SNY's Nexviazyme Meets Goals in Infantile-Onset Pompe Disease Study

Sanofi’s Phase III Baby-COMET study met all goals for Nexviazyme in infantile-onset Pompe disease, supporting a planned U.S. filing in H2 2026. The successful trial outcome is a meaningful validation step ahead of regulatory review. Overall, the news is likely to be modestly supportive for sentiment around Sanofi’s pipeline into the next regulatory milestone.

Analysis

Sanofi’s Phase III Baby-COMET study met all goals for Nexviazyme in infantile-onset Pompe disease, supporting a planned U.S. filing in H2 2026. The successful trial outcome is a meaningful validation step ahead of regulatory review. Overall, the news is likely to be modestly supportive for sentiment around Sanofi’s pipeline into the next regulatory milestone.