FDA Rejects Corcept's Relacorilant Application; Securities Lawsuits Follow

On December 31, 2025, Corcept Therapeutics announced it received a Complete Response Letter from the FDA, denying approval of the company's new drug application for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism. The FDA acknowledged the results of the previous GRACE and GRADIENT drug trials, but concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness.

In direct response to this news, Corcept's stock price fell by $31.42 (44.76%) per share to open at $38.78 per share on December 31, 2025. This drop marked a new 52-week low for Corcept's stock, dropping to levels not seen since September 2024.

Following the FDA decision, the company faced mounting legal and regulatory pressure, with multiple securities class actions filed after the Complete Response Letter was issued. The securities class actions allege potential violations of the federal securities laws.

In February 2026, Corcept Therapeutics reported that full-year 2025 net income fell to US$99.65 million from US$141.21 million a year earlier, while guiding 2026 net revenue to a range of US$900 million to US$1,000 million. This guidance was issued shortly after disclosing the FDA's Complete Response Letter and the related class actions, and suggests management still sees material demand for its existing Cushing's business while it works through regulatory questions on relacorilant and ongoing litigation.

The FDA's Complete Response Letter on relacorilant in Cushing's syndrome directly affects regulatory setbacks slowing diversification while Korlym faces pricing and legal pressure. The company's cortisol-modulation platform had been expected to broaden beyond Korlym, with relacorilant anticipated to become a meaningful second pillar in both endocrinology and oncology.