Apr 23, 2026
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
Apr 21, 2026
A securities class action alleges Corcept misled investors about the regulatory prospects for relacorilant. The suit cites an FDA Complete Response Letter, a 50.4% stock drop, and an April 21, 2026 lead plaintiff deadline.
Mar 26, 2026
The FDA has approved Lifyorli (relacorilant) plus nab-paclitaxel for platinum-resistant ovarian cancer based on trial data showing improved survival. Separately, the agency granted Breakthrough Therapy designation to Lilly's sofetabart mipitecan for the same condition, expediting development of the antibody-drug conjugate.
Mar 01, 2026
Corcept Therapeutics received an FDA Complete Response Letter denying approval of relacorilant for hypertension secondary to hypercortisolism, triggering a 44.76% stock decline and multiple securities class actions.
Sep 11, 2025
The FDA issued a Complete Response Letter for Corcept's relacorilant as a treatment for hypertension secondary to hypercortisolism, requesting additional evidence of effectiveness despite acknowledging positive trial results.