Sanofi multiple sclerosis therapy rejected by the FDA

Sanofi (SNY) has encountered a setback as the U.S. FDA rejected its marketing application for tolebrutinib, intended for treating non-relapsing secondary progressive multiple sclerosis (nrSPMS). This decision follows Sanofi's recent announcement not to pursue approval for primary progressive multiple sclerosis due to trial failures. The FDA review could extend beyond the December 18 deadline, with further guidance expected in Q1 2026. Sanofi plans to update on an impairment test related to tolebrutinib's asset value with its Q4 results, potentially affecting its 2025 outlook.

https://www.gurufocus.com/news/4086562/sanofi-sny-faces-fda-rejection-for-tolebrutinib-in-ms-treatment