Sanofi

Sanofi announced positive results from its Baby-COMET Phase 3 study for Nexviazyme (avalglucosidase alfa) in infantile-onset Pompe disease (IOPD). The study met its primary endpoint, demonstrating that treatment-naïve infants (zero to six months of age) were alive and free of invasive ventilation at 52 weeks. All secondary endpoints were also met, and the drug was well tolerated with a safety profile consistent with previous findings. Sanofi plans to submit these data to support a regulatory application in the US for IOPD in the second half of 2026.

Sanofi announced multiple significant developments, including the European Commission's approval of Cenrifki (tolebrutinib) for secondary progressive multiple sclerosis without relapses, marking it as the first disability-targeting medicine for this condition. Additionally, the company received approval in Japan for Sarclisa's subcutaneous formulation for multiple myeloma and for Wayrilz to treat immune thrombocytopenia. Sanofi also appointed Paulo Fontoura as the new Global Head of Research & Development Pharma, effective September 1, 2026, bringing extensive experience to the role.

Sanofi announced that its drug, Tzield (teplizumab-mzwv), has received accelerated approval from the US Food and Drug Administration (FDA). This approval is for delaying the decline in endogenous insulin production in children aged eight to 17 years who have been recently diagnosed with stage 3 type 1 diabetes (T1D). Tzield is noted as the first disease-modifying therapy for this specific indication. The approval was supported by data from the PROTECT phase 3 study and additional clinical development program data, with a confirmatory study (BETA-PRESERVE) currently underway.

Sanofi announced that the US Food and Drug Administration (FDA) has granted priority review to its new drug application (NDA) for venglustat, an investigational oral glucosylceramide synthase inhibitor, for the treatment of type 3 Gaucher disease (GD3). This marks a significant step as venglustat aims to be the first treatment in the US to address the progressive neurological manifestations associated with GD3. The FDA's target action date for a decision is November 25, 2026, following positive data from the Phase 3 LEAP2MONO study.

The ElevAATe Phase 2 study demonstrated the superiority of Sanofi's investigational efdoralprin alfa over standard-of-care therapy in achieving and maintaining normalized functional alpha-1 antitrypsin (fAAT) levels in adult patients with AATD-related emphysema. Efdoralprin alfa, dosed every three weeks, achieved mean increases in fAAT trough levels more than three times greater than weekly plasma-derived protein, meeting the primary endpoint. All key secondary endpoints were also met, showing sustained normal fAAT levels for 100% of days during the study, compared to 41% for standard-of-care. The drug was well tolerated with a comparable safety profile.

Sanofi announced that its shareholders approved all resolutions at the Annual General Meeting on April 29, 2026, including the appointment of Belén Garijo as a board member. In line with a prior Board decision, Ms. Garijo will assume her duties as Chief Executive Officer on May 1, 2026. The General Meeting also approved an ordinary annual dividend of 4.12 per share, payable on May 7, 2026. Additionally, the board mandates for Christophe Babule and Jean-Paul Kress were renewed, and Christel Heydemann was welcomed as an independent board member.

Sanofi successfully priced a bond issue totaling 2.3 billion. This financing activity was announced in a press release dated April 24, 2026, and subsequently filed with the SEC.

Sanofi announced significant regulatory milestones, including US FDA approvals for Tzield to delay stage 3 type 1 diabetes in young children and for Dupixent (with Regeneron) as the first biologic for young children with uncontrolled chronic spontaneous urticaria. Additionally, the CHMP recommended EU approval for Cenrifki (tolebrutinib) for secondary progressive multiple sclerosis without relapses. The company also provided an update on the Sarclisa subcutaneous regulatory submission in the US and reported positive tolerability data for its Nuvaxovid COVID-19 vaccine.