The U.S. Food and Drug Administration said on Friday it has approved Sanofi's blood cancer drug, Sarclisa, which can be given under the skin through a wearable injector, offering multiple myeloma patients a less burdensome alternative to intravenous infusions.
The European Commission said on Wednesday it would seek feedback on commitments offered by French pharmaceutical company Sanofi to address concerns that it may have breached competition rules in a flu vaccine marketing campaign.
Sanofi's phase III Baby-COMET study meets all goals for Nexviazyme in infantile-onset Pompe disease, paving the way for a planned U.S. filing in H2 2026.
Sanofi is reiterated as a compelling buy, trading at a pronounced valuation discount versus pharma peers despite solid results and strategic focus. Dupixent drives 40% of Sanofi's sales and 80% of Q1 incremental growth; management is pursuing lifecycle management to mitigate 2031 U.S. LOE risk. Dupixent concentration is not unique. Management continues to pursue lifecycle management initiatives, including new formulations and a hyaluronidase co-formulation, while planning conservatively under a no-extension scenario.
Sanofi wins EU nod for Cenrifki in secondary progressive multiple sclerosis without relapses, while Wayrilz gets Japan nod for immune thrombocytopenia.
The authorization of Cenrifki for the treatment of secondary progressive multiple sclerosis without relapses follows a rejection from U.S. drug regulators.
SNY's Dupixent is expanding into new diseases and geographies, strengthening its position as a key driver of long-term revenue growth.
Sanofi remains a compelling investment opportunity, driven by a robust pipeline and strong fundamentals. Sarclisa sales in Q1 of 2026 grew by 30.1% to $193.21 million; expansion with on-body injector [OBI] could make a push to compete in the MM space against Darzalex. Dupixent sales in Q1 of 2026 grew by 30.8% to $4.85 billion, boosted by continued strong execution and expansion for pediatric patients in CSU.
SNY wins FDA approval to expand Tzield's use in children with newly diagnosed stage 3 T1D, opening treatment to a broader patient group.
The U.S. Food and Drug Administration approved Sanofi's injection to slow the loss of the body's own insulin production in children aged 8 to 17 years recently diagnosed with stage 3 type 1 diabetes, the agency said on Friday.
SNY halts its phase III MOBILIZE study after an interim review finds riliprubart unlikely to deliver sufficient efficacy in refractory CIDP patients.
Biopharmaceutical company Sanofi will stop a Phase 3 trial of its drug riliprubart for a rare neurological condition after an interim analysis of the study found it unlikely to provide sufficient efficacy.