By Kamal Choudhury
Jan 30 (Reuters) – Shares of Corcept Therapeutics fell 16% on Friday after a corrected “complete response letter” from the U.S. Food and Drug Administration showed the agency had warned the company “on several occasions” not to submit its drug application.
The FDA typically issues complete response letters, or CRLs, when it declines to approve a drug.
The health regulator last year rejected Corcept’s application for relacorilant, an oral drug intended to treat hypertension in patients with Cushing’s syndrome, a rare hormonal disorder caused by prolonged exposure to elevated cortisol activity.
The corrected letter, dated January 28, said the FDA had explicitly told Corcept to “expect significant review issues” if it proceeded with the submission.
UBS analyst Ashwani Verma said it is “rare for FDA to use such language” in a rejection letter. He said Corcept’s management told him “they had submitted based on the advice of their regulatory advisors,” but added that “apparently the FDA had a strong view in this case – based on the language in CRL.” The main clinical trial failed to show relacorilant worked better than placebo, with virtually no difference between the drug and placebo, the letter said. The FDA also raised serious liver safety concerns, noting that four patients developed probable drug-induced liver injury, including one patient with liver enzyme levels more than 50 times the upper limit of normal. Corcept has one year to resubmit its application and take certain other actions, the letter noted, adding that the agency will consider “your lack of response a request to withdraw the application.” Corcept did not immediately respond to a Reuters request for comment. The corrected letter was posted on the FDA’s website on Thursday afternoon, at around 4 p.m. ET, according to Verma.
The original CRL was dated December 30, and the January 28 version was issued following further communications from Corcept.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Maju Samuel)
Comments