FDA's CRL Decision Triggers Sharp Decline in Corcept Stock Following Relacorilant Setback

Corcept Therapeutics (CORT) experienced a significant market correction when the FDA issued a complete response letter regarding its relacorilant application for hypercortisolism treatment. The stock declined 50.4% on December 31 following this regulatory development. Over the preceding six months, CORT shares have fallen 51.8%, substantially underperforming the biotech industry’s 3.4% gain.

Understanding the FDA’s CRL Response to Relacorilant

The company’s submission for relacorilant—a selective cortisol modulator designed to treat hypercortisolism (Cushing’s syndrome)—faced regulatory hurdles when the FDA issued its CRL in December 2024. While the GRACE study demonstrated positive primary endpoint results and the GRADIENT phase III study corroborated those findings, the FDA determined that additional effectiveness data was necessary before approving the drug. The regulatory agency requested more evidence to substantiate that relacorilant’s clinical benefits justify the safety considerations involved in its use for hypercortisolism patients, particularly those with secondary hypertension complications.

This CRL essentially requires Corcept to conduct additional studies before resubmission can occur. Such requirements typically extend development timelines significantly, which explains the pronounced investor reaction on announcement date.

Relacorilant’s Pipeline Beyond Hypercortisolism

Despite the setback in Cushing’s syndrome indication, relacorilant continues advancing in oncology applications. The FDA accepted an NDA in September 2025 for relacorilant combined with nab-paclitaxel for platinum-resistant ovarian cancer, with a regulatory decision anticipated by July 11, 2026.

Corcept simultaneously pursued European regulatory approval, submitting a marketing authorization application to the EMA for the same ovarian cancer indication, expecting a European decision by end of 2026. The company is also investigating a combination approach in its phase II BELLA study, which evaluates relacorilant alongside nab-paclitaxel and Avastin for platinum-resistant ovarian cancer patients, potentially establishing whether triple-combination therapy provides additional therapeutic value.

Market Implications and Revenue Dependencies

The hypercortisolism CRL represents a meaningful setback because successful approval would have enabled Corcept to expand beyond its current single revenue driver. Korlym, the company’s sole marketed product for treating Cushing’s syndrome, generated $559.3 million in sales during the first nine months of 2025, reflecting 13.4% year-over-year growth. Relacorilant approval would have diversified the revenue base and reduced dependency on this single medication.

The FDA’s CRL decision now raises questions about whether this regulatory stance will influence upcoming oncology decisions, potentially creating uncertainty around Corcept’s broader pipeline prospects.

Investment Perspective

Corcept currently maintains a Zacks Rank #3 (Hold) rating. Investors monitoring the biotech sector may consider evaluating peers with stronger near-term catalysts in the research pipeline before making allocation decisions.