Xeris Biopharma scores FDA approval for endogenous Cushing's syndrome drug Recorlev

Ahead of its New Year's Day decision deadline at the FDA, Xeris Biopharma has snagged an approval for Recorlev, a drug formerly known as levoketoconazole.

Based on results from phase 3 studies called Sonics and Logics, the FDA approved the drug for adults with Cushing’s syndrome. Xeris picked up Recorlev earlier this year in its acquisition of rare disease biotech Strongbridge Biopharma. It's planning to launch in the first quarter of 2022.