The Prescription Medicines Code of Practice Authority (PMCPA) concluded that Sanofi breached the UK Pharma Code of Practice by making unsubstantiated comparative efficacy claims about its Beyfortus RSV therapy relative to Pfizer’s vaccine. Following a formal complaint, the self-regulatory body found that promotional materials and sales rep presentations lacked adequate clinical evidence to support assertions of superior protection and longer duration of immunity. The ruling requires Sanofi to issue corrective communications to healthcare professionals, undergo enhanced compliance training and submit future promotional materials for pre-approval. Investors should monitor potential reputational impacts in the UK and any follow-on sanctions that could affect product rollout or market access in other European markets.

Sanofi reported topline results from the LEAP2MONO pivotal trial in type 3 Gaucher disease showing venglustat met its primary neurologic endpoint and three of four key secondary endpoints—spleen volume, liver volume and hemoglobin level—across 43 adult and adolescent patients. The once-daily oral therapy demonstrated non-inferiority to biweekly intravenous enzyme replacement on non-neurological measures and was well tolerated, with no new safety signals. Sanofi plans global regulatory submissions for GD3 later this year. Conversely, the PERIDOT study in Fabry disease did not achieve its primary pain-reduction endpoint, though both arms saw neuropathic and abdominal pain improvements; further analyses are underway and a second Phase 3 (CARAT) in cardiac outcomes remains ongoing. The mixed results underscore potential near-term regulatory milestones in Gaucher but reflect uncertainty in expanding venglustat’s label beyond central nervous system manifestations.