amlitelimab — Topline data
H2 2026
Two additional phase 3 studies, AQUA (clinical study identifier: NCT06241118) and ESTUARY (clinical study identifier: NCT06407934) are anticipated to report results in H2 2026.Source filing
SNY biotech catalysts & pipeline
SANOFI · Data as of 2026-09-08
Upcoming catalysts
amlitelimab — NDA/BLA submission
H2 2026
Results from ESTUARY are anticipated in H2 2026 followed by regulatory submission in the same period.Source filing
belumosudil — NDA/BLA submission
H2 2026
The data will support a regulatory submission for a label extension in the US, anticipated in the second half of 2026.Source filing
efdoralprin alfa — NDA/BLA submission
H2 2026
regulatory submission (US)Source filing
frexalimab — Interim data
H2 2026
phase 2 dataSource filing
influenza vaccine (Fluzone HD / Efluelda) — NDA/BLA submission
H2 2026
regulatory submission (EU)Source filing
Nexviazyme (avalglucosidase alfa) — NDA/BLA submission
H2 2026
regulatory submission (US, EU)Source filing
riliprubart — Topline data
H2 2026
phase 3 dataSource filing
SP0218 — Topline data
H2 2026
phase 3 dataSource filing
Wayrilz (rilzabrutinib) — Regulatory decision
H2 2026
regulatory decision (CN)Source filing
venglustat — PDUFA
Nov 25
The target action date for the FDA decision is November 25, 2026.Source filing