Corcept Therapeutics Faces Legal Scrutiny Following FDA Rejection

Corcept Therapeutics US2183521028

Corcept Therapeutics is navigating significant regulatory and legal challenges after the U.S. Food and Drug Administration (FDA) declined to approve its key drug candidate, Relacorilant, for a specific condition. This decision has triggered a decline in the company's share price and prompted law firms to initiate investigations into potential securities law violations on behalf of shareholders.

Specialized law firms launched investigations in early February to examine whether Corcept Therapeutics violated U.S. securities regulations. The core issue under review is whether company officials failed to disclose negative feedback from the FDA, thereby potentially misleading investors about Relacorilant's true prospects. This legal scrutiny follows a noticeable drop in the company's stock value in reaction to the regulatory setback.

FDA Rejection and Prior Warnings

The FDA refused to grant approval for Relacorilant as a treatment for hypertension due to hypercortisolism around the turn of the year. Although clinical trials GRACE and GRADIENT yielded positive data, the agency concluded it could not establish a favorable benefit-risk profile for the drug. The path to market for this indication is now blocked unless Corcept can provide additional evidence of efficacy.

A particularly critical development emerged in a late-January update concerning the FDA's complete response letter. This disclosure revealed that the regulator had issued multiple warnings to the company prior to the application submission. The FDA had expressed early concerns about the clinical development program and highlighted anticipated deficiencies in the review process. This revelation raises questions about management's transparency with investors during this period.

Upcoming Catalysts and Financial Calendar

Despite this setback for the hypercortisolism indication, Corcept continues to develop Relacorilant for other uses. A major regulatory milestone is scheduled for July 11, when the FDA will decide on approving the drug for the treatment of platinum-resistant ovarian cancer.

The company's financial reporting will soon take center stage. Corcept is expected to release its fourth-quarter 2025 results on Wednesday, February 25. Prior to that, a conference call is anticipated on February 18, during which management will likely address the regulatory pathway and the status of the ongoing legal investigations.