Company: CORT
Filing Date: 2025-11-04
Form Type: 10-Q
Source: 0001628280-25-048841
Chunk: 130

Company: CORCEPT THERAPEUTICS INC
Filing Date: 2025-11-04
Form: 10-Q
Item: Part I, Item 2
Chunk 130
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 regulatory approval. The results from early clinical trials are often not predictive of results in later clinical trials. Product candidates may fail to show the desired safety and efficacy traits despite having produced positive results in preclinical studies and initial clinical trials. Many companies have suffered significant setbacks in late-stage clinical trials due to lack of efficacy or unanticipated or unexpectedly severe adverse events.

Our current clinical trials may prove inadequate to support marketing approvals. Even trials that generate positive results may have to be confirmed in much larger, more expensive and lengthier trials before we could seek regulatory approval.

Clinical trials may take longer to complete, cost more than expected and fail for many reasons, including:

•failure to show efficacy or acceptable safety;

•slow patient enrollment or delayed activation of clinical trial sites;

•delays obtaining regulatory permission to start a trial, changes to the size or design of a trial or changes in regulatory requirements for a trial already underway;

•inability to secure acceptable terms with vendors and an appropriate number of clinical trial sites;

•delays or inability to obtain institutional review board (“IRB”) approval at prospective trial sites;

•failure of patients or investigators to comply with the clinical trial protocol;

•unforeseen safety issues; and

•negative findings of inspections of clinical sites or manufacturing operations by us, the FDA or other authorities.

A trial may also be suspended or terminated by us, the trial’s data safety monitoring board, the IRBs governing the sites where the trial is being conducted or the FDA for many reasons, including failure to comply with regulatory requirements or clinical protocols, negative findings in an inspection of our clinical trial operations or trial sites by the FDA or other authorities, unforeseen safety issues, failure to demonstrate a benefit or changes in government regulations.

At any time prior to the regulatory approval of a product candidate, we may decide, or the FDA or other regulatory authorities may require us, to conduct more pre-clinical or clinical studies, provide additional analysis of existing data or change the size or design of a trial already underway. Such additional or changed requirements, which regulators may impose in their sole discretion, may delay or prevent the completion of development, submission of an NDA or the completion of regulatory review, which would increase our costs and adversely impact future revenue. Even if we conduct the clinical trials and supportive studies that we consider appropriate and the results are positive, we may not receive regulatory approval. Following regulatory approval, there is no assurance of commercial success.

We may be unable to obtain or maintain regulatory approvals for our Products or product candidates, which would prevent