FDA grants priority review to Genentech’s Enspryng for MOGAD - RHHBY News | RalliesFDA grants priority review to Genentech’s Enspryng for MOGAD
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RHHBY• FDA priority review and decision timeline
- FDA granted Priority Review for a supplemental BLA for Genentech’s Enspryng to treat MOGAD.
- Decision deadline set for Jan. 10, 2027; approval would make Enspryng the first disease-modifying therapy for MOGAD.
- Filing backed by Phase III METEOROID results showing a 68% relapse-risk reduction versus placebo.
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