Sanofi Reports Data From Nexviazyme Study, Says It Meets All Endpoints

On Tuesday, Sanofi SA (NASDAQ: SNY ) reported data from the Phase 3 Baby-COMET study of Nexviazyme (avalglucosidase alfa). Read Also: EU Launches Antitrust Probe Into Sanofi Over Allegedly Misleading Flu Vaccine Claims Phase 3 Trial Hits Primary And Secondary Endpoints The trial showed that Nexviazyme met its primary endpoint in treatment-naïve infants with infantile-onset Pompe disease (IOPD), supporting plans for a U.S. regulatory submission seeking a label expansion in the second half of 2026. Pompe disease is a rare, inherited genetic disorder where glycogen builds up in the body’s cells. Caused by a deficiency of the enzyme acid alpha-glucosidase (GAA), it severely weakens skeletal and respiratory muscles. The single-arm, open-label study evaluated infants aged six months or younger and found that the primary endpoint—the proportion of participants alive and free of invasiv...