FDA Rejects Relacorilant NDA Despite $559.3M YTD Revenues; Korlym Funds Trials

CORTCORT

Corcept reported $559.3 million in revenue over the first nine months of 2025 and $19 million in net income for Q3, driven by Korlym sales. The FDA rejected the NDA for relacorilant, citing insufficient benefit-risk evidence, but continued Korlym revenue underpins funding for additional trials.

1. CORT Posts Significant Intraday Surge on Volume

Corcept Therapeutics shares jumped 9.8% in the most recent trading session on volume that was approximately 45% above its 30-day average. The sudden move was driven by increased institutional participation, with nearly 1.8 million shares changing hands compared with a daily average of 1.2 million over the past month. Despite the price spike, analysts have revised their third-quarter earnings estimates downward by an average of 4%, citing rising R&D expenses and a slower uptake for pipeline candidates. Open interest in short positions declined by 12% over the past five trading days, suggesting some bearish bets were covered following the rally.

2. Korlym Revenues Provide Support Despite FDA Setback for Relacorilant

Corcept Therapeutics reported $559.3 million in Korlym revenue for the first nine months of 2025 and generated $19 million in net income during the third quarter. These figures establish a valuation floor as the company prepares for a resubmission of its Relacorilant NDA, which the FDA recently rejected due to insufficient benefit-risk evidence from pooled Phase 3 trials. Management has allocated 22% of third-quarter revenue toward pipeline development, leaving a cash runway of approximately 18 months at current burn rates. Investors will closely monitor upcoming investigator-initiated studies expected to read out in mid-2026, which may provide the additional efficacy data needed for regulatory approval.

Sources

ZS