FDA to Review Corcept's Relacorilant NDA for Cushing's Syndrome in Six Months
CORT has more than doubled off its 52-week low of $28.66.
Summary
Corcept Therapeutics has resubmitted its New Drug Application (NDA) for relacorilant, targeting Cushing's syndrome, with the FDA expected to complete its review within six months. This follows an 8-K filed today confirming the resubmission, which was also reported by news outlets on May 27th. The six-month review timeline provides crucial clarity on the path to potential approval for this key drug candidate. This development is significant for the company, especially after recent negative news regarding Q1 earnings and an ALS trial failure. An FDA decision is anticipated in approximately six months.
At the time of this announcement, CORT was trading at $81.75 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $8.8B. 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 7 out of 10. Source: Wiseek News.