Kuehn Law investigates Corcept over relacorilant disclosures
Kuehn Law is investigating Corcept Therapeutics Incorporated for potential breaches of fiduciary duty related to the disclosure of risks surrounding its relacorilant drug. A federal lawsuit alleges the company failed to communicate FDA concerns regarding its clinical development program and the risk of NDA rejection. Corcept recently resubmitted the NDA with additional data, aiming for approval to treat Cushing's syndrome.

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Kuehn Law, PLLC is investigating whether certain officers and directors of Corcept Therapeutics Incorporated breached their fiduciary duties to shareholders regarding the disclosure of risks associated with relacorilant. The investigation follows a federal securities lawsuit alleging the company failed to disclose adverse facts concerning the potential FDA approval of the drug, a treatment for hypercortisolism, or Cushing's syndrome. The lawsuit claims that while Corcept touted the expected success of FDA approval, it did not reveal that the FDA had expressed concerns about the adequacy of its clinical development program and that the New Drug Application faced a material risk of rejection.
The firm is encouraging shareholders who purchased Corcept stock prior to October 31, 2024, to contact Justin Kuehn, Esq. Kuehn Law pays all case costs and does not charge its investor clients. Shareholders are advised to contact the firm immediately due to potential time limits to enforce rights.
Corcept Therapeutics Incorporated recently resubmitted its New Drug Application (NDA) for relacorilant to the U.S. Food and Drug Administration (FDA). The resubmission includes additional analyses of data from the original submission, as requested by the FDA, and is expected to receive a six-month review. The application is supported by data from the pivotal GRACE trial, the Phase III GRADIENT trial, and a long-term extension study.
Relacorilant is an oral therapy and selective glucocorticoid receptor antagonist. It has been designated an orphan drug by the FDA and the European Commission for the treatment of hypercortisolism. Under the brand name Lifyorli, relacorilant was approved in combination with nab-paclitaxel for adults with platinum-resistant ovarian cancer by the FDA in 2026.
Hypercortisolism is caused by excessive cortisol activity and can lead to hypertension, central obesity, and type 2 diabetes. If untreated, the condition can be fatal, with cardiovascular events being the most common cause of death.
How will the ongoing federal securities lawsuit and fiduciary investigation impact investor confidence and Corcept's stock volatility during the FDA review period?
What are the specific criteria the FDA will evaluate during the six-month review of the resubmitted NDA, and how might the additional data address previous concerns?
If relacorilant receives FDA approval for hypercortisolism, how will Corcept balance marketing efforts for this new indication alongside its existing oncology use under the brand name Lifyorli?
























