The FDA released a complete response letter and asserted it had raised serious concerns with Corcept Therapeutics prior to the company’s submission for a Cushing’s syndrome therapy, contradicting Corcept’s claims that the rejection was unexpected. Agency statements indicate earlier communications signaled ‘significant review issues’ that would require additional data. Corcept maintains it followed guidance but acknowledged the FDA’s decision; the public exchange highlights growing scrutiny around approval readiness for complex endocrine agents. The episode underscores the importance of pre‑submission alignment with regulators and the reputational and commercial consequences of a high‑profile regulatory setback.