SNY · Sanofi

This filing conveys two high-impact clinical and regulatory developments for Sanofi’s immunology pipeline. First, lunsekimig — a novel pentavalent bispecific Nanobody® targeting both TSLP and IL-13 — delivered positive phase 2 data in two respiratory indications: the AIRCULES study (NCT06102005) achieved its primary endpoint of reduced annualized asthma exacerbation rate and key secondary endpoint of improved pre-bronchodilator FEV1 in moderate-to-severe asthma across biomarker subgroups; the DUET study (NCT06454240) met its primary endpoint of improved nasal polyp score and key secondary endpoints of patient-reported congestion and CT-based sinus inflammation in CRSwNP. These outcomes validate the dual-targeting mechanism in upstream (TSLP) and downstream (IL-13) inflammatory pathways and support advancement into ongoing phase 3 trials (PERSEPHONE, THESEUS). Conversely, the VELVET study (NCT06790121) in atopic dermatitis did not meet its primary endpoint (EASI change), indicating potential disease-context specificity for lunsekimig’s mechanism — though secondary skin-clearance measures were positive. Second, Dupixent received a major regulatory expansion: the European Commission approved it for chronic spontaneous urticaria in children aged two to 11 years — the first targeted therapy for this population in the EU — based on pharmacokinetic bridging and safety/efficacy consistency across the LIBERTY-CUPID program (including CUPIDKids, Study A, and Study C). This extends Dupixent’s type 2 inflammation franchise into a fourth pediatric chronic disease, reinforcing its commercial durability and lifecycle management. Both developments underscore Sanofi’s strategic focus on differentiated biologics in immunology, with lunsekimig representing a next-generation candidate and Dupixent continuing to broaden its global label and patient reach. Neither result constitutes regulatory approval for lunsekimig, which remains investigational, nor does the filing disclose financial impact, guidance, or commercial timelines.