Corcept Therapeutics, a California-based biotech company, encountered a major setback when the FDA rejected its drug relacorilant, which was designed to treat hypertension secondary to hypercortisolism, commonly known as Cushing's syndrome. Although the drug achieved its primary endpoint in clinical trials, the FDA determined that insufficient evidence of effectiveness existed. This regulatory rejection caused the company's stock price to plummet 50%.

The FDA's response indicated that additional clinical evidence would be necessary for approval. Corcept intends to consult with FDA officials regarding potential pathways forward, though the approval process now appears considerably more challenging.

The company may need to conduct extensive additional research and clinical testing to address the FDA's concerns about the drug's effectiveness.