30 December 2021 - FDA approval supported by positive results from the pivotal Phase 3 SONICS and LOGICS studies demonstrating Recorlev to be a safe and effective therapeutic option in the treatment of Cushing's syndrome.
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, today announced the U.S. Food and Drug Administration (FDA) approval of Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.