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.

The primary clinical trial for relacorilant did not demonstrate its superiority over a placebo, showing virtually no difference between the drug and the placebo. Furthermore, the FDA highlighted substantial liver safety concerns, noting that four patients developed probable drug-induced liver injury. One patient exhibited liver enzyme levels exceeding 50 times the upper limit of normal.

Corcept is granted a one-year period to resubmit its application and address other required actions. The FDA's letter also stipulated that a failure to respond would be interpreted as a request to withdraw the application. The corrected letter was made public on Thursday afternoon, following subsequent communications between Corcept and the agency.