Company: CORT
Filing Date: 2025-11-04
Form Type: 10-Q
Source: 0001628280-25-048841
Chunk: 131

Company: CORCEPT THERAPEUTICS INC
Filing Date: 2025-11-04
Form: 10-Q
Item: Part I, Item 2
Chunk 131
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 us from commercializing our product candidates.

We cannot sell a product without the approval of the FDA, EMA or comparable regulatory authority. Obtaining such approval is difficult, uncertain, lengthy and expensive. Failure can occur at any stage. In order to receive FDA approval for a new drug, we must demonstrate to the FDA’s satisfaction that the new drug is safe and effective for its intended use and that our manufacturing processes comply with cGMPs. Recent disruptions at the FDA and other government agencies caused by changing presidential administrations or funding shortages could hinder their ability to hire, retain or deploy key leadership and other personnel, prevent new or modified product candidates from being developed, reviewed, approved or commercialized in a timely manner or at all, which could negatively impact our business. Our inability or the inability of our vendors to comply with applicable FDA and other regulatory requirements can result in delays in or denials of new product approvals, warning letters, untitled letters, fines, consent decrees restricting or suspending manufacturing operations, injunctions, civil penalties, recall or seizure of products, total or partial suspension of product sales and criminal prosecution. We may seek to commercialize our Products in international markets, which would require us to receive a marketing authorization and, in many cases, pricing approval, from the appropriate regulatory authorities. Approval procedures vary between countries and can require additional 

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pre-clinical or clinical studies. Obtaining approval may take longer than it does in the United States. Although approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does not ensure approval by others, failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. Any of these or other regulatory actions could materially harm our business and financial condition.

We have submitted one NDA for relacorilant as a treatment for patients with hypercortisolism and another as a treatment, in combination with the chemotherapy medication nab-paclitaxel, for patients with platinum-resistant ovarian cancer. Both NDAs are under review by the FDA with PDUFA dates of December 30, 2025 and July 11, 2026, respectively. We have also submitted to the EMA an MAA for relacorilant as a treatment for patients with platinum-resistant ovarian cancer with a likely regulatory decision date in the fourth quarter of 2026. These applications may be delayed and there is no assurance that they will be approved.

If we receive regulatory approval for a