CORT 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-11-03

• In 2025, we conducted the MOMENTUM trial to determine the prevalence of hypercortisolism in patients with resistant hypertension. Resistant hypertension is defined by the American Heart Association as systolic blood pressure greater than 130 mm Hg and diastolic blood pressure greater than 80 mm Hg, …

• On December 30, 2025, the FDA issued a Complete Response Letter (“CRL”) declining to approve relacorilant. While the letter acknowledged that the pivotal GRACE trial met its primary endpoint and that the GRADIENT trial had provided confirmatory evidence, the FDA stated that additional evidence of ef…

• hyperglycemia met the study’s response criteria. Patients with hyperglycemia who entered the randomized withdrawal phase exhibited more pronounced improvements, with reductions in AUCglucose of 6.2 h*mmol/L, HbA1c of 0.7 percent and fasting glucose of 25.2 mg/dL at 22 weeks (p-values: <0.0001, <0.00…

• Cortisol activity at the GR reduces the efficacy of certain anti-cancer therapies and there is substantial evidence that antagonizing cortisol at a solid tumor’s glucocorticoid receptors may help those therapies achieve their intended effect. Cortisol suppresses the body’s immune response; activatin…

• cancers. In some cancers, cortisol retards cellular apoptosis – the tumor-killing effect many treatments are meant to stimulate. In other cancers, cortisol activity promotes tumor growth. Many types of solid tumors are potential targets for cortisol modulation therapy, among them ovarian, endometria…

相对上期删除的文字 · 来源:10-Q · 2026-07-29

• To determine the prevalence of hypercortisolism in patients with resistant hypertension, we conducted the MOMENTUM trial in 2025. Resistant hypertension is defined by the American Heart Association as systolic blood pressure greater than 130 mm Hg and diastolic blood pressure greater than 80 mm Hg, …

• medications of different classes, including a diuretic. Of the 1,086 patients enrolled in MOMENTUM, 27.3 percent were found to have hypercortisolism. MOMENTUM’s results were presented at the American College of Cardiology Annual Scientific Session in March 2026.

• On December 30, 2025, the FDA issued a Complete Response Letter (“CRL”) declining to approve relacorilant. While the letter acknowledged that our pivotal GRACE trial had met its primary endpoint and that our GRADIENT trial had provided confirmatory evidence, the FDA stated that additional evidence o…

• Cortisol activity at the GR reduces the efficacy of certain anti-cancer therapies and there is substantial evidence that antagonizing cortisol at a solid tumor’s glucocorticoid receptors may help those therapies achieve their intended effect. In some cancers, cortisol retards cellular apoptosis – th…

• Relacorilant in Combination with Chemotherapy. In March 2026, the FDA approved Lifyorli (relacorilant) in combination with the chemotherapy medication nab-paclitaxel to treat patients with platinum-resistant ovarian cancer who have received one to three prior systemic treatment regimens, at least on…

相对上期新增的文字 · 来源:10-Q · 2026-11-03

• On February 20, 2026, a putative securities class action complaint was filed in the United States District Court for the Northern District of California against Corcept and certain of its executive officers, now captioned In re Corcept Therapeutics Incorporated Securities Litigation, Case No. 3:26-c…

• We will continue to vigorously enforce our intellectual property rights relating to Korlym. We intend to petition the United States Supreme Court for a writ of certiorari to overturn the Federal Circuit Court’s decision.

• to remand this case back to the state court. On July 20, 2026, the Alameda County Superior Court for the State of California denied our motion to stay this proceeding pending resolution of the Teva Antitrust Litigation. The state court also granted in part and denied in part our motion to dismiss th…

相对上期删除的文字 · 来源:10-Q · 2026-07-29

• On February 20, 2026, a purported securities class action complaint was filed in the United States District Court for the Northern District of California by the Allegheny County Employees’ Retirement System (Allegheny County Employees’ Retirement System v. Corcept Therapeutics Incorporated, et al., …

• We will continue to vigorously enforce our intellectual property rights relating to Korlym.

• denied our motion to stay this proceeding pending resolution of the Teva Antitrust Litigation. The Court also granted in part and denied in part our motion to dismiss the plaintiffs’ complaint. A trial date has not been set for the Aetna Litigation.

相对上期新增的文字 · 来源:10-Q · 2026-11-03

• •Other companies offer medications that treat patients with hypercortisolism (including generic versions of Korlym) and patients with platinum-resistant ovarian cancer. The availability of such competing treatments could limit our product revenue.

• •Our efforts to discover, develop and commercialize our product candidates may not succeed. Clinical drug development is lengthy, expensive and often unsuccessful. Results of early studies and trials are often not predictive of later trial results. Failure can occur at any time. Even if we deem that…

• •the inability of our pharmacy and distributor vendors to dispense our Products in a timely manner;

• •lack of availability of government or private insurance, the shift of a significant number of patients to Medicaid, which reimburses our Products at a significantly lower price, or the introduction of government price controls or other price-

• reducing regulations, such as the IRA, that may significantly limit Medicare reimbursement rates and the One Big Beautiful Bill Act (“OBBBA”) of 2025, which will reduce Medicaid funding significantly.

相对上期删除的文字 · 来源:10-Q · 2026-07-29

• •The availability and adoption of generic versions of Korlym, other than our authorized generic of Korlym, could adversely affect our business, results of operations and financial position.

• •Our efforts to discover, develop and commercialize our product candidates may not succeed. Clinical drug development is lengthy, expensive and often unsuccessful. Results of early studies and trials are often not predictive of later trial results. Failure can occur at any time. Even if we deem that…

• •lack of availability of government or private insurance, the shift of a significant number of patients to Medicaid, which reimburses our Products at a significantly lower price, or the introduction of government price controls or other price-reducing regulations, such as the Inflation Reduction Act…

• •the inability of our pharmacy and distributor vendors to dispense our Products in a timely manner.

• The availability and adoption of generic versions of Korlym, other than our authorized generic of Korlym, could adversely affect our business, results of operations and financial position.

相对上期新增的文字 · 来源:10-Q · 2026-11-03

• Roberto Vieira, our President, Oncology, was appointed as an officer, as defined in Rule 16a-1(f) under the Exchange Act, effective as of September 1, 2026. Mr. Vieira adopted a Rule 10b5-1 trading arrangement on June 17, 2026, prior to his appointment as an officer. As Mr. Vieira was not an officer…

相对上期删除的文字 · 来源:10-Q · 2026-07-29

• Joseph D. LyonChief Accounting & Technology OfficerAdoption6/10/2026

• Joseph K. Belanoff, M.D.Chief Executive Officer and DirectorAdoption6/11/2026