The UK’s Prescription Medicines Code of Practice Authority (PMCPA) ruled that Sanofi breached industry standards by making unsubstantiated claims about the superiority of its monoclonal antibody RSV therapy, Beyfortus, compared with Pfizer’s newly approved vaccine. The decision follows a formal complaint by a competitor and centers on promotional materials used during a medical conference in October 2025. The PMCPA found that Sanofi overstated Beyfortus’s efficacy based on post-hoc subgroup analyses, without presenting full study data or acknowledging limitations. Sanofi has been directed to withdraw the offending materials and submit corrective communications to healthcare professionals within 30 days. Non-compliance could lead to disciplinary measures, including public reprimand or financial penalties.

Sanofi announced topline results from its LEAP2MONO Phase III trial evaluating oral venglustat in type 3 Gaucher disease, enrolling 43 patients aged 12 and above. The study met its primary endpoint—reduction in central nervous system disease markers—and three of four key secondary endpoints, including spleen volume reduction, liver volume reduction and hemoglobin normalization, demonstrating comparable efficacy to biweekly intravenous enzyme replacement therapy. Safety profiles were consistent with earlier studies, with no new adverse events identified. Despite failure to meet the primary endpoint in the companion PERIDOT Phase III trial in Fabry disease, the company plans global regulatory submissions for venglustat in type 3 Gaucher disease by mid-2026 and continues two ongoing studies, CARAT and the open-label extension, to further evaluate cardiac and pain outcomes.