Corcept Therapeutics Faces Legal Scrutiny Over Drug Application

Corcept Therapeutics US2183521028

Biopharmaceutical firm Corcept Therapeutics is the subject of multiple legal investigations in the United States. Several prominent law firms are examining whether the company misled its shareholders regarding the regulatory prospects for its drug, Relacorilant. The inquiries focus on Corcept's communications with the U.S. Food and Drug Administration (FDA), which appear to have been more contentious than previously disclosed to investors.

The core allegation centers on the company's application for Relacorilant as a treatment for hypercortisolism, which the FDA formally rejected on December 31 of last year. While clinical trials named GRACE and GRADIENT provided evidence of efficacy, the regulatory body requested additional data for a final benefit-risk assessment. This news triggered a significant decline in the company's share price, which ended the trading session at $34.80.

Investigations led by firms including Hagens Berman and Pomerantz are probing several key areas. These include potential breaches of U.S. securities laws, the possibility of misleading statements to shareholders, and the alleged omission of material information concerning the drug approval process. A critical piece of evidence is a corrected FDA correspondence dated January 28. Reports indicate the agency had warned the company on several prior occasions against submitting the application in its existing form. A central question for investigators is whether management downplayed these known risks to artificially support the stock's valuation.

Oncology Division Offers a Counterbalance

Amid these regulatory challenges in one therapeutic area, Corcept has reported positive developments in another. At the end of January, the company's Phase 3 ROSELLA trial for treating platinum-resistant ovarian cancer successfully met its primary endpoint. Data showed that a combination therapy of Relacorilant and Nab-Paclitaxel reduced the risk of death by 35% compared to monotherapy.

This clinical success prompted a partial recovery in the stock's value. The FDA has accepted the related new drug application for this oncology indication, with a decision expected by the PDUFA date of July 11, 2026. While this future date represents a potential strategic pivot for the company, the ongoing legal fallout from the earlier FDA communications regarding hypercortisolism is likely to dominate investor attention in the near term.

@ boerse-global.de | US2183521028 CORCEPT