NEW YORK, December 31, 2025, 13:58 ET — Regular session
- Corcept shares slid nearly 50% after the FDA issued a complete response letter for relacorilant in Cushing’s-related hypertension.
- The agency said it needs more evidence of effectiveness, delaying a key growth program beyond Korlym.
- Focus shifts to the company’s next steps with regulators and its separate ovarian cancer filing with a July 2026 FDA deadline.
Shares of Corcept Therapeutics Incorporated (CORT.O) sank nearly 50% on Wednesday after the U.S. Food and Drug Administration issued a complete response letter for the company’s relacorilant application in hypertension secondary to hypercortisolism, also known as Cushing’s syndrome. The stock was down 49.7% at $35.31 in afternoon trading. Nasdaq
The decision lands at a sensitive moment for investors who had been looking to relacorilant as the company’s next product story in Cushing’s beyond its marketed therapy. “FDA’s request for additional data may require additional trials, significantly dimming Corcept’s outlook in Cushing’s,” Truist analyst Joon Lee said. Reuters
The selloff cut Corcept’s shares from about $70 to the mid-$30s and erased roughly $3.7 billion in market value, Barron’s reported. The FDA action followed mixed late-stage data, with one Phase 3 trial meeting its main goal and a second missing its primary endpoint, the publication said. Barron’s
A complete response letter is the FDA’s way of saying it will not approve a drug application as submitted and wants the company to address specific gaps before it can reconsider.
Corcept said the FDA acknowledged its pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial provided confirmatory evidence. The agency nonetheless said it could not reach a favorable benefit-risk assessment without additional evidence of effectiveness.
Relacorilant is an oral selective glucocorticoid receptor antagonist — it blocks cortisol signaling while avoiding other hormone receptors, the company said. Hypercortisolism is long-term exposure to high cortisol activity, which can drive symptoms including high blood pressure and high blood sugar.
Corcept said it plans to meet with the FDA as soon as possible to discuss the best path forward. The company did not lay out a new timetable for resubmitting the application.
Corcept’s approved product Korlym is used to treat high blood sugar in adults with endogenous Cushing’s syndrome. Other medicines used in Cushing’s include Recordati’s Isturisa and Xeris Biopharma’s Recorlev.
Traders will be watching for any hint that the FDA is asking for a new pivotal study, and how quickly Corcept can generate the additional data. A repeat trial would extend timelines and raise development costs for a company whose commercial base has been concentrated in one franchise.
Corcept is also developing relacorilant in oncology, including platinum-resistant ovarian cancer and prostate cancer. For the ovarian cancer filing, the company said the FDA has set a July 11, 2026 user-fee deadline — known as the PDUFA date, the target date for an FDA decision — and that it recently filed a marketing application with European regulators.
The company said it is running advanced clinical trials in hypercortisolism, solid tumors, amyotrophic lateral sclerosis and liver disease. Near term, investors are likely to keep the spotlight on whether the Cushing’s-related hypertension program can get back on track.
Corcept shares touched a session low of $33 and had traded about 13.6 million shares by early afternoon, according to market data. The stock ended the prior session around $70.20.
Investors will be looking for any update after Corcept’s next interaction with the FDA, and whether management shifts attention toward the ovarian cancer program while it works through the hypercortisolism setback. Until then, the stock’s direction will likely hinge on how quickly the company can map a credible regulatory path for relacorilant.
