Core Viewpoint - Corcept Therapeutics faces significant setbacks regarding its proposed treatment for hypercortisolism, relacorilant, following warnings from the FDA not to submit its drug application, leading to a sharp decline in share price [1][2]. Company Developments - On January 30, 2026, Corcept shares dropped by $7.81, or 17%, after reports of FDA warnings against submitting the drug application [1]. - The company's market capitalization has decreased by $3.2 billion since December 30, 2025, following the receipt of a complete response letter (CRL) from the FDA [4]. FDA Communications - The FDA had previously issued a CRL indicating that it could not arrive at a favorable benefit-risk assessment for relacorilant without additional evidence of effectiveness [3]. - A corrected CRL dated January 28 revealed that the FDA had warned Corcept on multiple occasions about significant review issues if the application was submitted [3]. Investor Concerns - Hagens Berman, a law firm, is investigating whether Corcept misled investors regarding relacorilant's efficacy and the company's communications with the FDA [2][4]. - The firm is also analyzing if Corcept overstated its commercial and growth prospects for the hypercortisolism business, which was projected to grow from $3 billion to $5 billion in annual revenues within three to five years [3].
Corcept Therapeutics (CORT) Shares Fall Again Amid Report FDA Warned Several Times Not to Submit Relacorilant Drug Application – Hagens Berman