Roche announced that the FDA has granted Priority Review for Enspryng as a treatment for MOGAD. This decision is based on the Phase III METEOROID study, which demonstrated Enspryng's effectiveness in reducing relapses. MOGAD is a rare, unpredictable central nervous system disease causing attacks on the optic nerves, spinal cord, or brain. If approved, Enspryng would become the first disease-modifying therapy specifically for MOGAD. The study showed Enspryng reduced relapse risk by 68% compared to placebo. It also improved secondary measures like MRI lesions and reduced the need for rescue therapies. The safety profile of Enspryng in the study aligns with its established use in NMOSD. The FDA is expected to make an approval decision by January 10, 2027. The European Medicines Agency has also validated Enspryng's application for MOGAD in Europe, with a decision anticipated in the third quarter of 2027. Currently, there are no approved treatments for MOGAD, a debilitating condition that can lead to permanent neurological damage.