CORT's Dazucorilant Fails to Meet Goal in Neurologic Disorder Study

Core Insights - Corcept Therapeutics announced data from the phase II DAZALS study evaluating dazucorilant for treating amyotrophic lateral sclerosis (ALS) [1] - The study did not meet its primary endpoint, leading to a decline in Corcept's shares in pre-market trading [2] - Year-to-date, Corcept's shares have increased by 85%, contrasting with a 4.6% decline in the industry [3] Study Details - The DAZALS study was a double-blind, placebo-controlled trial assessing two doses of dazucorilant (150 mg and 300 mg) [1] - Patients treated with dazucorilant experienced significantly more gastrointestinal upset compared to the placebo group [4] - An open-label, long-term extension study will continue, with overall survival data expected in March next year [5] Regulatory and Pipeline Updates - The FDA has granted Fast Track Designation to dazucorilant for ALS treatment [7] - Corcept's lead pipeline candidate, relacorilant, is in phase III of the GRACE study for Cushing's syndrome [8] - An NDA for relacorilant in Cushing's syndrome is anticipated to be submitted shortly [10] Additional Studies - Relacorilant is also being evaluated in combination with other drugs for various cancer indications, including a phase III study for platinum-resistant ovarian cancer [11]