On December 31, 2025, Corcept Therapeutics received a complete response letter from the U.S. Food and Drug Administration declining approval of relacorilant, its oral glucocorticoid receptor antagonist for hypertension secondary to hypercortisolism (Cushing’s syndrome). Although the FDA acknowledged the drug met its primary endpoint—a statistically significant reduction in systolic blood pressure compared with placebo at week 12—the agency determined that additional evidence of effectiveness was required to establish a favorable benefit-risk profile. The rejection halted the company’s year-end momentum and triggered a seismic market reaction.

Following the FDA communication, Corcept’s share price collapsed by just over 50% in a single trading session. The stock traded as low as $32.99 before settling near $34.80, wiping out roughly $3.7 billion in market capitalization and leaving the company with a valuation around $7.4 billion. Trading volume spiked to 20 million shares, nearly 22 times the three-month average of 896,000 shares, as institutional and retail investors reassessed the viability of Corcept’s lead candidate.

Management pledged to engage promptly with FDA officials to chart a path toward resubmission, but cautioned that new randomized controlled trials would likely be necessary to satisfy regulators’ calls for more robust efficacy data. Any such studies could extend development timelines by 18 to 24 months and require an estimated $100 million to $150 million in incremental R&D spending. Analysts note that relacorilant’s delayed approval would also impact peak sales projections—previously estimated at $800 million annually—raising questions about Corcept’s near-term revenue trajectory.