The Prescription Medicines Code of Practice Authority (PMCPA), the UK pharmaceutical industry’s self-regulatory body, has ruled that Sanofi breached the Code of Practice by making unsubstantiated efficacy claims for its Beyfortus RSV prophylactic relative to Pfizer’s competing vaccine. Following a formal complaint, the PMCPA found that Sanofi’s promotional materials cited comparative effectiveness figures without adequate clinical trial evidence or peer-reviewed sources. The ruling requires Sanofi to withdraw the offending promotional items and publish a corrective statement within two weeks, with potential disciplinary sanctions if the company fails to comply. Investors will monitor any reputational or operational fallout, particularly in markets where Beyfortus competes directly with Pfizer’s RSV offering in high-risk pediatric populations.

Sanofi reported topline results from the LEAP2MONO phase 3 study evaluating once-daily oral venglustat versus biweekly intravenous enzyme replacement therapy (ERT) in 43 adults and adolescents aged 12+ with type 3 Gaucher disease. Venglustat met its primary endpoint and three of four key secondary endpoints, matching ERT in spleen volume reduction, liver volume reduction and hemoglobin improvement. The oral agent also demonstrated acceptable safety, with no new signals. Despite a separate phase 3 Fabry disease trial (PERIDOT) failing to meet its primary endpoint for neuropathic and abdominal pain reduction, Sanofi confirmed plans to file global regulatory applications for GD3 by mid-2026 and to complete the ongoing CARAT cardiac study in Fabry disease. The push follows January FDA approval expanding Cerezyme’s label to non-CNS manifestations of GD3 and underscores Sanofi’s strategy to broaden its rare-disease franchise.