Company: CORT
Filing Date: 2025-11-04
Form Type: 10-Q
Source: 0001628280-25-048841
Chunk: 168

Company: CORCEPT THERAPEUTICS INC
Filing Date: 2025-11-04
Form: 10-Q
Item: Part I, Item 3
Chunk 168
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 imposed new trade tariffs, increased existing tariffs, and abruptly paused or reversed tariff policies in ways that will increase our costs and make planning difficult. The government’s actions have caused economic and regulatory uncertainty and have been adverse to our clinical and commercial efforts. 

It is likely the administration will adopt new policies or take new actions that make it more difficult and costly to develop our product candidates. Significant cuts or disruptions to the staffing of government agencies and their budgets may delay review of our NDAs for relacorilant as a treatment for patients with hypercortisolism and platinum-resistant ovarian cancer and may hamper our ability to advance our other clinical programs, including the development of dazucorilant for the treatment of patients with ALS. The research programs of our academic collaborators may be canceled or their funding reduced. All of these actions may be taken with little or no advance notice.

The significant cuts to funding for Medicaid contained in the OBBBA enacted in July 2025 will increase the cost of our financial assistance and charitable donation programs. There may be further reductions in federal healthcare spending that harm our business.

The imposition of tariffs on materials we or our vendors and collaborators use to conduct experiments or to make our Products or product candidates have increased our costs and may increase them further. The United States’ tariff regime and the tariff regime of its trading partners are in constant flux. Although we monitor the situation closely, the tariffs that may affect our business are difficult to predict. It is unlikely that we will be able to anticipate new trade measures or mitigate their impacts, which could be material. Additionally, the laws and regulations governing our operations, as well as the application of those laws and regulations, may change without notice. Failure by us or our vendors to comply with new laws or regulations or to respond in a timely way to abrupt changes in the application of existing laws and regulations could adversely affect our operations, cash flow and financial condition or otherwise harm our business.

Additionally, disruptions at the FDA may impede its ability to review applications to start clinical trials, complete reviews of new drug applications, and conduct other activities critical to our business in a timely way or at all. On October 1, 2025, the Congress and the President failed to pass legislation required to fund government activities and, as a consequence, the government has ceased to perform many of its normal functions. Regulatory agencies, including the FDA, have had to furlough some critical employees and stop some critical activities. Although some of the activities upon which our business relies, including the review