Sanofi's Nexviazyme Achieves Key Endpoints In Infantile-Onset Pompe Disease Phase 3 Study

Sanofi said Nexviazyme (avalglucosidase alfa) met all primary and secondary endpoints in the Baby-COMET Phase 3 trial in treatment-naïve infants with infantile-onset Pompe disease (ages 0–6 months). The study reported infants were alive and free of invasive ventilation (details truncated in the article). If these results support regulatory filings, the data represent a meaningful positive step for Sanofi’s rare-disease pipeline and could be supportive for SNY sentiment.

Analysis

Sanofi said Nexviazyme (avalglucosidase alfa) met all primary and secondary endpoints in the Baby-COMET Phase 3 trial in treatment-naïve infants with infantile-onset Pompe disease (ages 0–6 months). The study reported infants were alive and free of invasive ventilation (details truncated in the article). If these results support regulatory filings, the data represent a meaningful positive step for Sanofi’s rare-disease pipeline and could be supportive for SNY sentiment.