The FDA released a complete response letter for Corcept Therapeutics’ Cushing’s syndrome candidate and stated the agency had voiced serious concerns prior to the application submission. Corcept’s lead asset for an endocrine disorder faced a regulatory rejection that the company had characterized as unexpected. The agency’s letter details pre‑submission interactions where it identified issues that, in FDA view, would pose significant review challenges. Corcept’s public statements and the FDA’s disclosure highlight disagreements over the timing and sufficiency of data submitted in support of efficacy and safety claims. For small pharma, the episode underscores the importance of early, clear regulatory alignment on pivotal datasets and risk tolerability; it also illustrates how pre‑submission communications can form the basis for later review outcomes and regulatory decisions.