with hypercortisolism and hard-to-control type 2 diabetes. However, the Phase 2 DAZALS study of dazucorilant did not meet its primary endpoint for patients with ALS, but survival data has led to the continuation of an open-label extension study.
Corcept is preparing to submit a New Drug Application for relacorilant, a treatment for Cushing's syndrome, backed by positive results from the GRACE and GRADIENT studies, as noted by InvestingPro. Despite ongoing litigation with Teva Pharmaceuticals over a generic version of Korlym, Corcept continues to strive towards its goal of becoming a $3 billion business in the coming years.
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