Roche Gets FDA Priority Tag for Enspryng in Rare Autoimmune Disorder

Roche's (RHHBY) supplemental biologics license application for Enspryng in myelin oligodendrocyte glycoprotein antibody-associated disease received FDA priority review. The accelerated review designation sets an FDA decision date of Jan. 10, 2027, potentially expanding Enspryng's approved indications in a rare neurological disease.