MENLO PARK, Calif. - Corcept Therapeutics (NASDAQ:CORT) Incorporated (NASDAQ: CORT), a biopharmaceutical company focused on the development of drugs to treat severe medical disorders, has completed patient enrollment for its Phase 2 trial of dazucorilant, a drug aimed at treating amyotrophic lateral sclerosis (ALS). The trial, named DAZALS, is a randomized, double-blind, placebo-controlled study that has enrolled 249 patients across Europe, the United States, and Canada.
Patients in the DAZALS trial have been randomized to receive either 150 mg or 300 mg of dazucorilant, or a placebo daily for 24 weeks. The primary goal of the study is to measure the change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R), which evaluates motor function and the progression of disability in ALS patients. Additional key outcomes include overall survival rates and quality of life assessments.
ALS, commonly known as Lou Gehrig’s disease, is a fatal neurodegenerative condition that leads to muscle weakening and significant impairment in basic functions such as speech, eating, movement, and breathing. The disease currently affects over 25,000 individuals in the United States, with patients typically living two to five years after diagnosis. Elevated or abnormal cortisol levels have been observed in ALS patients, particularly in those with rapid disease progression.
Dazucorilant is a selective cortisol modulator that has shown potential in preclinical studies, including improved motor performance and reduced neuroinflammation and muscle atrophy in an animal model of ALS. The drug selectively binds to the glucocorticoid receptor (GR) and can cross the blood-brain barrier, which makes it a candidate for treating ALS and potentially other neurological disorders.
Corcept, which has been dedicated to the study of cortisol modulation for over 25 years, expects to report data from the DAZALS trial by the end of the year. The company has developed a portfolio of over 1,000 proprietary selective cortisol modulators and has previously brought to market Korlym, the first FDA-approved treatment for Cushing's syndrome.
The completion of enrollment in the DAZALS trial is a critical step towards understanding the potential of dazucorilant to improve outcomes for those living with ALS. This information is based on a press release statement.
InvestingPro Insights
Corcept Therapeutics Incorporated (NASDAQ: CORT) has demonstrated a commitment to both innovation in the medical field and strategic financial management. With a market capitalization of approximately $2.44 billion, the company is positioned as a significant player in the biopharmaceutical industry. One notable aspect of Corcept's financial strategy is the aggressive share buyback program, as highlighted by an InvestingPro Tip, which can often be interpreted as management's confidence in the company's future prospects and perceived undervaluation of the stock.
The company's balance sheet reflects a healthy financial status, holding more cash than debt, which is another InvestingPro Tip. This financial stability is crucial for Corcept as it invests in long-term research and development projects like the DAZALS trial for dazucorilant. Additionally, Corcept has been profitable over the last twelve months, and analysts predict it will remain profitable this year, which is reassuring for investors considering the high costs associated with clinical trials in the pharmaceutical industry.
From a valuation perspective, Corcept is trading at a Price/Earnings (P/E) ratio of 23.07 based on the last twelve months as of Q4 2023. While this indicates a premium relative to near-term earnings growth, the company's robust revenue growth of 20.04% over the same period suggests an underlying business strength. Investors should note that Corcept does not pay a dividend, directing its capital instead towards growth and research initiatives.
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