Corcept's FDA CRL: A Catalyst for a New Valuation or a Dead End?

The catalyst is now in the record. On December 31, 2025, the FDA delivered a Complete Response Letter (CRL) rejecting Corcept's application for relacorilant as a treatment for hypertension secondary to hypercortisolism, a rare condition often called Cushing's syndrome. The immediate market impact was brutal. Shares plunged roughly 50% to a new 52-week low near $36, triggering a trading halt and a surge in put buying as investors scrambled to hedge their positions.

The core regulatory hurdle is clear. While the FDA acknowledged that Corcept's pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial provided confirmatory evidence, the agency concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without the company providing additional evidence of effectiveness. In other words, the data wasn't deemed sufficient to prove the drug's benefits outweigh its risks for this specific indication.

CEO Joseph K. Belanoff's reaction was one of surprise and disappointment. "We are surprised and disappointed by this outcome," he stated, adding that he is "confident we will find a way to get relacorilant to the patients it could help" and that the company would meet with the FDA as soon as possible to discuss the path forward. This CRL, issued on the final business day of the year, has fundamentally reset the near-term valuation story for Corcept.

The Data Dilemma: Mixed Trial Results and Commercial Reality

The FDA's rejection hinges on a data set that is deeply conflicted. Corcept's own trials tell a split story. One Phase III study, the GRACE trial, met its primary endpoint for lowering blood pressure in Cushing's patients. The other, the GRADIENT trial, failed to show statistical significance versus placebo. The agency acknowledged the positive GRACE result but concluded the overall evidence was insufficient to prove the drug's benefits outweigh its risks. In other words, the FDA saw a promising signal but not a clear enough picture to approve the drug.

This creates an immediate financial vacuum. Truist Securities has removed relacorilant from its financial model for Cushing's syndrome, leaving only the sales of Korlym, the company's existing Cushing's drug. Korlym is already under pressure from Teva's generic version, which will likely erode its pricing power and market share. The removal of relacorilant from the model strips away a major growth catalyst and significantly dims Corcept's near-term revenue outlook for its core business.

The regulatory setback is now compounded by legal and reputational risk. The sharp 50% stock drop has prompted a shareholder rights investigation into whether Corcept misled investors about relacorilant's prospects. The firm Hagens Berman points to past statements where management expressed "confidence" in approval by year-end and projected a hypercortisolism business growing to $3-5 billion. The CRL directly contradicts those assurances, opening the door to potential investor misconduct claims. This adds a layer of uncertainty that extends far beyond the regulatory hurdle, creating a potential drag on the stock as the company navigates both a clinical and a legal challenge.

Valuation and Path Forward: Scenarios and Catalysts

The immediate valuation impact is stark. Analyst price targets have been slashed, reflecting a severe discount to pre-CRL levels. Wolfe Research now sees a $30 price target, while Truist Securities cut its view to $50 from $135. These new benchmarks, set against a stock trading near $36, signal deep skepticism about the near-term path. The consensus is now a "Hold," a clear retreat from the "Buy" ratings that dominated just weeks ago.

This sets up a stark strategic choice for Corcept. The company must decide between a costly, high-risk resubmission or walking away from the indication. The FDA's demand for additional evidence of effectiveness is the core hurdle. Analysts at Truist note this "may require additional trial(s)," a path that would be both expensive and time-consuming. Yet CEO Joseph Belanoff has stated he is "confident we will find a way to get relacorilant to the patients it could help." The company's next move-whether it commits to new trials or pivots-will be the single most important catalyst for the stock's direction in the coming months.

A key near-term event is the company's response to the CRL. Management's planned meeting with the FDA will be scrutinized for any hint of a path forward that avoids new trials. Any announcement of a resubmission strategy, even with a timeline, could provide a temporary floor for the stock. Conversely, a lack of a clear plan would likely confirm the worst-case scenario of a dead-end indication.

There is a potential positive catalyst on the horizon unrelated to the Cushing's rejection. The FDA is scheduled to rule on relacorilant's application for ovarian cancer in the coming months. Analysts note this review is separate and unaffected by the Cushing's decision. A successful approval for this second indication would provide a critical validation of the drug's utility and a new revenue stream, offering a potential offset to the disappointment in the primary indication.

The bottom line is one of high uncertainty. The stock's valuation has been reset, but the path forward is not yet defined. Investors must watch for the company's response to the CRL and any updates on the ovarian cancer PDUFA date, as these will determine whether the recent plunge represents a buying opportunity or the start of a longer decline.