Clinical Trials

Sanofi MS drug hits two setbacks

BioPharma Dive Dec 15, 2025

Sanofi's Tolebrutinib, a drug acquired in a $3.7 billion buyout, failed a Phase 3 study in 'primary progressive' multiple sclerosis and faces a delayed U.S. approval decision for another form of the disease. The FDA decision on the medicine to treat an advanced form of multiple sclerosis will likely be delayed, with further guidance from the regulator at the end of the first quarter, the French drugmaker said, causing shares to plunge.

Discussion

Sign in to join the discussion. Comments loading…