NEW YORK, January 1, 2026, 3:46 PM ET — Market closed.
- Corcept Therapeutics shares closed down 50.4% on Dec. 31 after the FDA issued a complete response letter for relacorilant in hypercortisolism-related hypertension.
- Wolfe Research downgraded the stock to Underperform with a $30 target after the regulatory decision, while other analysts said more trials may be needed.
- Investors are now watching for details from Corcept’s next FDA meeting and a separate mid-2026 decision date for relacorilant in ovarian cancer.
Corcept Therapeutics (CORT.O) shares ended the last U.S. session down 50.4% at $34.80 after the Food and Drug Administration declined to approve the company’s drug relacorilant for a rare hormonal-disorder-related blood-pressure condition.
U.S. stock markets are closed on Thursday for New Year’s Day, leaving investors to digest the regulatory setback before trading resumes on Jan. 2.
The decision matters because relacorilant was pitched as Corcept’s next growth driver beyond its existing Cushing’s franchise, and the FDA’s action resets expectations for when — or whether — the drug can reach the market in this indication.
A complete response letter is the FDA’s notice that it cannot approve a marketing application in its current form and lays out what the company must address to move forward.
Corcept said the FDA concluded it could not reach a favorable benefit-risk assessment for relacorilant without additional evidence of effectiveness, even though the agency acknowledged the pivotal GRACE trial met its primary endpoint and the GRADIENT trial offered confirmatory evidence.
In an SEC filing, the company said it issued a press release about the FDA letter and attached it as an exhibit.
Trading was briefly halted for “news pending” early on Dec. 31 and resumed at 8:20 a.m. ET, according to NYSE trade-halt data. New York Stock Exchange
Corcept traded as low as $32.99 and finished the day with about 20.3 million shares changing hands, far above the prior session’s volume.
“FDA’s request for additional data may require additional trials, significantly dimming Corcept’s outlook in Cushings,” Truist analyst Joon Lee said. Reuters
Wolfe Research downgraded Corcept to Underperform from Peer Perform and set a $30 price target, saying the company would likely need another lengthy trial and that the firm removed potential Cushing’s sales for relacorilant from its model.
Corcept already sells Korlym for certain patients with endogenous Cushing’s syndrome, while other treatments in the market include Recordati’s Isturisa and Xeris Biopharma’s Recorlev.
Corcept is also developing relacorilant in oncology, and the company said the FDA has set a July 11, 2026 target action date for relacorilant in platinum-resistant ovarian cancer.
Before the next session, investors will be looking for any signal on how quickly Corcept can get clarity from the FDA on what “additional evidence” means — another clinical trial, a new analysis plan, or other data — and whether the company updates its regulatory timeline. Nasdaq
Technically, traders will be watching whether the stock holds above Wednesday’s low near $33, with Wolfe’s $30 target in view, and whether it can reclaim the day’s high near $39 after the steep two-day slide.
Macro-wise, U.S. markets head into early-January data that can move risk appetite, including the December employment report and inflation readings that are scheduled for later in the month, according to the Labor Department’s release calendar updates.
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