French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Thursday that the US Food and Drug Administration (FDA) has granted priority review for its new drug application for venglustat, an investigational oral therapy for type 3 Gaucher disease (GD3), with a target action date of 25 November 2026.

If approved, venglustat would become the first treatment available in the US targeting the progressive neurological manifestations of GD3 and would expand Sanofi's portfolio for lysosomal storage diseases. The application is supported by data from the Phase 3 LEAP2MONO study, in which venglustat met both primary endpoints and three of four key secondary endpoints in adults and paediatric patients with neurological manifestations of the disease.

Sanofi said venglustat was generally well tolerated in the study, with no new safety signals reported compared with previous studies. The therapy has previously received breakthrough therapy, fast-track, and orphan drug designations from the FDA.

Venglustat is also under regulatory review in the European Union, and the company plans additional global regulatory filings in 2026.