NEW YORK, January 2, 2026, 2:30 PM ET — Regular session
- Corcept Therapeutics shares rose about 6% in afternoon trading, recouping part of Wednesday’s steep drop.
- The FDA issued a complete response letter for relacorilant in Cushing’s-related hypertension, saying more evidence is needed.
- Focus is shifting to the company’s next regulatory milestones, including a July FDA decision date in ovarian cancer.
Corcept Therapeutics Incorporated shares were up 5.7% at $36.77 on Friday afternoon, after a sharp selloff earlier in the week tied to a U.S. regulatory setback for its experimental drug relacorilant.
The bounce matters because the FDA’s decision hit what investors had seen as a key growth driver beyond Corcept’s marketed therapy, and it reset expectations for how quickly relacorilant can reach patients in the company’s lead endocrine indication.
A complete response letter is the FDA’s notice that a drug application cannot be approved as filed. For investors, it often means delays, higher development costs and more uncertainty around revenue timing.
Corcept said the FDA issued a complete response letter for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism, a condition linked to excess cortisol. “We are surprised and disappointed by this outcome,” Chief Executive Officer Joseph K. Belanoff said in a statement, adding the company planned to meet with the agency “as soon as possible” to discuss next steps. 1
In the same release, Corcept said relacorilant is being developed across multiple indications, and noted the FDA has set a July 11, 2026 PDUFA date — the agency’s target decision deadline — for relacorilant in platinum-resistant ovarian cancer, while the company has also submitted a marketing application to Europe’s medicines regulator. 2
The FDA said it could not reach a favorable benefit-risk assessment for relacorilant in the requested use without additional evidence of effectiveness, Reuters reported. Truist analyst Joon Lee wrote that the request “may require additional trials,” a path that would weigh on the drug’s timeline in Cushing’s. 3
BioSpace reported Corcept pursued approval despite relacorilant performing no better than placebo in one of two Phase III trials, and said Truist cut its price target after the decision while arguing the setback “has no bearing” on the ongoing FDA review in ovarian cancer. 4
Friday’s move also stood out against a softer biotech tape: the SPDR S&P Biotech ETF was down about 0.8% and the iShares Nasdaq Biotechnology ETF was off roughly 0.3%, while the SPDR S&P 500 ETF traded little changed.
Corcept’s reversal leaves the stock well below levels seen before the FDA letter. The company is now trading on the durability of its existing business and on whether it can chart a clear, fundable regulatory path for relacorilant in hypercortisolism.
Traders are watching for any details from Corcept’s planned FDA meeting — including whether the agency is signaling a narrower data request, or the need for a new study — and whether management offers timelines that can be modeled.
Beyond company-specific headlines, investors are also eyeing early-January macro catalysts that can move risk appetite broadly, including U.S. jobs data in the coming days, after a quiet holiday stretch. 5
