Corcept Resubmits Key Cushing's Syndrome Drug NDA; FDA Decision Expected in Six Months
CORT has more than doubled off its 52-week low of $28.66.
Summary
Corcept has resubmitted its New Drug Application (NDA) for relacorilant as a treatment for Cushing's Syndrome patients. This follows a previous Complete Response Letter from the FDA for relacorilant in hypercortisolism, as noted in the company's last 10-K. The resubmission is a material step towards potential approval for a key drug in a new indication, addressing a prior regulatory setback. The FDA expects to set a PDUFA date six months after the NDA resubmission.
At the time of this announcement, CORT was trading at $64.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $6.5B. The 52-week trading range was $28.66 to $91.00. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Reuters.