NEW YORK, December 31, 2025, 18:31 ET — After-hours
- Corcept shares slid about 50% after the FDA declined to approve relacorilant for hypertension secondary to hypercortisolism.
- The agency asked for more evidence of effectiveness, the company said, despite acknowledging key trial results.
- Analysts cut targets and one firm downgraded the stock as investors reassess the path to approval.
Corcept Therapeutics Inc shares sank about 50% in after-hours trading on Wednesday after the U.S. Food and Drug Administration declined to approve its oral drug relacorilant for a Cushing’s-related hypertension use. The stock was last at $34.80, down $35.39 from the prior close.
The decision hits at a key moment for Corcept, which investors have looked to relacorilant to expand the company’s business beyond its marketed drug Korlym. A regulatory setback for relacorilant raises the risk that Corcept’s next growth driver takes longer—and costs more—to reach the market.
Corcept said it received a complete response letter, the FDA’s notice that an application cannot be approved in its current form and that outlines what’s needed to move forward. The company said the agency could not reach a favorable benefit-risk assessment without additional evidence of effectiveness, even as it acknowledged results from Corcept’s GRACE and GRADIENT trials.
“FDA’s request for additional data may require additional trials, significantly dimming Corcept’s outlook in Cushings,” Truist analyst Joon Lee said. Reuters
Corcept sought approval for relacorilant to treat hypertension secondary to hypercortisolism, also known as Cushing’s syndrome. Hypercortisolism occurs when the body is exposed to high cortisol activity, a hormone pathway that can drive a range of symptoms.
Relacorilant is a selective glucocorticoid receptor antagonist designed to modulate cortisol activity while avoiding binding to other hormone receptors, the company said. Corcept said it plans to meet with the FDA to discuss next steps.
Other approved treatments for Cushing’s syndrome include Recordati’s Isturisa and Xeris Biopharma’s Recorlev, Reuters reported.
Wall Street moved quickly to reprice the regulatory risk. Wolfe Research downgraded Corcept to Underperform from Peer Perform and set a $30 price target, The Fly reported.
Truist, while keeping a buy rating, cut its price target on Corcept to $50 from $135, The Fly reported.
The stock swung sharply on the day, trading between $33.00 and $70.01, with about 20.3 million shares changing hands, according to market data.
Investors are now watching for clues on whether the FDA is looking for a new trial and what proof it would accept to clear an approval in hypertension tied to hypercortisolism. Corcept said the agency’s request centered on effectiveness, despite acknowledging the company’s pivotal and confirmatory trial data.
Corcept pointed to other relacorilant milestones still on the calendar, including a July 11, 2026 PDUFA date for relacorilant in platinum-resistant ovarian cancer. The company also said it recently submitted a marketing authorization application to the European Medicines Agency for that ovarian cancer indication.
With U.S. markets closed Thursday for the New Year’s holiday, the next regular session will be Friday. Technical traders will likely watch whether Corcept holds Wednesday’s low near $33, a level that marked the day’s floor after the stock broke sharply below its prior close near $70.
