CORT 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-07-29

• Our Hypercortisolism Products. We sell Korlym and our authorized generic version of Korlym in the United States (our “Hypercortisolism Products”) using sales representatives to call on physicians caring for patients with hypercortisolism. We also have a field-based force of medical science liaisons.…

• 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.

• Our Phase 3 GRADIENT study enrolled patients with hypercortisolism caused by adrenal adenomas or adrenal hyperplasia. These patients have a more gradual decline than patients with other etiologies of hypercortisolism, although their health outcomes are ultimately poor. GRADIENT enrolled 137 patients…

• Patients in GRADIENT who received relacorilant exhibited clinically meaningful improvements in a wide array of hypercortisolism signs and symptoms, including hypertension, hyperglycemia, weight and body composition, while patients who received placebo did not.

• GRADIENT patients with hypertension who received relacorilant experienced a reduction in SBP of 6.6 mm Hg (p-value: 0.012) compared to baseline. The reduction in patients who received placebo was 2.1 mm Hg (p-value: ns) compared to baseline. The comparison between those who received relacorilant and…

相对上期删除的文字 · 来源:10-Q · 2026-04-30

• Our Hypercortisolism Products. We sell Korlym and a generic version of Korlym in the United States (our “Hypercortisolism Products”) using sales representatives to call on physicians caring for patients with hypercortisolism. We also have a field-based force of medical science liaisons. From 2017 to…

• in hyperglycemia, waist circumference, fat and lean tissue mass, while patients who received placebo experienced a significant worsening of hypercortisolism signs and symptoms.

• Our Phase 3 GRADIENT study enrolled patients with hypercortisolism caused by adrenal adenomas or adrenal hyperplasia. These patients have a more gradual decline than patients with other etiologies of hypercortisolism, although their health outcomes are ultimately poor. GRADIENT enrolled 137 patients…

• Patients in GRADIENT who received relacorilant exhibited clinically meaningful improvements in a wide array of hypercortisolism’s signs and symptoms, including hypertension, hyperglycemia, weight and body composition, while patients who received placebo did not.

• GRADIENT patients with hypertension who received relacorilant experienced a reduction in systolic blood pressure of 6.6 mm Hg (p-value 0.012) compared to baseline. The reduction in patients who received placebo was 2.1 mm Hg (p-value: ns) compared to baseline. The comparison between those who receiv…

相对上期新增的文字 · 来源:10-Q · 2026-07-29

• 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.

• We will continue to vigorously defend ourselves against these lawsuits.

• In 2017, a qui tam lawsuit was filed under seal in the U.S. District Court for the District of New Jersey (U.S. et al. ex rel. Stephen Elliott v. Corcept Therapeutics, Inc., No. 17-CV-1303 (SRC)) by a former employee who worked at Corcept until August 2016 (the “Qui Tam Action”). A qui tam action is…

• On April 10, 2026, a purported shareholder derivative complaint was filed in the U.S. District Court for the Northern District of California by Mark LeRiger, captioned LeRiger v. Belanoff et al., Case No. 3:26-cv-03106 (N.D. Cal.). This complaint names as defendants several of our executive officers…

• In addition to the above-described matters, we are involved from time to time in other legal proceedings arising in the ordinary course of our business. Although the outcome of any such matters and the amount, if any, of our liability with respect to them cannot be predicted with certainty, we do no…

相对上期删除的文字 · 来源:10-Q · 2026-04-30

• On April 10, 2026, a purported shareholder derivative complaint was filed in the U.S. District Court for the Northern District of California by Mark LeRiger, captioned LeRiger v. Belanoff et al., Case No. 3:26-cv-03106 (N.D. Cal.). This complaint names as defendants several of our executive officers…

• In November 2021, we received a records subpoena from the United States Attorney’s Office for the District of New Jersey (the “NJ USAO”) pursuant to Section 248 of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) seeking certain information relating to Korlym. The NJ USAO ha…

• In addition to the above-described matters, we are involved from time-to-time in other legal proceedings arising in the ordinary course of our business. Although the outcome of any such matters and the amount, if any, of our liability with respect to them cannot be predicted with certainty, we do no…

相对上期新增的文字 · 来源:10-Q · 2026-07-29

• We also have litigation settlements with Sun Pharmaceutical Industries Limited (“Sun”) and Hikma Pharmaceuticals USA Inc. (“Hikma”) that allow them to begin selling mifepristone, with customary restrictions, provided the FDA has approved their products and Teva’s generic product remains commercially…

• In the United States, there have been and continue to be legislative initiatives to contain healthcare costs. The IRA significantly changed the way Medicare pays for prescription drugs. The IRA requires the Secretary of the U.S. Department of Health and Human Services to negotiate Medicare prices fo…

• Congress could also introduce and ultimately pass additional health care legislation changing the Medicare Drug Price Negotiation Program created under the IRA, which may lower the price that we receive for our Products. Any denial in coverage or reduction in reimbursement from Medicare or other gov…

• Any expansion, finalization or implementation of these or similar most favored nation (“MFN”) or MFN-based pricing initiatives could subject our Products to additional rebate obligations, negatively impact our pricing strategies, product demand, or competitive positioning across global markets, and …

• Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models could impact our future product revenues and materially harm our business.

相对上期删除的文字 · 来源:10-Q · 2026-04-30

• •the preference of physicians or payors for competing treatments for platinum-resistant ovarian cancer;

• District Court’s ruling. If Teva’s commercial efforts are successful, they may materially harm our results of operations and financial condition by reducing the number of tablets we sell or lowering their price or both.

• We also have litigation settlements with Sun Pharmaceutical Industries Limited (“Sun”) and Hikma Pharmaceuticals USA Inc. (“Hikma”) that allow them to begin selling mifepristone, with customary restrictions, provided the FDA has approved their products and Teva’s generic product remains commercially…

• In the United States, there have been and continue to be legislative initiatives to contain healthcare costs. The IRA significantly changed the way Medicare pays for prescription drugs. The IRA requires the Secretary of the U.S. Department of Health and Human Services to negotiate Medicare prices fo…

• annual Medicare expenditures are exempt from the negotiation program. For the first two years of the program, 2026 and 2027, only Part D drugs are eligible. The Secretary will publish the negotiated price, known as the “Maximum Fair Price” (“MFP”), for each of the selected products. Manufacturers of…

相对上期新增的文字 · 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