ENXTPA:SANPharmaceuticals
The Bull Case For Sanofi (ENXTPA:SAN) Could Change Following FDA Priority Review Of Tzield Expansion
In recent days, the US FDA accepted a priority review of Sanofi’s supplemental application for Tzield, aiming to extend its use to children aged one year and older with stage 2 type 1 diabetes, supported by interim PETITE-T1D Phase 4 data and a target decision date of April 29, 2026.
This accelerated review could meaningfully broaden Tzield’s eligible pediatric population, underscoring Sanofi’s efforts to address early-stage autoimmune disease in very young patients.
We’ll now examine how...