Corcept Stock Rebounds Sharply After FDA Setback for Relacorilant
Investors look past the regulator's rejection for a hypertension indication, focusing on the drug's larger potential in ovarian cancer.
Shares of Corcept Therapeutics (NASDAQ: CORT) experienced a volatile trading session, initially falling on news of a regulatory setback before mounting a significant comeback as investors recalibrated their focus on the company’s more promising oncology pipeline.
The initial downturn was triggered after the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of its lead candidate, relacorilant. The application sought approval for the treatment of hypertension secondary to hypercortisolism, a specific condition associated with high cortisol levels. The stock plunged in pre-market trading before rebounding to close up nearly 10% in the following session.
A CRL from the FDA indicates that the agency will not approve the application in its present form. In its official communication on December 31, 2025, Corcept stated that the regulator is requesting additional evidence of effectiveness to support a favorable benefit-risk assessment for this specific patient population. The company has announced its intention to meet with the FDA to discuss the letter and determine the next steps for the program.
While any regulatory rejection is a blow, the market's subsequent reversal suggests investors quickly recognized the limited scope of the decision. Crucially, the CRL does not impact the ongoing development of relacorilant for a different, and potentially more lucrative, indication: the treatment of platinum-resistant ovarian cancer. Corcept confirmed that this separate program remains on track, with a Prescription Drug User Fee Act (PDUFA) date set for July 11, 2026, for a final FDA decision.
The market's quick pivot reflects the strategic importance of the oncology application for Corcept's future growth. Relacorilant is a selective glucocorticoid receptor antagonist, and its mechanism of action is being studied for its potential to enhance the efficacy of chemotherapy in solid-tumor cancers.
"The initial, knee-jerk sell-off was likely an overreaction from investors who didn't immediately distinguish between the two separate indications for relacorilant," noted one analyst. "The smart money quickly realized the main thesis—the oncology application—remains fully intact."
This sentiment was evident in the trading data. After the pre-market drop, CORT shares surged during the main session on higher-than-average volume. The stock currently trades around $36.75, well below its 52-week high of $117.33, but the rebound indicates a resilient investor base. Wall Street's consensus remains optimistic, with an average analyst price target of $91.00, suggesting significant upside if the company's oncology program succeeds.
Corcept, which generated over $740 million in revenue in the last twelve months primarily from its existing Cushing's syndrome drug Korlym, is viewed by many as having a solid financial foundation to weather the current setback. The market is now keenly focused on the summer PDUFA date for the ovarian cancer indication, which will be a far more significant catalyst for the biopharmaceutical company's long-term valuation.