Sanofi SEC Filings for December 2025

This report contains two press releases from Sanofi. The first, dated December 17, 2025, announces that efdoralprin alfa has received orphan designation in the EU for alpha-1 antitrypsin deficiency related emphysema. This investigational therapy has shown superiority to standard care in Phase 2 trials and has previously received Fast Track and Orphan Drug designation from the FDA. The second press release, dated December 23, 2025, reports that Dupixent has been approved in Japan for children aged 6 to 11 years with bronchial asthma. This approval is based on Phase 3 studies demonstrating significant reduction in exacerbations and improvement in lung function. Dupixent targets type 2 inflammation driven by IL-4 and IL-13 pathways. Both press releases include forward-looking statements regarding the development and potential of these therapies, alongside detailed information about the respective conditions and the companies involved.