Why did the FDA issue a corrected letter to Corcept Therapeutics?

The FDA issued a corrected letter to Corcept Therapeutics to emphasize that it had repeatedly warned the company not to submit its drug application and that significant review issues were expected.

What were the main reasons for the FDA's rejection of Corcept's relacorilant drug?

The FDA rejected relacorilant because the main clinical trial failed to show it worked better than placebo and due to serious liver safety concerns, including probable drug-induced liver injury in four patients.

What are the next steps for Corcept Therapeutics regarding its rejected drug application?

Corcept has one year to resubmit its application and take other actions; otherwise, the FDA will consider the lack of response a request to withdraw the application.

Home / Business and Economy / Corcept Shares Plummet After FDA Rejection

Corcept Shares Plummet After FDA Rejection

31 Jan

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Summary

FDA issued a corrected letter, citing repeated warnings to Corcept.
Drug application rejected due to trial failure and liver safety issues.
Corcept faces potential withdrawal if no response to FDA.

Corcept Shares Plummet After FDA Rejection

Shares of Corcept Therapeutics experienced a significant decline of 16% on Friday following a corrected "complete response letter" from the U.S. Food and Drug Administration (FDA). This revised letter revealed that the FDA had previously cautioned the company on multiple occasions against submitting its drug application.

The health regulator had previously rejected Corcept's application for relacorilant, an oral medication designed to treat hypertension in patients suffering from Cushing's syndrome. The corrected letter, dated January 28, emphasized that the FDA had explicitly informed Corcept about "significant review issues" if they proceeded with the submission.

According to an analyst from UBS, the language used in the rejection letter was notably strong for an FDA communication. Corcept indicated that they had followed advice from their regulatory advisors, but the FDA apparently held a firm stance.