NEW YORK, January 1, 2026, 04:13 ET — Market closed
- Corcept Therapeutics shares last closed down 50.4% at $34.80 after an FDA decision on relacorilant.
- The company said the regulator wants more evidence of effectiveness for the Cushing’s-related indication.
- Traders are watching for the company’s next steps with the FDA and fresh analyst revisions when U.S. markets reopen.
Corcept Therapeutics Incorporated shares last closed down 50.4% at $34.80 on Wednesday.
The selloff followed news that the U.S. drug regulator will not approve relacorilant in its current form for an expanded use tied to a rare hormonal disorder.
The decision matters now because relacorilant was the company’s near-term bid to broaden its cortisol-modulation franchise beyond its existing product line, and investors had been bracing for a pivotal regulatory readout into year-end.
A setback at the FDA can reset timelines and raise costs, forcing Wall Street to reprice pipeline-driven growth and push back revenue assumptions that were tied to a new label.
Corcept said the Food and Drug Administration issued a complete response letter — the agency’s notice that an application cannot be approved as filed — for its new drug application for relacorilant to treat high blood pressure caused by hypercortisolism. Chief Executive Joseph K. Belanoff said the company was “surprised and disappointed,” after the FDA asked for additional evidence of effectiveness, even as it acknowledged results from Corcept’s GRACE and GRADIENT studies. Business Wire
The company said it plans to meet with the FDA to discuss next steps, while continuing to develop relacorilant in oncology, including a U.S. decision date of July 11, 2026 for platinum-resistant ovarian cancer and a recently submitted European application for the same indication.
Corcept opened at $39.00 on Wednesday, traded between $32.99 and $39.00, and finished at $34.80. Volume was about 20.16 million shares.
Truist analyst Joon Lee said the FDA’s request for additional data could mean more trials and a longer road to approval. Reuters also noted competing approved treatments for Cushing’s syndrome include Recordati’s Isturisa and Xeris Biopharma’s Recorlev.
Wolfe Research downgraded Corcept to Underperform from Peer Perform and set a $30 price target after the FDA letter, saying another trial was likely and removing projected relacorilant sales for Cushing’s from its model, The Fly reported.
In plain terms, a complete response letter pauses the approval process: the agency is telling a company it needs more work before it can market the drug for that specific use. What comes next often boils down to whether the FDA is asking for a new clinical study, a new analysis of existing data, or both.
Investors will be watching for any detail on the scope of the FDA’s requested evidence and how quickly Corcept can map out a new regulatory path. The size of any additional trial and the expected timing for a resubmission will be key inputs for 2026 spending plans and updated expectations.
U.S. equity markets are closed on Thursday for New Year’s Day and reopen on Friday, January 2.
Before the next session, traders will also look ahead to the next results update as a forum for management to quantify the financial impact. Zacks’ earnings calendar lists February 25, 2026 as the next scheduled earnings date.
